Safety and Efficacy of OMS302 in Subjects Undergoing Unilateral Cataract Extraction With Lens Replacement (CELR)

Sponsor
Omeros Corporation (Industry)
Overall Status
Completed
CT.gov ID
NCT01193127
Collaborator
(none)
223
Enrollment
24
Locations
4
Arms
7.1
Duration (Months)
9.3
Patients Per Site
1.3
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to determine whether the use of OMS302 (the study drug) in individuals undergoing Cataract Extraction with Lens Replacement (CELR) surgery is safe and effective at maintaining an adequately dilated pupil during surgery and reducing post-operative symptoms of discomfort (such as eye pain and irritation).

Condition or DiseaseIntervention/TreatmentPhase
  • Drug: OMS302 Solution
  • Drug: OMS302 Mydriatic Solution
  • Drug: OMS302 Anti-inflammatory Solution
  • Drug: Balanced Salt Solution (BSS) Solution
Phase 2

Study Design

Study Type:
Interventional
Actual Enrollment :
223 participants
Allocation:
Randomized
Intervention Model:
Factorial Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
Study Start Date :
Jul 1, 2010
Actual Primary Completion Date :
Jan 1, 2011
Actual Study Completion Date :
Feb 1, 2011

Arms and Interventions

ArmIntervention/Treatment
Experimental: OMS302 Solution

OMS302 Solution

Drug: OMS302 Solution

Experimental: OMS302 Mydriatic Solution

OMS302 Mydriatic Solution

Drug: OMS302 Mydriatic Solution

Experimental: OMS302 Anti-inflammatory Solution

OMS302 Anti-inflammatory Solution

Drug: OMS302 Anti-inflammatory Solution

Placebo Comparator: Balanced Salt Solution (BSS) Solution

Balanced Salt Solution (BSS) Solution

Drug: Balanced Salt Solution (BSS) Solution

Outcome Measures

Primary Outcome Measures

  1. Pupil Diameter (mm) During Surgery [During surgery (immediately prior to surgical incision to wound closure)]

    Pupil diameter from surgical baseline (immediately prior to surgical incision) to the end of the surgical procedure (wound closure) was summarized using descriptive statistics by treatment group and time point. Repeated measures analyses of variance were used to test for differences in the maintenance of mydriasis. The repeated measures model included change from baseline pupil diameter as the response variable and treatment (OMS302, ketorolac tromethamine, and vehicle), time point (as a categorical variable) and the stratification factor lens opacities classification system II (LOCS II) grade as predictor variables. A generalized estimating equation (GEE) approach with an AR(1) working-correlation structure was used.

  2. Ocular Pain Visual Analog Scale (VAS) Score (mm) Within 12 Hours Postoperatively [through 12 hours post-surgery]

    For the primary analysis of this endpoint, only the results on the day of operation at 2, 4, 6, 8 and 10-12 hours were utilized. The VAS scores (where 0 = no pain and 100 = worst possible pain) were summarized by treatment group and time point. Repeated measures analyses of variance were used to test for differences in postoperative ocular pain. The repeated measures model included VAS pain score as the response variable and treatment (OMS302, phenylephrine hydrochloride (PE), and vehicle), time point (as a categorical variable) and the stratification factor LOCS II grade as predictor variables. A generalized estimating equation (GEE) approach with an AR(1) working correlation structure was used.

Secondary Outcome Measures

  1. Ocular Symptoms Using Numerical Rating System - Tearing, Two Hours Post-Surgery [Two hours]

    The ocular symptom outcomes were based on Ocular Pain and Symptoms Numerical Ordinal Scale (Numerical Rating System - NRS) at each time point for each assessment (tearing, photophobia, eye discharge, itching, foreign body sensation, and haziness). Treatment comparisons were performed using a Cochran-Mantel- Haenszel (CMH) test adjusting for the stratification factor LOCS II grade.

  2. Ocular Symptoms Using Numerical Rating System - Tearing, Six Hours Post-Surgery [Six hours]

    The ocular symptom outcomes were based on Ocular Pain and Symptoms Numerical Ordinal Scale (Numerical Rating System - NRS) at each time point for each assessment (tearing, photophobia, eye discharge, itching, foreign body sensation, and haziness). Treatment comparisons were performed using a Cochran-Mantel-Haenszel (CMH) test adjusting for the stratification factor LOCS II grade.

  3. Ocular Symptoms Using Numerical Rating System - Tearing, One Day Post-Surgery [One day]

    The ocular symptom outcomes were based on Ocular Pain and Symptoms Numerical Ordinal Scale (Numerical Rating System - NRS) at each time point for each assessment (tearing, photophobia, eye discharge, itching, foreign body sensation, and haziness). Treatment comparisons were performed using a Cochran-Mantel-Haenszel (CMH) test adjusting for the stratification factor LOCS II grade.

  4. Ocular Symptoms Using Numerical Rating System - Tearing, Two Days Post-Surgery [Two days]

    The ocular symptom outcomes were based on Ocular Pain and Symptoms Numerical Ordinal Scale (Numerical Rating System - NRS) at each time point for each assessment (tearing, photophobia, eye discharge, itching, foreign body sensation, and haziness). Treatment comparisons were performed using a Cochran-Mantel- Haenszel (CMH) test adjusting for the stratification factor LOCS II grade.

  5. Ocular Symptoms Using Numerical Rating System - Tearing, Seven Days Post-Surgery [Seven days]

    The ocular symptom outcomes were based on Ocular Pain and Symptoms Numerical Ordinal Scale (Numerical Rating System - NRS) at each time point for each assessment (tearing, photophobia, eye discharge, itching, foreign body sensation, and haziness). Treatment comparisons were performed using a Cochran-Mantel- Haenszel (CMH) test adjusting for the stratification factor LOCS II grade.

  6. Ocular Symptoms Using Numerical Rating System - Tearing, 14 Days Post-Surgery [14 days]

    The ocular symptom outcomes were based on Ocular Pain and Symptoms Numerical Ordinal Scale (Numerical Rating System - NRS) at each time point for each assessment (tearing, photophobia, eye discharge, itching, foreign body sensation, and haziness). Treatment comparisons were performed using a Cochran-Mantel- Haenszel (CMH) test adjusting for the stratification factor LOCS II grade.

  7. Ocular Symptoms Using Numerical Rating System - Tearing, 30 Days Post-Surgery/ Early Termination [up to 30 days]

    The ocular symptom outcomes were based on Ocular Pain and Symptoms Numerical Ordinal Scale (Numerical Rating System - NRS) at each time point for each assessment (tearing, photophobia, eye discharge, itching, foreign body sensation, and haziness). Treatment comparisons were performed using a Cochran-Mantel- Haenszel (CMH) test adjusting for the stratification factor LOCS II grade.

  8. Ocular Symptoms Using Numerical Rating System - Photophobia Two Hours Post-Surgery [Two hours]

    The ocular symptom outcomes were based on Ocular Pain and Symptoms Numerical Ordinal Scale (Numerical Rating System - NRS) at each time point for each assessment (tearing, photophobia, eye discharge, itching, foreign body sensation, and haziness). Treatment comparisons were performed using a Cochran-Mantel- Haenszel (CMH) test adjusting for the stratification factor LOCS II grade.

  9. Ocular Symptoms Using Numerical Rating System - Photophobia Six Hours Post-Surgery [Six hours]

    The ocular symptom outcomes were based on Ocular Pain and Symptoms Numerical Ordinal Scale (Numerical Rating System - NRS) at each time point for each assessment (tearing, photophobia, eye discharge, itching, foreign body sensation, and haziness). Treatment comparisons were performed using a Cochran-Mantel- Haenszel (CMH) test adjusting for the stratification factor LOCS II grade.

  10. Ocular Symptoms Using Numerical Rating System - Photophobia One Day Post-Surgery [One day]

    The ocular symptom outcomes were based on Ocular Pain and Symptoms Numerical Ordinal Scale (Numerical Rating System - NRS) at each time point for each assessment (tearing, photophobia, eye discharge, itching, foreign body sensation, and haziness). Treatment comparisons were performed using a Cochran-Mantel- Haenszel (CMH) test adjusting for the stratification factor LOCS II grade.

  11. Ocular Symptoms Using Numerical Rating System - Photophobia Two Days Post-Surgery [Two days]

    The ocular symptom outcomes were based on Ocular Pain and Symptoms Numerical Ordinal Scale (Numerical Rating System - NRS) at each time point for each assessment (tearing, photophobia, eye discharge, itching, foreign body sensation, and haziness). Treatment comparisons were performed using a Cochran-Mantel- Haenszel (CMH) test adjusting for the stratification factor LOCS II grade.

  12. Ocular Symptoms Using Numerical Rating System - Photophobia Seven Days Post-Surgery [Seven days]

    The ocular symptom outcomes were based on Ocular Pain and Symptoms Numerical Ordinal Scale (Numerical Rating System - NRS) at each time point for each assessment (tearing, photophobia, eye discharge, itching, foreign body sensation, and haziness). Treatment comparisons were performed using a Cochran-Mantel- Haenszel (CMH) test adjusting for the stratification factor LOCS II grade.

  13. Ocular Symptoms Using Numerical Rating System - Photophobia 14 Days Post-Surgery [14 days]

    The ocular symptom outcomes were based on Ocular Pain and Symptoms Numerical Ordinal Scale (Numerical Rating System - NRS) at each time point for each assessment (tearing, photophobia, eye discharge, itching, foreign body sensation, and haziness). Treatment comparisons were performed using a Cochran-Mantel- Haenszel (CMH) test adjusting for the stratification factor LOCS II grade.

  14. Ocular Symptoms Using Numerical Rating System - Photophobia 30 Days Post-Surgery /Early Termination [Up to 30 days]

    The ocular symptom outcomes were based on Ocular Pain and Symptoms Numerical Ordinal Scale (Numerical Rating System - NRS) at each time point for each assessment (tearing, photophobia, eye discharge, itching, foreign body sensation, and haziness). Treatment comparisons were performed using a Cochran-Mantel- Haenszel (CMH) test adjusting for the stratification factor LOCS II grade.

  15. Ocular Symptoms Using Numerical Rating System - Eye Discharge 2 Hours Post-Surgery [Two hours]

    The ocular symptom outcomes were based on Ocular Pain and Symptoms Numerical Ordinal Scale (Numerical Rating System - NRS) at each time point for each assessment (tearing, photophobia, eye discharge, itching, foreign body sensation, and haziness). Treatment comparisons were performed using a Cochran-Mantel- Haenszel (CMH) test adjusting for the stratification factor LOCS II grade.

  16. Ocular Symptoms Using Numerical Rating System - Eye Discharge Six Hours Post-Surgery [Six hours]

    The ocular symptom outcomes were based on Ocular Pain and Symptoms Numerical Ordinal Scale (Numerical Rating System - NRS) at each time point for each assessment (tearing, photophobia, eye discharge, itching, foreign body sensation, and haziness). Treatment comparisons were performed using a Cochran-Mantel- Haenszel (CMH) test adjusting for the stratification factor LOCS II grade.

  17. Ocular Symptoms Using Numerical Rating System - Eye Discharge One Day Post-Surgery [One day]

    The ocular symptom outcomes were based on Ocular Pain and Symptoms Numerical Ordinal Scale (Numerical Rating System - NRS) at each time point for each assessment (tearing, photophobia, eye discharge, itching, foreign body sensation, and haziness). Treatment comparisons were performed using a Cochran-Mantel- Haenszel (CMH) test adjusting for the stratification factor LOCS II grade.

  18. Ocular Symptoms Using Numerical Rating System - Eye Discharge Two Days Post-Surgery [Two days]

    The ocular symptom outcomes were based on Ocular Pain and Symptoms Numerical Ordinal Scale (Numerical Rating System - NRS) at each time point for each assessment (tearing, photophobia, eye discharge, itching, foreign body sensation, and haziness). Treatment comparisons were performed using a Cochran-Mantel- Haenszel (CMH) test adjusting for the stratification factor LOCS II grade.

  19. Ocular Symptoms Using Numerical Rating System - Eye Discharge Seven Days Post-Surgery [Seven days]

    The ocular symptom outcomes were based on Ocular Pain and Symptoms Numerical Ordinal Scale (Numerical Rating System - NRS) at each time point for each assessment (tearing, photophobia, eye discharge, itching, foreign body sensation, and haziness). Treatment comparisons were performed using a Cochran-Mantel- Haenszel (CMH) test adjusting for the stratification factor LOCS II grade.

  20. Ocular Symptoms Using Numerical Rating System - Eye Discharge 14 Days Post-Surgery [14 days]

    The ocular symptom outcomes were based on Ocular Pain and Symptoms Numerical Ordinal Scale (Numerical Rating System - NRS) at each time point for each assessment (tearing, photophobia, eye discharge, itching, foreign body sensation, and haziness). Treatment comparisons were performed using a Cochran-Mantel- Haenszel (CMH) test adjusting for the stratification factor LOCS II grade.

  21. Ocular Symptoms Using Numerical Rating System - Eye Discharge 30 Days Post-Surgery/Early Termination [Up to 30 days]

    The ocular symptom outcomes were based on Ocular Pain and Symptoms Numerical Ordinal Scale (Numerical Rating System - NRS) at each time point for each assessment (tearing, photophobia, eye discharge, itching, foreign body sensation, and haziness). Treatment comparisons were performed using a Cochran-Mantel- Haenszel (CMH) test adjusting for the stratification factor LOCS II grade.

  22. Ocular Symptoms Using Numerical Rating System - Itching Two Hours Post-Surgery [Two hours]

    The ocular symptom outcomes were based on Ocular Pain and Symptoms Numerical Ordinal Scale (Numerical Rating System - NRS) at each time point for each assessment (tearing, photophobia, eye discharge, itching, foreign body sensation, and haziness). Treatment comparisons were performed using a Cochran-Mantel- Haenszel (CMH) test adjusting for the stratification factor LOCS II grade.

  23. Ocular Symptoms Using Numerical Rating System - Itching 6 Hours Post-Surgery [Six hours]

    The ocular symptom outcomes were based on Ocular Pain and Symptoms Numerical Ordinal Scale (Numerical Rating System - NRS) at each time point for each assessment (tearing, photophobia, eye discharge, itching, foreign body sensation, and haziness). Treatment comparisons were performed using a Cochran-Mantel- Haenszel (CMH) test adjusting for the stratification factor LOCS II grade.

  24. Ocular Symptoms Using Numerical Rating System - Itching One Day Post-Surgery [One day]

    The ocular symptom outcomes were based on Ocular Pain and Symptoms Numerical Ordinal Scale (Numerical Rating System - NRS) at each time point for each assessment (tearing, photophobia, eye discharge, itching, foreign body sensation, and haziness). Treatment comparisons were performed using a Cochran-Mantel- Haenszel (CMH) test adjusting for the stratification factor LOCS II grade.

  25. Ocular Symptoms Using Numerical Rating System - Itching Two Days Post-Surgery [Two days]

    The ocular symptom outcomes were based on Ocular Pain and Symptoms Numerical Ordinal Scale (Numerical Rating System - NRS) at each time point for each assessment (tearing, photophobia, eye discharge, itching, foreign body sensation, and haziness). Treatment comparisons were performed using a Cochran-Mantel- Haenszel (CMH) test adjusting for the stratification factor LOCS II grade.

  26. Ocular Symptoms Using Numerical Rating System - Itching Seven Days Post-Surgery [Seven days]

    The ocular symptom outcomes were based on Ocular Pain and Symptoms Numerical Ordinal Scale (Numerical Rating System - NRS) at each time point for each assessment (tearing, photophobia, eye discharge, itching, foreign body sensation, and haziness). Treatment comparisons were performed using a Cochran-Mantel- Haenszel (CMH) test adjusting for the stratification factor LOCS II grade.

  27. Ocular Symptoms Using Numerical Rating System - Itching 14 Days Post-Surgery [14 days]

    The ocular symptom outcomes were based on Ocular Pain and Symptoms Numerical Ordinal Scale (Numerical Rating System - NRS) at each time point for each assessment (tearing, photophobia, eye discharge, itching, foreign body sensation, and haziness). Treatment comparisons were performed using a Cochran-Mantel- Haenszel (CMH) test adjusting for the stratification factor LOCS II grade.

  28. Ocular Symptoms Using Numerical Rating System - Itching 30 Days Post-Surgery/Early Termination [Up to 30 days]

    The ocular symptom outcomes were based on Ocular Pain and Symptoms Numerical Ordinal Scale (Numerical Rating System - NRS) at each time point for each assessment (tearing, photophobia, eye discharge, itching, foreign body sensation, and haziness). Treatment comparisons were performed using a Cochran-Mantel- Haenszel (CMH) test adjusting for the stratification factor LOCS II grade.

  29. Ocular Symptoms Using Numerical Rating System - Foreign Body Sensation Two Hours Post-Surgery [Two hours]

    The ocular symptom outcomes were based on Ocular Pain and Symptoms Numerical Ordinal Scale (Numerical Rating System - NRS) at each time point for each assessment (tearing, photophobia, eye discharge, itching, foreign body sensation, and haziness). Treatment comparisons were performed using a Cochran-Mantel- Haenszel (CMH) test adjusting for the stratification factor LOCS II grade.

  30. Ocular Symptoms Using Numerical Rating System - Foreign Body Sensation Six Hours Post-Surgery [Six hours]

    The ocular symptom outcomes were based on Ocular Pain and Symptoms Numerical Ordinal Scale (Numerical Rating System - NRS) at each time point for each assessment (tearing, photophobia, eye discharge, itching, foreign body sensation, and haziness). Treatment comparisons were performed using a Cochran-Mantel- Haenszel (CMH) test adjusting for the stratification factor LOCS II grade.

  31. Ocular Symptoms Using Numerical Rating System - Foreign Body Sensation One Day Post-Surgery [One day]

    The ocular symptom outcomes were based on Ocular Pain and Symptoms Numerical Ordinal Scale (Numerical Rating System - NRS) at each time point for each assessment (tearing, photophobia, eye discharge, itching, foreign body sensation, and haziness). Treatment comparisons were performed using a Cochran-Mantel- Haenszel (CMH) test adjusting for the stratification factor LOCS II grade.

  32. Ocular Symptoms Using Numerical Rating System - Foreign Body Sensation Two Days Post-Surgery [Two days]

    The ocular symptom outcomes were based on Ocular Pain and Symptoms Numerical Ordinal Scale (Numerical Rating System - NRS) at each time point for each assessment (tearing, photophobia, eye discharge, itching, foreign body sensation, and haziness). Treatment comparisons were performed using a Cochran-Mantel- Haenszel (CMH) test adjusting for the stratification factor LOCS II grade.

  33. Ocular Symptoms Using Numerical Rating System - Foreign Body Sensation Seven Days Post-Surgery 7 Days [Seven days]

    The ocular symptom outcomes were based on Ocular Pain and Symptoms Numerical Ordinal Scale (Numerical Rating System - NRS) at each time point for each assessment (tearing, photophobia, eye discharge, itching, foreign body sensation, and haziness). Treatment comparisons were performed using a Cochran-Mantel- Haenszel (CMH) test adjusting for the stratification factor LOCS II grade.

  34. Ocular Symptoms Using Numerical Rating System - Foreign Body Sensation 14 Days Post-Surgery [14 days]

    The ocular symptom outcomes were based on Ocular Pain and Symptoms Numerical Ordinal Scale (Numerical Rating System - NRS) at each time point for each assessment (tearing, photophobia, eye discharge, itching, foreign body sensation, and haziness). Treatment comparisons were performed using a Cochran-Mantel- Haenszel (CMH) test adjusting for the stratification factor LOCS II grade.

  35. Ocular Symptoms Using Numerical Rating System - Foreign Body Sensation 30 Days Post-Surgery/Early Termination [Up to 30 days]

    The ocular symptom outcomes were based on Ocular Pain and Symptoms Numerical Ordinal Scale (Numerical Rating System - NRS) at each time point for each assessment (tearing, photophobia, eye discharge, itching, foreign body sensation, and haziness). Treatment comparisons were performed using a Cochran-Mantel- Haenszel (CMH) test adjusting for the stratification factor LOCS II grade.

  36. Ocular Symptoms Using Numerical Rating System - Haziness Two Hours Post-Surgery [Two hours]

    The ocular symptom outcomes were based on Ocular Pain and Symptoms Numerical Ordinal Scale (Numerical Rating System - NRS) at each time point for each assessment (tearing, photophobia, eye discharge, itching, foreign body sensation, and haziness). Treatment comparisons were performed using a Cochran-Mantel- Haenszel (CMH) test adjusting for the stratification factor LOCS II grade.

  37. Ocular Symptoms Using Numerical Rating System - Haziness Six Hours Post-Surgery [Six hours]

    The ocular symptom outcomes were based on Ocular Pain and Symptoms Numerical Ordinal Scale (Numerical Rating System - NRS) at each time point for each assessment (tearing, photophobia, eye discharge, itching, foreign body sensation, and haziness). Treatment comparisons were performed using a Cochran-Mantel- Haenszel (CMH) test adjusting for the stratification factor LOCS II grade.

  38. Ocular Symptoms Using Numerical Rating System - Haziness One Day Post-Surgery [One day]

    The ocular symptom outcomes were based on Ocular Pain and Symptoms Numerical Ordinal Scale (Numerical Rating System - NRS) at each time point for each assessment (tearing, photophobia, eye discharge, itching, foreign body sensation, and haziness). Treatment comparisons were performed using a Cochran-Mantel- Haenszel (CMH) test adjusting for the stratification factor LOCS II grade.

  39. Ocular Symptoms Using Numerical Rating System - Haziness Two Days Post-Surgery [Two days]

    The ocular symptom outcomes were based on Ocular Pain and Symptoms Numerical Ordinal Scale (Numerical Rating System - NRS) at each time point for each assessment (tearing, photophobia, eye discharge, itching, foreign body sensation, and haziness). Treatment comparisons were performed using a Cochran-Mantel- Haenszel (CMH) test adjusting for the stratification factor LOCS II grade.

  40. Ocular Symptoms Using Numerical Rating System - Haziness Seven Days Post-Surgery [Seven days]

    The ocular symptom outcomes were based on Ocular Pain and Symptoms Numerical Ordinal Scale (Numerical Rating System - NRS) at each time point for each assessment (tearing, photophobia, eye discharge, itching, foreign body sensation, and haziness). Treatment comparisons were performed using a Cochran-Mantel- Haenszel (CMH) test adjusting for the stratification factor LOCS II grade.

  41. Ocular Symptoms Using Numerical Rating System - Haziness 14 Days Post-Surgery [14 days]

    The ocular symptom outcomes were based on Ocular Pain and Symptoms Numerical Ordinal Scale (Numerical Rating System - NRS) at each time point for each assessment (tearing, photophobia, eye discharge, itching, foreign body sensation, and haziness). Treatment comparisons were performed using a Cochran-Mantel- Haenszel (CMH) test adjusting for the stratification factor LOCS II grade.

  42. Ocular Symptoms Using Numerical Rating System - Haziness 30 Days Post-Surgery/Early Termination [Up to 30 days]

    The ocular symptom outcomes were based on Ocular Pain and Symptoms Numerical Ordinal Scale (Numerical Rating System - NRS) at each time point for each assessment (tearing, photophobia, eye discharge, itching, foreign body sensation, and haziness). Treatment comparisons were performed using a Cochran-Mantel- Haenszel (CMH) test adjusting for the stratification factor LOCS II grade.

  43. Best Corrected Visual Acuity (BVCA) - Log Score, Baseline [Baseline]

    Best-Corrected Visual Acuity (BCVA) was summarized by the Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity log score. For subjects without a score due to inability to read the ETDRS chart, the log score was imputed as 1.6 for the purpose of treatment comparisons. Subjects without a score because the manifest refraction was not completed were excluded from the analysis. Treatment comparisons for BCVA were performed by pairwise Wilcoxon tests.

  44. Best Corrected Visual Acuity (BVCA) - Log Score, Day 1 [One day]

    Best-Corrected Visual Acuity (BCVA) was summarized by the ETDRS visual acuity log score. For subjects without a score due to inability to read the ETDRS chart, the log score was imputed as 1.6 for the purpose of treatment comparisons. Subjects without a score because the manifest refraction was not completed were excluded from the analysis. Treatment comparisons for BCVA were performed by pairwise Wilcoxon tests.

  45. Best Corrected Visual Acuity (BVCA) - Log Score, Day 2 [Two days]

    Best-Corrected Visual Acuity (BCVA) was summarized by the ETDRS visual acuity log score. For subjects without a score due to inability to read the ETDRS chart, the log score was imputed as 1.6 for the purpose of treatment comparisons. Subjects without a score because the manifest refraction was not completed were excluded from the analysis. Treatment comparisons for BCVA were performed by pairwise Wilcoxon tests.

  46. Best Corrected Visual Acuity (BVCA) - Log Score, Day 7 [Seven days]

    Best-Corrected Visual Acuity (BCVA) was summarized by the ETDRS visual acuity log score. For subjects without a score due to inability to read the ETDRS chart, the log score was imputed as 1.6 for the purpose of treatment comparisons. Subjects without a score because the manifest refraction was not completed were excluded from the analysis. Treatment comparisons for BCVA were performed by pairwise Wilcoxon tests.

  47. Best Corrected Visual Acuity (BVCA) - Log Score, Day 14 [14 days]

    Best-Corrected Visual Acuity (BCVA) was summarized by the ETDRS visual acuity log score. For subjects without a score due to inability to read the ETDRS chart, the log score was imputed as 1.6 for the purpose of treatment comparisons. Subjects without a score because the manifest refraction was not completed were excluded from the analysis. Treatment comparisons for BCVA were performed by pairwise Wilcoxon tests.

  48. Best Corrected Visual Acuity (BVCA) - Log Score, Day 30 [30 days]

    Best-Corrected Visual Acuity (BCVA) was summarized by the ETDRS visual acuity log score. For subjects without a score due to inability to read the ETDRS chart, the log score was imputed as 1.6 for the purpose of treatment comparisons. Subjects without a score because the manifest refraction was not completed were excluded from the analysis. Treatment comparisons for BCVA were performed by pairwise Wilcoxon tests.

  49. Postoperative Ocular Inflammation in Summed Ocular Inflammation Score (SOIS) Grade, Baseline [Baseline]

    Postoperative inflammation as measured using the Summed Ocular Inflammation Score (SOIS), summarized by treatment arm and time point. Ocular inflammation was evaluated by measuring the anterior chamber cell count and flare using a slit lamp biomicroscope. SOIS was calculated by adding the average of subject's anterior chamber cells and flare grades. The minimum SOIS was 0 (indicating absence of inflammation), whereas the maximum SOIS was 8. Grading was as follows: Anterior Chamber Cells: Grade None = 0/no cells; Grade Mild = +1/1-5 cells; Grade Moderate = +2/6-15 cells; Grade Severe = +3/16-30 cells; Grade Very Severe = +4/>30 cells. Anterior Chamber Flare: Grade None = 0/no Tyndall effect; Grade Mild = +1/barely discernable Tyndall effect; Grade Moderate = +2/moderately intense Tyndall beam in anterior chamber; Grade Severe = +3/severely intense Tyndall beam; Grade Very Severe = +4/very severely intense Tyndall beam with a white and milky appearance to the aqueous

  50. Postoperative Ocular Inflammation in Summed Ocular Inflammation Score (SOIS) Grade, 2 Hours Post Surgery [Two hours]

    TPostoperative inflammation as measured using the Summed Ocular Inflammation Score (SOIS), summarized by treatment arm and time point. Ocular inflammation was evaluated by measuring the anterior chamber cell count and flare using a slit lamp biomicroscope. SOIS was calculated by adding the average of subject's anterior chamber cells and flare grades. The minimum SOIS was 0 (indicating absence of inflammation), whereas the maximum SOIS was 8. Grading was as follows: Anterior Chamber Cells: Grade None = 0/no cells; Grade Mild = +1/1-5 cells; Grade Moderate = +2/6-15 cells; Grade Severe = +3/16-30 cells; Grade Very Severe = +4/>30 cells. Anterior Chamber Flare: Grade None = 0/no Tyndall effect; Grade Mild = +1/barely discernable Tyndall effect; Grade Moderate = +2/moderately intense Tyndall beam in anterior chamber; Grade Severe = +3/severely intense Tyndall beam; Grade Very Severe = +4/very severely intense Tyndall beam with a white and milky appearance to the aqueous

  51. Postoperative Ocular Inflammation in Summed Ocular Inflammation Score (SOIS) Grade, Day 1 [One day]

    Postoperative inflammation as measured using the Summed Ocular Inflammation Score (SOIS), summarized by treatment arm and time point. Ocular inflammation was evaluated by measuring the anterior chamber cell count and flare using a slit lamp biomicroscope. SOIS was calculated by adding the average of subject's anterior chamber cells and flare grades. The minimum SOIS was 0 (indicating absence of inflammation), whereas the maximum SOIS was 8. Grading was as follows: Anterior Chamber Cells: Grade None = 0/no cells; Grade Mild = +1/1-5 cells; Grade Moderate = +2/6-15 cells; Grade Severe = +3/16-30 cells; Grade Very Severe = +4/>30 cells. Anterior Chamber Flare: Grade None = 0/no Tyndall effect; Grade Mild = +1/barely discernable Tyndall effect; Grade Moderate = +2/moderately intense Tyndall beam in anterior chamber; Grade Severe = +3/severely intense Tyndall beam; Grade Very Severe = +4/very severely intense Tyndall beam with a white and milky appearance to the aqueous

  52. Postoperative Ocular Inflammation in Summed Ocular Inflammation Score (SOIS) Grade, Day 2 [Two days]

    Postoperative inflammation as measured using the Summed Ocular Inflammation Score (SOIS), summarized by treatment arm and time point. Ocular inflammation was evaluated by measuring the anterior chamber cell count and flare using a slit lamp biomicroscope. SOIS was calculated by adding the average of subject's anterior chamber cells and flare grades. The minimum SOIS was 0 (indicating absence of inflammation), whereas the maximum SOIS was 8. Grading was as follows: Anterior Chamber Cells: Grade None = 0/no cells; Grade Mild = +1/1-5 cells; Grade Moderate = +2/6-15 cells; Grade Severe = +3/16-30 cells; Grade Very Severe = +4/>30 cells. Anterior Chamber Flare: Grade None = 0/no Tyndall effect; Grade Mild = +1/barely discernable Tyndall effect; Grade Moderate = +2/moderately intense Tyndall beam in anterior chamber; Grade Severe = +3/severely intense Tyndall beam; Grade Very Severe = +4/very severely intense Tyndall beam with a white and milky appearance to the aqueous

  53. Postoperative Ocular Inflammation in Summed Ocular Inflammation Score (SOIS) Grade, Day 7 [Seven days]

    Postoperative inflammation as measured using the Summed Ocular Inflammation Score (SOIS), summarized by treatment arm and time point. Ocular inflammation was evaluated by measuring the anterior chamber cell count and flare using a slit lamp biomicroscope. SOIS was calculated by adding the average of subject's anterior chamber cells and flare grades. The minimum SOIS was 0 (indicating absence of inflammation), whereas the maximum SOIS was 8. Grading was as follows: Anterior Chamber Cells: Grade None = 0/no cells; Grade Mild = +1/1-5 cells; Grade Moderate = +2/6-15 cells; Grade Severe = +3/16-30 cells; Grade Very Severe = +4/>30 cells. Anterior Chamber Flare: Grade None = 0/no Tyndall effect; Grade Mild = +1/barely discernable Tyndall effect; Grade Moderate = +2/moderately intense Tyndall beam in anterior chamber; Grade Severe = +3/severely intense Tyndall beam; Grade Very Severe = +4/very severely intense Tyndall beam with a white and milky appearance to the aqueous

  54. Postoperative Ocular Inflammation in Summed Ocular Inflammation Score (SOIS) Grade, Day 14 [14 days]

    Postoperative inflammation as measured using the Summed Ocular Inflammation Score (SOIS), summarized by treatment arm and time point. Ocular inflammation was evaluated by measuring the anterior chamber cell count and flare using a slit lamp biomicroscope. SOIS was calculated by adding the average of subject's anterior chamber cells and flare grades. The minimum SOIS was 0 (indicating absence of inflammation), whereas the maximum SOIS was 8. Grading was as follows: Anterior Chamber Cells: Grade None = 0/no cells; Grade Mild = +1/1-5 cells; Grade Moderate = +2/6-15 cells; Grade Severe = +3/16-30 cells; Grade Very Severe = +4/>30 cells. Anterior Chamber Flare: Grade None = 0/no Tyndall effect; Grade Mild = +1/barely discernable Tyndall effect; Grade Moderate = +2/moderately intense Tyndall beam in anterior chamber; Grade Severe = +3/severely intense Tyndall beam; Grade Very Severe = +4/very severely intense Tyndall beam with a white and milky appearance to the aqueous

  55. Postoperative Ocular Inflammation in Summed Ocular Inflammation Score (SOIS) Grade, Day 30 [30 days]

    Postoperative inflammation as measured using the Summed Ocular Inflammation Score (SOIS), summarized by treatment arm and time point. Ocular inflammation was evaluated by measuring the anterior chamber cell count and flare using a slit lamp biomicroscope. SOIS was calculated by adding the average of subject's anterior chamber cells and flare grades. The minimum SOIS was 0 (indicating absence of inflammation), whereas the maximum SOIS was 8. Grading was as follows: Anterior Chamber Cells: Grade None = 0/no cells; Grade Mild = +1/1-5 cells; Grade Moderate = +2/6-15 cells; Grade Severe = +3/16-30 cells; Grade Very Severe = +4/>30 cells. Anterior Chamber Flare: Grade None = 0/no Tyndall effect; Grade Mild = +1/barely discernable Tyndall effect; Grade Moderate = +2/moderately intense Tyndall beam in anterior chamber; Grade Severe = +3/severely intense Tyndall beam; Grade Very Severe = +4/very severely intense Tyndall beam with a white and milky appearance to the aqueous

  56. Subjects With Postoperative Ocular Inflammation SOIS = 0, Baseline [Baseline]

    Number of subjects with Summed Ocular Inflammation Score (SOIS) = 0, summarized by treatment arm and time point. Ocular inflammation was evaluated by measuring the anterior chamber cell count and flare using a slit lamp biomicroscope. SOIS was calculated by adding the average of subject's anterior chamber cells and flare grades. The minimum SOIS was 0 (indicating absence of inflammation), whereas the maximum SOIS was 8. Grading was as follows: Anterior Chamber Cells: Grade None = 0/no cells; Grade Mild = +1/1-5 cells; Grade Moderate = +2/6-15 cells; Grade Severe = +3/16-30 cells; Grade Very Severe = +4/>30 cells. Anterior Chamber Flare: Grade None = 0/no Tyndall effect; Grade Mild = +1/barely discernable Tyndall effect; Grade Moderate = +2/moderately intense Tyndall beam in anterior chamber; Grade Severe = +3/severely intense Tyndall beam; Grade Very Severe = +4/very severely intense Tyndall beam with a white and milky appearance to the aqueous

  57. Subjects With Postoperative Ocular Inflammation SOIS = 0, Two Hours Post-surgery [Two hours]

    Number of subjects with Summed Ocular Inflammation Score (SOIS) = 0, summarized by treatment arm and time point. Ocular inflammation was evaluated by measuring the anterior chamber cell count and flare using a slit lamp biomicroscope. SOIS was calculated by adding the average of subject's anterior chamber cells and flare grades. The minimum SOIS was 0 (indicating absence of inflammation), whereas the maximum SOIS was 8. Grading was as follows: Anterior Chamber Cells: Grade None = 0/no cells; Grade Mild = +1/1-5 cells; Grade Moderate = +2/6-15 cells; Grade Severe = +3/16-30 cells; Grade Very Severe = +4/>30 cells. Anterior Chamber Flare: Grade None = 0/no Tyndall effect; Grade Mild = +1/barely discernable Tyndall effect; Grade Moderate = +2/moderately intense Tyndall beam in anterior chamber; Grade Severe = +3/severely intense Tyndall beam; Grade Very Severe = +4/very severely intense Tyndall beam with a white and milky appearance to the aqueous

  58. Subjects With Postoperative Ocular Inflammation SOIS = 0, Day 1 [One day]

    Number of subjects with Summed Ocular Inflammation Score (SOIS) = 0, summarized by treatment arm and time point. Ocular inflammation was evaluated by measuring the anterior chamber cell count and flare using a slit lamp biomicroscope. SOIS was calculated by adding the average of subject's anterior chamber cells and flare grades. The minimum SOIS was 0 (indicating absence of inflammation), whereas the maximum SOIS was 8. Grading was as follows: Anterior Chamber Cells: Grade None = 0/no cells; Grade Mild = +1/1-5 cells; Grade Moderate = +2/6-15 cells; Grade Severe = +3/16-30 cells; Grade Very Severe = +4/>30 cells. Anterior Chamber Flare: Grade None = 0/no Tyndall effect; Grade Mild = +1/barely discernable Tyndall effect; Grade Moderate = +2/moderately intense Tyndall beam in anterior chamber; Grade Severe = +3/severely intense Tyndall beam; Grade Very Severe = +4/very severely intense Tyndall beam with a white and milky appearance to the aqueous

  59. Subjects With Postoperative Ocular Inflammation SOIS = 0, Day 2 [Two days]

    Number of subjects with Summed Ocular Inflammation Score (SOIS) = 0, summarized by treatment arm and time point. Ocular inflammation was evaluated by measuring the anterior chamber cell count and flare using a slit lamp biomicroscope. SOIS was calculated by adding the average of subject's anterior chamber cells and flare grades. The minimum SOIS was 0 (indicating absence of inflammation), whereas the maximum SOIS was 8. Grading was as follows: Anterior Chamber Cells: Grade None = 0/no cells; Grade Mild = +1/1-5 cells; Grade Moderate = +2/6-15 cells; Grade Severe = +3/16-30 cells; Grade Very Severe = +4/>30 cells. Anterior Chamber Flare: Grade None = 0/no Tyndall effect; Grade Mild = +1/barely discernable Tyndall effect; Grade Moderate = +2/moderately intense Tyndall beam in anterior chamber; Grade Severe = +3/severely intense Tyndall beam; Grade Very Severe = +4/very severely intense Tyndall beam with a white and milky appearance to the aqueous

  60. Subjects With Postoperative Ocular Inflammation SOIS = 0, Day 7 [Seven days]

    Number of subjects with Summed Ocular Inflammation Score (SOIS) = 0, summarized by treatment arm and time point. Ocular inflammation was evaluated by measuring the anterior chamber cell count and flare using a slit lamp biomicroscope. SOIS was calculated by adding the average of subject's anterior chamber cells and flare grades. The minimum SOIS was 0 (indicating absence of inflammation), whereas the maximum SOIS was 8. Grading was as follows: Anterior Chamber Cells: Grade None = 0/no cells; Grade Mild = +1/1-5 cells; Grade Moderate = +2/6-15 cells; Grade Severe = +3/16-30 cells; Grade Very Severe = +4/>30 cells. Anterior Chamber Flare: Grade None = 0/no Tyndall effect; Grade Mild = +1/barely discernable Tyndall effect; Grade Moderate = +2/moderately intense Tyndall beam in anterior chamber; Grade Severe = +3/severely intense Tyndall beam; Grade Very Severe = +4/very severely intense Tyndall beam with a white and milky appearance to the aqueous

  61. Subjects With Postoperative Ocular Inflammation SOIS = 0, Day 14 [14 days]

    Number of subjects with Summed Ocular Inflammation Score (SOIS) = 0, summarized by treatment arm and time point. Ocular inflammation was evaluated by measuring the anterior chamber cell count and flare using a slit lamp biomicroscope. SOIS was calculated by adding the average of subject's anterior chamber cells and flare grades. The minimum SOIS was 0 (indicating absence of inflammation), whereas the maximum SOIS was 8. Grading was as follows: Anterior Chamber Cells: Grade None = 0/no cells; Grade Mild = +1/1-5 cells; Grade Moderate = +2/6-15 cells; Grade Severe = +3/16-30 cells; Grade Very Severe = +4/>30 cells. Anterior Chamber Flare: Grade None = 0/no Tyndall effect; Grade Mild = +1/barely discernable Tyndall effect; Grade Moderate = +2/moderately intense Tyndall beam in anterior chamber; Grade Severe = +3/severely intense Tyndall beam; Grade Very Severe = +4/very severely intense Tyndall beam with a white and milky appearance to the aqueous

  62. Subjects With Postoperative Ocular Inflammation SOIS = 0, Day 30 [30 days]

    Number of subjects with Summed Ocular Inflammation Score (SOIS) = 0, summarized by treatment arm and time point. Ocular inflammation was evaluated by measuring the anterior chamber cell count and flare using a slit lamp biomicroscope. SOIS was calculated by adding the average of subject's anterior chamber cells and flare grades. The minimum SOIS was 0 (indicating absence of inflammation), whereas the maximum SOIS was 8. Grading was as follows: Anterior Chamber Cells: Grade None = 0/no cells; Grade Mild = +1/1-5 cells; Grade Moderate = +2/6-15 cells; Grade Severe = +3/16-30 cells; Grade Very Severe = +4/>30 cells. Anterior Chamber Flare: Grade None = 0/no Tyndall effect; Grade Mild = +1/barely discernable Tyndall effect; Grade Moderate = +2/moderately intense Tyndall beam in anterior chamber; Grade Severe = +3/severely intense Tyndall beam; Grade Very Severe = +4/very severely intense Tyndall beam with a white and milky appearance to the aqueous

  63. Postoperative Mean Anterior Chamber Cell Count, Two Hours Post-Surgery [Two hours]

    The mean anterior chamber cell count was calculated as the average of the two anterior chamber cell counts. If a cell count was indicated as > 30, it was imputed as 45 for the purpose of treatment comparisons which was performed using pairwise Wilcoxon tests.

  64. Postoperative Mean Anterior Chamber Cell Count, Day 1 [One day]

    The mean anterior chamber cell count was calculated as the average of the two anterior chamber cell counts. If a cell count was indicated as > 30, it was imputed as 45 for the purpose of treatment comparisons which was performed using pairwise Wilcoxon tests.

  65. Postoperative Mean Anterior Chamber Cell Count, Day 2 [Two days]

    The mean anterior chamber cell count was calculated as the average of the two anterior chamber cell counts. If a cell count was indicated as > 30, it was imputed as 45 for the purpose of treatment comparisons which was performed using pairwise Wilcoxon tests.

  66. Postoperative Mean Anterior Chamber Cell Count, Day 7 [Seven days]

    The mean anterior chamber cell count was calculated as the average of the two anterior chamber cell counts. If a cell count was indicated as > 30, it was imputed as 45 for the purpose of treatment comparisons which was performed using pairwise Wilcoxon tests.

  67. Postoperative Mean Anterior Chamber Cell Count, Day 14 [14 days]

    The mean anterior chamber cell count was calculated as the average of the two anterior chamber cell counts. If a cell count was indicated as > 30, it was imputed as 45 for the purpose of treatment comparisons which was performed using pairwise Wilcoxon tests.

  68. Postoperative Mean Anterior Chamber Cell Count, Day 30 [30 days]

    The mean anterior chamber cell count was calculated as the average of the two anterior chamber cell counts. If a cell count was indicated as > 30, it was imputed as 45 for the purpose of treatment comparisons which was performed using pairwise Wilcoxon tests.

  69. Ocular Pain VAS Score After Day 0 [43 days]

    VAS pain scores (where 0 = no pain and 100 = worst possible pain) after the day of surgery were summarized.

  70. Postoperative Use of Ophthalmic Anti-inflammatory Medications [up to 30 days]

    Ophthalmic anti-inflammatory medications were identified by reviewing concomitant medications. Subject incidence of ophthalmic anti-inflammatory medication use by post-surgery day was presented. Treatment comparisons were performed using a Cochran-Mantel- Haenszel (CMH) test adjusting for the stratification factor LOCS II grade.

  71. Use of Pain Medications at Day 1 [One day]

    Ocular pain medications were identified by reviewing concomitant medications. Subject incidence of ocular pain medication use at day 1 and post day 1 were presented. Treatment comparisons were performed using a Cochran-Mantel- Haenszel (CMH) test adjusting for the stratification factor LOCS II grade.

  72. Use of Pain Medications After Day 1 [up to 30 days]

    Ocular pain medications were identified by reviewing concomitant medications. Subject incidence of ocular pain medication use at day 1 and post day 1 were presented. Treatment comparisons were performed using a Cochran-Mantel- Haenszel (CMH) test adjusting for the stratification factor LOCS II grade.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • Competent and willing to voluntarily provide informed consent

  • 18 years of age or older

  • In good general health needing to undergo cataract extraction with lens replacement surgery in one eye, under topical anesthesia

  • Other inclusion criteria to be evaluated by the investigator

Exclusion Criteria:
  • No allergies to the medications and/or the active ingredients of any of the study medications

  • No medications with the same activities as the of the active ingredients in OMS302 for defined time intervals prior to and after surgery

  • No other significant eye injuries, eye conditions or general medical conditions likely to interfere with the evaluation of the study medication

  • Other exclusion criteria to be evaluated by the investigator

Contacts and Locations

Locations

SiteCityStateCountryPostal Code
1ChandlerArizonaUnited States85224
2GlendaleArizonaUnited States85308
3Little RockArkansasUnited States72205
4Los AngelesCaliforniaUnited States90013
5ParkerColoradoUnited States80134
6LargoFloridaUnited States33770
7North Ft. MyersFloridaUnited States33903
8Panama CityFloridaUnited States32405
9TamaracFloridaUnited States33321
10GurneeIllinoisUnited States60031
11GretnaLouisianaUnited States70056
12Kansas CityMissouriUnited States64111
13St. LouisMissouriUnited States63131
14OmahaNebraskaUnited States68131
15Las VegasNevadaUnited States89135
16AlbuquerqueNew MexicoUnited States87113
17Rockville CentreNew YorkUnited States11570
18Bala CynwydPennsylvaniaUnited States19004
19GoodlettsvilleTennesseeUnited States37072
20AustinTexasUnited States78731
21HoustonTexasUnited States77024
22NacogdochesTexasUnited States75965
23San AntonioTexasUnited States78229
24Salt Lake CityUtahUnited States84132

Sponsors and Collaborators

  • Omeros Corporation

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Omeros Corporation
ClinicalTrials.gov Identifier:
NCT01193127
Other Study ID Numbers:
  • C09-001
First Posted:
Sep 1, 2010
Last Update Posted:
Aug 28, 2014
Last Verified:
Aug 1, 2014

Study Results

Participant Flow

Recruitment Details
Pre-assignment Detail
Arm/Group TitleBalanced Salt Solution (BSS)OMS302 Mydriatic Solution (PE)OMS302 Anti-inflammatory Solution (KE)OMS302 Solution
Arm/Group DescriptionBalanced Salt Solution (BSS) Balanced Salt Solution (BSS)OMS302 Mydriatic Solution OMS302 Mydriatic SolutionOMS302 Anti-inflammatory Solution OMS302 Anti-inflammatory SolutionOMS302 Solution OMS302 Solution
Period Title: Randomized
STARTED57545557
COMPLETED57545556
NOT COMPLETED0001
Period Title: Randomized
STARTED57545556
COMPLETED57545555
NOT COMPLETED0001

Baseline Characteristics

Arm/Group TitleBalanced Salt Solution (BSS)OMS302 Mydriatic Solution (PE)OMS302 Anti-inflammatory Solution (KE)OMS302 SolutionTotal
Arm/Group DescriptionBalanced Salt Solution (BSS) Balanced Salt Solution (BSS)OMS302 Mydriatic Solution OMS302 Mydriatic SolutionOMS302 Anti-inflammatory Solution OMS302 Anti-inflammatory SolutionOMS302 Solution OMS302 SolutionTotal of all reporting groups
Overall Participants57545556222
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]
68.5
(9.6)
67.6
(10.6)
66.8
(8.6)
66.4
(11.2)
67.3
(10.0)
Sex: Female, Male (Count of Participants)
Female
33
57.9%
34
63%
33
60%
37
66.1%
137
61.7%
Male
24
42.1%
20
37%
22
40%
19
33.9%
85
38.3%

Outcome Measures

1. Primary Outcome
TitlePupil Diameter (mm) During Surgery
DescriptionPupil diameter from surgical baseline (immediately prior to surgical incision) to the end of the surgical procedure (wound closure) was summarized using descriptive statistics by treatment group and time point. Repeated measures analyses of variance were used to test for differences in the maintenance of mydriasis. The repeated measures model included change from baseline pupil diameter as the response variable and treatment (OMS302, ketorolac tromethamine, and vehicle), time point (as a categorical variable) and the stratification factor lens opacities classification system II (LOCS II) grade as predictor variables. A generalized estimating equation (GEE) approach with an AR(1) working-correlation structure was used.
Time FrameDuring surgery (immediately prior to surgical incision to wound closure)

Outcome Measure Data

Analysis Population Description
Subjects with interpretable video recordings obtained during surgery.
Arm/Group TitleBalanced Salt Solution (BSS)OMS302 Mydriatic Solution (PE)OMS302 Anti-inflammatory Solution (KE)OMS302 Solution
Arm/Group DescriptionBalanced Salt Solution (BSS) Balanced Salt Solution (BSS)OMS302 Mydriatic Solution OMS302 Mydriatic SolutionOMS302 Anti-inflammatory Solution OMS302 Anti-inflammatory SolutionOMS302 Solution OMS302 Solution
Measure Participants53495249
Baseline; n = 53, 49, 52, 49
8.0
(2.0)
8.0
(1.8)
8.1
(1.6)
9.0
(2.9)
1 minute; n = 53, 48, 52, 48
8.2
(2.1)
8.3
(1.9)
8.3
(1.6)
9.4
(3.1)
2 minutes; n = 53, 49, 52, 49
8.0
(2.0)
8.3
(1.7)
8.2
(1.8)
9.2
(3.2)
3 minutes; n = 53, 49, 52, 49
7.9
(2.2)
8.4
(1.8)
8.1
(1.7)
9.2
(3.1)
4 minutes; n = 52, 49, 52, 49
7.6
(2.0)
8.4
(1.8)
7.9
(1.8)
9.4
(3.1)
5 minutes; n = 52, 49, 51, 48
7.5
(2.3)
8.2
(1.9)
7.9
(1.9)
9.1
(2.8)
6 minutes; n = 51, 45, 50, 48
7.4
(2.6)
8.1
(2.0)
7.7
(1.8)
9.1
(3.1)
7 minutes; n = 45, 37, 44, 43
7.1
(2.7)
8.0
(2.3)
7.2
(2.0)
9.0
(3.1)
8 minutes; n = 34, 28, 40, 36
7.1
(2.7)
7.8
(2.5)
7.1
(2.1)
8.7
(3.0)
9 minutes; n = 27, 25, 32, 32
7.3
(3.0)
8.1
(2.6)
7.0
(1.9)
8.9
(3.0)
10 minutes; n = 26, 19, 25, 28
7.1
(2.5)
8.3
(2.8)
7.0
(1.5)
8.8
(3.2)
11 minutes; n = 24, 18, 22, 27
7.0
(2.9)
8.3
(2.7)
7.1
(1.4)
8.8
(3.2)
12 minutes; n = 22, 17, 20, 23
6.9
(3.0)
8.0
(2.7)
7.0
(1.1)
9.2
(3.8)
13 minutes; n = 14, 13, 16, 17
6.2
(1.6)
8.0
(2.9)
6.8
(1.4)
8.7
(3.3)
14 minutes; n = 10, 8, 13, 10
6.3
(1.8)
7.7
(2.8)
6.5
(1.4)
9.5
(3.0)
15 minutes; n = 8, 7, 8, 9
6.1
(1.6)
7.9
(2.7)
6.9
(2.1)
9.9
(3.7)
16 minutes; n = 7, 6, 7, 6
5.8
(1.9)
8.4
(3.0)
6.7
(1.6)
10.4
(4.8)
17 minutes; n = 7, 5, 6, 5
5.6
(1.8)
7.2
(1.4)
6.8
(1.7)
12.0
(5.1)
18 minutes; n = 6, 3, 5, 5
5.4
(1.6)
7.9
(0.9)
6.8
(3.1)
12.0
(5.6)
19 minutes; n = 3, 3, 4, 5
5.2
(2.1)
7.8
(1.0)
6.7
(3.9)
11.5
(5.0)
20 minutes; n = 2, 2, 2, 3
5.2
(3.2)
8.1
(1.4)
5.2
(0.9)
12.4
(6.3)
21 minutes; n = 2, 2, 0, 3
4.9
(3.3)
8.0
(1.5)
NA
(NA)
12.0
(5.8)
22 minutes; n = 1, 2, 0, 2
2.3
(0)
7.5
(1.5)
NA
(NA)
14.6
(7.6)
23 minutes; n = 1, 1, 0, 2
3.0
(0)
6.6
(0)
NA
(NA)
14.6
(7.1)
24 minutes; n = 1, 1, 0, 2
4.2
(0)
7.1
(0)
NA
(NA)
13.0
(5.7)
25 minutes; n = 1, 1, 0, 2
2.6
(0)
6.4
(0)
NA
(NA)
13.9
(5.9)
26 minutes; n = 1, 0, 0, 1
3.1
(0)
NA
(NA)
NA
(NA)
17.2
(0)
27 minutes; n = 1, 0, 0, 1
3.3
(0)
NA
(NA)
NA
(NA)
17.4
(0)
28 minutes; n = 1, 0, 0, 1
3.6
(0)
NA
(NA)
NA
(NA)
17.1
(0)
29 minutes; n = 1, 0, 0, 1
3.4
(0)
NA
(NA)
NA
(NA)
18.7
(0)
30 minutes; n = 1, 0, 0, 0
4.1
(0)
NA
(NA)
NA
(NA)
NA
(NA)
31 minutes; n = 1, 0, 0, 0
3.2
(0)
NA
(NA)
NA
(NA)
NA
(NA)
Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Balanced Salt Solution (BSS), OMS302 Solution
Comments
Type of Statistical Test Superiority or Other
Comments
Statistical Test of Hypothesisp-Value0.0000
CommentsRepeated measures model includes treatment (OMS302, ketorolac tromethamine, and vehicle), time-point and LOCS II grade as covariates
Methodrepeated measures model
CommentsAll data time points collected used in the analysis.
Method of EstimationEstimation Parameterleast-squares mean difference
Estimated Value0.9
Confidence Interval () 95%
0.6 to 1.1
Parameter Dispersion Type: Standard Error of the Mean
Value: 0.1
Estimation CommentsOMS302 - Vehicle (BSS)
Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection OMS302 Anti-inflammatory Solution (KE), OMS302 Solution
Comments
Type of Statistical Test Superiority or Other
Comments
Statistical Test of Hypothesisp-Value0.0000
CommentsRepeated measures model includes treatment (OMS302, ketorolac tromethamine, and vehicle), time-point and LOCS II grade as covariates.
Methodrepeated measures model
CommentsOMS302 - ketorolac tromethamine
Method of EstimationEstimation Parameterleast-squares mean difference
Estimated Value0.7
Confidence Interval () 95%
0.5 to 0.9
Parameter Dispersion Type: Standard Error of the Mean
Value: 0.1
Estimation Comments
2. Primary Outcome
TitleOcular Pain Visual Analog Scale (VAS) Score (mm) Within 12 Hours Postoperatively
DescriptionFor the primary analysis of this endpoint, only the results on the day of operation at 2, 4, 6, 8 and 10-12 hours were utilized. The VAS scores (where 0 = no pain and 100 = worst possible pain) were summarized by treatment group and time point. Repeated measures analyses of variance were used to test for differences in postoperative ocular pain. The repeated measures model included VAS pain score as the response variable and treatment (OMS302, phenylephrine hydrochloride (PE), and vehicle), time point (as a categorical variable) and the stratification factor LOCS II grade as predictor variables. A generalized estimating equation (GEE) approach with an AR(1) working correlation structure was used.
Time Framethrough 12 hours post-surgery

Outcome Measure Data

Analysis Population Description
Subjects with postoperative VAS scores.
Arm/Group TitleBalanced Salt Solution (BSS)OMS302 Mydriatic Solution (PE)OMS302 Anti-inflammatory Solution (KE)OMS302 Solution
Arm/Group DescriptionBalanced Salt Solution (BSS) Balanced Salt Solution (BSS)OMS302 Mydriatic Solution OMS302 Mydriatic SolutionOMS302 Anti-inflammatory Solution OMS302 Anti-inflammatory SolutionOMS302 Solution OMS302 Solution
Measure Participants56565555
2 hours post-surgery
8.6
(14.7)
9.4
(16.8)
4.1
(12.7)
5.3
(11.8)
4 hours post-surgery
10.9
(19.3)
10.5
(16.9)
4.8
(12.3)
5.9
(12.4)
6 hours post-surgery
10.5
(17.2)
9.5
(14.9)
4.3
(10.9)
3.9
(8.6)
8 hours post-surgery
8.9
(14.7)
12.2
(16.9)
4.0
(11.0)
4.0
(10.5)
10-12 hours post-surgery
10.3
(18.3)
11.8
(17.1)
3.4
(9.2)
4.7
(13.4)
Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Balanced Salt Solution (BSS), OMS302 Solution
Comments
Type of Statistical Test Superiority or Other
Comments
Statistical Test of Hypothesisp-Value0.0421
CommentsRepeated measures model includes treatment (OMS302, PE and vehicle), time point and LOCS II grade as covariates
Methodrepeated measures model
Comments
Method of EstimationEstimation Parameterleast-squares mean difference
Estimated Value-4.6
Confidence Interval () 95%
-8.9 to -0.2
Parameter Dispersion Type: Standard Error of the Mean
Value: 2.2
Estimation CommentsOMS302 - Vehicle (BSS)
Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection OMS302 Mydriatic Solution (PE), OMS302 Solution
Comments
Type of Statistical Test Superiority or Other
Comments
Statistical Test of Hypothesisp-Value0.0093
CommentsRepeated measures model includes treatment (OMS302, PE and vehicle), time point and LOCS II grade as covariates.
Methodrepeated measures model
Comments
Method of EstimationEstimation Parameterleast-squares mean difference
Estimated Value-5.9
Confidence Interval () 95%
-10.3 to -1.5
Parameter Dispersion Type: Standard Error of the Mean
Value: 2.2
Estimation CommentsOMS302 - PE
3. Secondary Outcome
TitleOcular Symptoms Using Numerical Rating System - Tearing, Two Hours Post-Surgery
DescriptionThe ocular symptom outcomes were based on Ocular Pain and Symptoms Numerical Ordinal Scale (Numerical Rating System - NRS) at each time point for each assessment (tearing, photophobia, eye discharge, itching, foreign body sensation, and haziness). Treatment comparisons were performed using a Cochran-Mantel- Haenszel (CMH) test adjusting for the stratification factor LOCS II grade.
Time FrameTwo hours

Outcome Measure Data

Analysis Population Description
Subjects with scores at time point.
Arm/Group TitleBalanced Salt Solution (BSS)OMS302 Mydriatic Solution (PE)OMS302 Anti-inflammatory Solution (KE)OMS302 Solution
Arm/Group DescriptionBalanced Salt Solution (BSS) Balanced Salt Solution (BSS)OMS302 Mydriatic Solution OMS302 Mydriatic SolutionOMS302 Anti-inflammatory Solution OMS302 Anti-inflammatory SolutionOMS302 Solution OMS302 Solution
Measure Participants56565554
None
41
71.9%
34
63%
48
87.3%
35
62.5%
Mild
12
21.1%
13
24.1%
6
10.9%
14
25%
Moderate
3
5.3%
7
13%
0
0%
4
7.1%
Severe
0
0%
2
3.7%
1
1.8%
1
1.8%
Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Balanced Salt Solution (BSS), OMS302 Solution
Comments
Type of Statistical Test Superiority or Other
Comments
Statistical Test of Hypothesisp-Value0.630
CommentsTreatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel-Haenszel test adjusting for the LOCS II grade group.
MethodCochran-Mantel-Haenszel
Comments
Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection OMS302 Mydriatic Solution (PE), OMS302 Solution
Comments
Type of Statistical Test Superiority or Other
Comments
Statistical Test of Hypothesisp-Value0.769
CommentsTreatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel-Haenszel test adjusting for the LOCS II grade group.
MethodCochran-Mantel-Haenszel
Comments
Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection OMS302 Anti-inflammatory Solution (KE), OMS302 Solution
Comments
Type of Statistical Test Superiority or Other
Comments
Statistical Test of Hypothesisp-Value0.025
CommentsTreatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel-Haenszel test adjusting for the LOCS II grade group.
MethodCochran-Mantel-Haenszel
Comments
4. Secondary Outcome
TitleOcular Symptoms Using Numerical Rating System - Tearing, Six Hours Post-Surgery
DescriptionThe ocular symptom outcomes were based on Ocular Pain and Symptoms Numerical Ordinal Scale (Numerical Rating System - NRS) at each time point for each assessment (tearing, photophobia, eye discharge, itching, foreign body sensation, and haziness). Treatment comparisons were performed using a Cochran-Mantel-Haenszel (CMH) test adjusting for the stratification factor LOCS II grade.
Time FrameSix hours

Outcome Measure Data

Analysis Population Description
Subjects with scores at time point.
Arm/Group TitleBalanced Salt Solution (BSS)OMS302 Mydriatic Solution (PE)OMS302 Anti-inflammatory Solution (KE)OMS302 Solution
Arm/Group DescriptionBalanced Salt Solution (BSS) Balanced Salt Solution (BSS)OMS302 Mydriatic Solution OMS302 Mydriatic SolutionOMS302 Anti-inflammatory Solution OMS302 Anti-inflammatory SolutionOMS302 Solution OMS302 Solution
Measure Participants54535050
None
34
59.6%
29
53.7%
43
78.2%
35
62.5%
Mild
12
21.1%
15
27.8%
6
10.9%
13
23.2%
Moderate
7
12.3%
6
11.1%
1
1.8%
1
1.8%
Severe
1
1.8%
3
5.6%
0
0%
1
1.8%
Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Balanced Salt Solution (BSS), OMS302 Solution
Comments
Type of Statistical Test Superiority or Other
Comments
Statistical Test of Hypothesisp-Value0.229
CommentsTreatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel-Haenszel test adjusting for the LOCS II grade group.
MethodCochran-Mantel-Haenszel
Comments
Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection OMS302 Mydriatic Solution (PE), OMS302 Solution
Comments
Type of Statistical Test Superiority or Other
Comments
Statistical Test of Hypothesisp-Value0.162
CommentsTreatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel-Haenszel test adjusting for the LOCS II grade group.
MethodCochran-Mantel-Haenszel
Comments
Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection OMS302 Anti-inflammatory Solution (KE), OMS302 Solution
Comments
Type of Statistical Test Superiority or Other
Comments
Statistical Test of Hypothesisp-Value0.226
CommentsTreatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel-Haenszel test adjusting for the LOCS II grade group.
MethodCochran-Mantel-Haenszel
Comments
5. Secondary Outcome
TitleOcular Symptoms Using Numerical Rating System - Tearing, One Day Post-Surgery
DescriptionThe ocular symptom outcomes were based on Ocular Pain and Symptoms Numerical Ordinal Scale (Numerical Rating System - NRS) at each time point for each assessment (tearing, photophobia, eye discharge, itching, foreign body sensation, and haziness). Treatment comparisons were performed using a Cochran-Mantel-Haenszel (CMH) test adjusting for the stratification factor LOCS II grade.
Time FrameOne day

Outcome Measure Data

Analysis Population Description
Subjects with scores at time point.
Arm/Group TitleBalanced Salt Solution (BSS)OMS302 Mydriatic Solution (PE)OMS302 Anti-inflammatory Solution (KE)OMS302 Solution
Arm/Group DescriptionBalanced Salt Solution (BSS) Balanced Salt Solution (BSS)OMS302 Mydriatic Solution OMS302 Mydriatic SolutionOMS302 Anti-inflammatory Solution OMS302 Anti-inflammatory SolutionOMS302 Solution OMS302 Solution
Measure Participants56555554
None
34
59.6%
29
53.7%
48
87.3%
42
75%
Mild
15
26.3%
19
35.2%
6
10.9%
10
17.9%
Moderate
5
8.8%
4
7.4%
1
1.8%
1
1.8%
Severe
2
3.5%
3
5.6%
0
0%
1
1.8%
Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Balanced Salt Solution (BSS), OMS302 Solution
Comments
Type of Statistical Test Superiority or Other
Comments
Statistical Test of Hypothesisp-Value0.177
CommentsTreatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel-Haenszel test adjusting for the LOCS II grade group.
MethodCochran-Mantel-Haenszel
Comments
Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection OMS302 Mydriatic Solution (PE), OMS302 Solution
Comments
Type of Statistical Test Superiority or Other
Comments
Statistical Test of Hypothesisp-Value0.051
CommentsTreatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel-Haenszel test adjusting for the LOCS II grade group.
MethodCochran-Mantel-Haenszel
Comments
Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection OMS302 Anti-inflammatory Solution (KE), OMS302 Solution
Comments
Type of Statistical Test Superiority or Other
Comments
Statistical Test of Hypothesisp-Value0.497
CommentsTreatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel-Haenszel test adjusting for the LOCS II grade group.
MethodCochran-Mantel-Haenszel
Comments
6. Secondary Outcome
TitleOcular Symptoms Using Numerical Rating System - Tearing, Two Days Post-Surgery
DescriptionThe ocular symptom outcomes were based on Ocular Pain and Symptoms Numerical Ordinal Scale (Numerical Rating System - NRS) at each time point for each assessment (tearing, photophobia, eye discharge, itching, foreign body sensation, and haziness). Treatment comparisons were performed using a Cochran-Mantel- Haenszel (CMH) test adjusting for the stratification factor LOCS II grade.
Time FrameTwo days

Outcome Measure Data

Analysis Population Description
Subjects with scores at time point.
Arm/Group TitleBalanced Salt Solution (BSS)OMS302 Mydriatic Solution (PE)OMS302 Anti-inflammatory Solution (KE)OMS302 Solution
Arm/Group DescriptionBalanced Salt Solution (BSS) Balanced Salt Solution (BSS)OMS302 Mydriatic Solution OMS302 Mydriatic SolutionOMS302 Anti-inflammatory Solution OMS302 Anti-inflammatory SolutionOMS302 Solution OMS302 Solution
Measure Participants56555555
None
37
64.9%
30
55.6%
47
85.5%
41
73.2%
Mild
18
31.6%
18
33.3%
7
12.7%
12
21.4%
Moderate
1
1.8%
6
11.1%
0
0%
1
1.8%
Severe
0
0%
1
1.9%
1
1.8%
1
1.8%
Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Balanced Salt Solution (BSS), OMS302 Solution
Comments
Type of Statistical Test Superiority or Other
Comments
Statistical Test of Hypothesisp-Value0.480
CommentsTreatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel-Haenszel test adjusting for the LOCS II grade group.
MethodCochran-Mantel-Haenszel
Comments
Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection OMS302 Mydriatic Solution (PE), OMS302 Solution
Comments
Type of Statistical Test Superiority or Other
Comments
Statistical Test of Hypothesisp-Value0.090
CommentsTreatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel-Haenszel test adjusting for the LOCS II grade group.
MethodCochran-Mantel-Haenszel
Comments
Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection OMS302 Anti-inflammatory Solution (KE), OMS302 Solution
Comments
Type of Statistical Test Superiority or Other
Comments
Statistical Test of Hypothesisp-Value0.439
CommentsTreatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel-Haenszel test adjusting for the LOCS II grade group.
MethodCochran-Mantel-Haenszel
Comments
7. Secondary Outcome
TitleOcular Symptoms Using Numerical Rating System - Tearing, Seven Days Post-Surgery
DescriptionThe ocular symptom outcomes were based on Ocular Pain and Symptoms Numerical Ordinal Scale (Numerical Rating System - NRS) at each time point for each assessment (tearing, photophobia, eye discharge, itching, foreign body sensation, and haziness). Treatment comparisons were performed using a Cochran-Mantel- Haenszel (CMH) test adjusting for the stratification factor LOCS II grade.
Time FrameSeven days

Outcome Measure Data

Analysis Population Description
Subjects with scores at time point.
Arm/Group TitleBalanced Salt Solution (BSS)OMS302 Mydriatic Solution (PE)OMS302 Anti-inflammatory Solution (KE)OMS302 Solution
Arm/Group DescriptionBalanced Salt Solution (BSS) Balanced Salt Solution (BSS)OMS302 Mydriatic Solution OMS302 Mydriatic SolutionOMS302 Anti-inflammatory Solution OMS302 Anti-inflammatory SolutionOMS302 Solution OMS302 Solution
Measure Participants53565355
None
39
68.4%
33
61.1%
46
83.6%
40
71.4%
Mild
13
22.8%
21
38.9%
5
9.1%
13
23.2%
Moderate
1
1.8%
1
1.9%
2
3.6%
1
1.8%
Severe
0
0%
1
1.9%
0
0%
1
1.8%
Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Balanced Salt Solution (BSS), OMS302 Solution
Comments
Type of Statistical Test Superiority or Other
Comments
Statistical Test of Hypothesisp-Value0.812
CommentsTreatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel-Haenszel test adjusting for the LOCS II grade group.
MethodCochran-Mantel-Haenszel
Comments
Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection OMS302 Mydriatic Solution (PE), OMS302 Solution
Comments
Type of Statistical Test Superiority or Other
Comments
Statistical Test of Hypothesisp-Value0.480
CommentsTreatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel-Haenszel test adjusting for the LOCS II grade group.
MethodCochran-Mantel-Haenszel
Comments
Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection OMS302 Anti-inflammatory Solution (KE), OMS302 Solution
Comments
Type of Statistical Test Superiority or Other
Comments
Statistical Test of Hypothesisp-Value0.160
CommentsTreatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel-Haenszel test adjusting for the LOCS II grade group.
MethodCochran-Mantel-Haenszel
Comments
8. Secondary Outcome
TitleOcular Symptoms Using Numerical Rating System - Tearing, 14 Days Post-Surgery
DescriptionThe ocular symptom outcomes were based on Ocular Pain and Symptoms Numerical Ordinal Scale (Numerical Rating System - NRS) at each time point for each assessment (tearing, photophobia, eye discharge, itching, foreign body sensation, and haziness). Treatment comparisons were performed using a Cochran-Mantel- Haenszel (CMH) test adjusting for the stratification factor LOCS II grade.
Time Frame14 days

Outcome Measure Data

Analysis Population Description
Subjects with scores at time point.
Arm/Group TitleBalanced Salt Solution (BSS)OMS302 Mydriatic Solution (PE)OMS302 Anti-inflammatory Solution (KE)OMS302 Solution
Arm/Group DescriptionBalanced Salt Solution (BSS) Balanced Salt Solution (BSS)OMS302 Mydriatic Solution OMS302 Mydriatic SolutionOMS302 Anti-inflammatory Solution OMS302 Anti-inflammatory SolutionOMS302 Solution OMS302 Solution
Measure Participants55555453
None
44
77.2%
45
83.3%
51
92.7%
42
75%
Mild
7
12.3%
10
18.5%
3
5.5%
11
19.6%
Moderate
4
7%
0
0%
0
0%
0
0%
Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Balanced Salt Solution (BSS), OMS302 Solution
Comments
Type of Statistical Test Superiority or Other
Comments
Statistical Test of Hypothesisp-Value0.085
CommentsTreatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel-Haenszel test adjusting for the LOCS II grade group.
MethodCochran-Mantel-Haenszel
Comments
Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection OMS302 Mydriatic Solution (PE), OMS302 Solution
Comments
Type of Statistical Test Superiority or Other
Comments
Statistical Test of Hypothesisp-Value0.742
CommentsTreatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel-Haenszel test adjusting for the LOCS II grade group.
MethodCochran-Mantel-Haenszel
Comments
Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection OMS302 Anti-inflammatory Solution (KE), OMS302 Solution
Comments
Type of Statistical Test Superiority or Other
Comments
Statistical Test of Hypothesisp-Value0.021
CommentsTreatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel-Haenszel test adjusting for the LOCS II grade group.
MethodCochran-Mantel-Haenszel
Comments
9. Secondary Outcome
TitleOcular Symptoms Using Numerical Rating System - Tearing, 30 Days Post-Surgery/ Early Termination
DescriptionThe ocular symptom outcomes were based on Ocular Pain and Symptoms Numerical Ordinal Scale (Numerical Rating System - NRS) at each time point for each assessment (tearing, photophobia, eye discharge, itching, foreign body sensation, and haziness). Treatment comparisons were performed using a Cochran-Mantel- Haenszel (CMH) test adjusting for the stratification factor LOCS II grade.
Time Frameup to 30 days

Outcome Measure Data

Analysis Population Description
Subjects with scores at time point.
Arm/Group TitleBalanced Salt Solution (BSS)OMS302 Mydriatic Solution (PE)OMS302 Anti-inflammatory Solution (KE)OMS302 Solution
Arm/Group DescriptionBalanced Salt Solution (BSS) Balanced Salt Solution (BSS)OMS302 Mydriatic Solution OMS302 Mydriatic SolutionOMS302 Anti-inflammatory Solution OMS302 Anti-inflammatory SolutionOMS302 Solution OMS302 Solution
Measure Participants55545453
None
43
75.4%
44
81.5%
51
92.7%
49
87.5%
Mild
11
19.3%
9
16.7%
3
5.5%
3
5.4%
Moderate
1
1.8%
1
1.9%
0
0%
1
1.8%
Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Balanced Salt Solution (BSS), OMS302 Solution
Comments
Type of Statistical Test Superiority or Other
Comments
Statistical Test of Hypothesisp-Value0.081
CommentsTreatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel-Haenszel test adjusting for the LOCS II grade group.
MethodCochran-Mantel-Haenszel
Comments
Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection OMS302 Mydriatic Solution (PE), OMS302 Solution
Comments
Type of Statistical Test Superiority or Other
Comments
Statistical Test of Hypothesisp-Value0.202
CommentsTreatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel-Haenszel test adjusting for the LOCS II grade group.
MethodCochran-Mantel-Haenszel
Comments
Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection OMS302 Anti-inflammatory Solution (KE), OMS302 Solution
Comments
Type of Statistical Test Superiority or Other
Comments
Statistical Test of Hypothesisp-Value0.606
CommentsTreatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel-Haenszel test adjusting for the LOCS II grade group.
MethodCochran-Mantel-Haenszel
Comments
10. Secondary Outcome
TitleOcular Symptoms Using Numerical Rating System - Photophobia Two Hours Post-Surgery
DescriptionThe ocular symptom outcomes were based on Ocular Pain and Symptoms Numerical Ordinal Scale (Numerical Rating System - NRS) at each time point for each assessment (tearing, photophobia, eye discharge, itching, foreign body sensation, and haziness). Treatment comparisons were performed using a Cochran-Mantel- Haenszel (CMH) test adjusting for the stratification factor LOCS II grade.
Time FrameTwo hours

Outcome Measure Data

Analysis Population Description
Subjects with scores at time point.
Arm/Group TitleBalanced Salt Solution (BSS)OMS302 Mydriatic Solution (PE)OMS302 Anti-inflammatory Solution (KE)OMS302 Solution
Arm/Group DescriptionBalanced Salt Solution (BSS) Balanced Salt Solution (BSS)OMS302 Mydriatic Solution OMS302 Mydriatic SolutionOMS302 Anti-inflammatory Solution OMS302 Anti-inflammatory SolutionOMS302 Solution OMS302 Solution
Measure Participants56565554
None
37
64.9%
27
50%
36
65.5%
32
57.1%
Mild
13
22.8%
22
40.7%
13
23.6%
16
28.6%
Moderate
4
7%
3
5.6%
6
10.9%
4
7.1%
Severe
2
3.5%
4
7.4%
0
0%
2
3.6%
Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Balanced Salt Solution (BSS), OMS302 Solution
Comments
Type of Statistical Test Superiority or Other
Comments
Statistical Test of Hypothesisp-Value0.893
CommentsTreatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.
MethodCochran-Mantel-Haenszel
Comments
Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection OMS302 Mydriatic Solution (PE), OMS302 Solution
Comments
Type of Statistical Test Superiority or Other
Comments
Statistical Test of Hypothesisp-Value0.553
CommentsTreatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.
MethodCochran-Mantel-Haenszel
Comments
Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection OMS302 Anti-inflammatory Solution (KE), OMS302 Solution
Comments
Type of Statistical Test Superiority or Other
Comments
Statistical Test of Hypothesisp-Value0.412
CommentsTreatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.
MethodCochran-Mantel-Haenszel
Comments
11. Secondary Outcome
TitleOcular Symptoms Using Numerical Rating System - Photophobia Six Hours Post-Surgery
DescriptionThe ocular symptom outcomes were based on Ocular Pain and Symptoms Numerical Ordinal Scale (Numerical Rating System - NRS) at each time point for each assessment (tearing, photophobia, eye discharge, itching, foreign body sensation, and haziness). Treatment comparisons were performed using a Cochran-Mantel- Haenszel (CMH) test adjusting for the stratification factor LOCS II grade.
Time FrameSix hours

Outcome Measure Data

Analysis Population Description
Subjects with scores at time point.
Arm/Group TitleBalanced Salt Solution (BSS)OMS302 Mydriatic Solution (PE)OMS302 Anti-inflammatory Solution (KE)OMS302 Solution
Arm/Group DescriptionBalanced Salt Solution (BSS) Balanced Salt Solution (BSS)OMS302 Mydriatic Solution OMS302 Mydriatic SolutionOMS302 Anti-inflammatory Solution OMS302 Anti-inflammatory SolutionOMS302 Solution OMS302 Solution
Measure Participants53534950
None
26
45.6%
29
53.7%
33
60%
29
51.8%
Mild
17
29.8%
16
29.6%
12
21.8%
18
32.1%
Moderate
7
12.3%
7
13%
4
7.3%
1
1.8%
Severe
3
5.3%
1
1.9%
0
0%
2
3.6%
Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Balanced Salt Solution (BSS), OMS302 Solution
Comments
Type of Statistical Test Superiority or Other
Comments
Statistical Test of Hypothesisp-Value0.186
CommentsTreatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.
MethodCochran-Mantel-Haenszel
Comments
Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection OMS302 Mydriatic Solution (PE), OMS302 Solution
Comments
Type of Statistical Test Superiority or Other
Comments
Statistical Test of Hypothesisp-Value0.191
CommentsTreatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.
MethodCochran-Mantel-Haenszel
Comments
Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection OMS302 Anti-inflammatory Solution (KE), OMS302 Solution
Comments
Type of Statistical Test Superiority or Other
Comments
Statistical Test of Hypothesisp-Value0.167
CommentsTreatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.
MethodCochran-Mantel-Haenszel
Comments
12. Secondary Outcome
TitleOcular Symptoms Using Numerical Rating System - Photophobia One Day Post-Surgery
DescriptionThe ocular symptom outcomes were based on Ocular Pain and Symptoms Numerical Ordinal Scale (Numerical Rating System - NRS) at each time point for each assessment (tearing, photophobia, eye discharge, itching, foreign body sensation, and haziness). Treatment comparisons were performed using a Cochran-Mantel- Haenszel (CMH) test adjusting for the stratification factor LOCS II grade.
Time FrameOne day

Outcome Measure Data

Analysis Population Description
Subjects with scores at time point.
Arm/Group TitleBalanced Salt Solution (BSS)OMS302 Mydriatic Solution (PE)OMS302 Anti-inflammatory Solution (KE)OMS302 Solution
Arm/Group DescriptionBalanced Salt Solution (BSS) Balanced Salt Solution (BSS)OMS302 Mydriatic Solution OMS302 Mydriatic SolutionOMS302 Anti-inflammatory Solution OMS302 Anti-inflammatory SolutionOMS302 Solution OMS302 Solution
Measure Participants56555554
None
20
35.1%
16
29.6%
36
65.5%
23
41.1%
Mild
19
33.3%
22
40.7%
16
29.1%
20
35.7%
Moderate
13
22.8%
11
20.4%
2
3.6%
9
16.1%
Severe
4
7%
6
11.1%
1
1.8%
2
3.6%
Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Balanced Salt Solution (BSS), OMS302 Solution
Comments
Type of Statistical Test Superiority or Other
Comments
Statistical Test of Hypothesisp-Value0.663
CommentsTreatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.
MethodCochran-Mantel-Haenszel
Comments
Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection OMS302 Mydriatic Solution (PE), OMS302 Solution
Comments
Type of Statistical Test Superiority or Other
Comments
Statistical Test of Hypothesisp-Value0.326
CommentsTreatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.
MethodCochran-Mantel-Haenszel
Comments
Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection OMS302 Anti-inflammatory Solution (KE), OMS302 Solution
Comments
Type of Statistical Test Superiority or Other
Comments
Statistical Test of Hypothesisp-Value0.045
CommentsTreatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.
MethodCochran-Mantel-Haenszel
Comments
13. Secondary Outcome
TitleOcular Symptoms Using Numerical Rating System - Photophobia Two Days Post-Surgery
DescriptionThe ocular symptom outcomes were based on Ocular Pain and Symptoms Numerical Ordinal Scale (Numerical Rating System - NRS) at each time point for each assessment (tearing, photophobia, eye discharge, itching, foreign body sensation, and haziness). Treatment comparisons were performed using a Cochran-Mantel- Haenszel (CMH) test adjusting for the stratification factor LOCS II grade.
Time FrameTwo days

Outcome Measure Data

Analysis Population Description
Subjects with scores at time point.
Arm/Group TitleBalanced Salt Solution (BSS)OMS302 Mydriatic Solution (PE)OMS302 Anti-inflammatory Solution (KE)OMS302 Solution
Arm/Group DescriptionBalanced Salt Solution (BSS) Balanced Salt Solution (BSS)OMS302 Mydriatic Solution OMS302 Mydriatic SolutionOMS302 Anti-inflammatory Solution OMS302 Anti-inflammatory SolutionOMS302 Solution OMS302 Solution
Measure Participants56555555
None
26
45.6%
23
42.6%
34
61.8%
19
33.9%
Mild
18
31.6%
24
44.4%
13
23.6%
23
41.1%
Moderate
12
21.1%
4
7.4%
5
9.1%
9
16.1%
Severe
0
0%
4
7.4%
3
5.5%
4
7.1%
Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Balanced Salt Solution (BSS), OMS302 Solution
Comments
Type of Statistical Test Superiority or Other
Comments
Statistical Test of Hypothesisp-Value0.106
CommentsTreatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.
MethodCochran-Mantel-Haenszel
Comments
Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection OMS302 Mydriatic Solution (PE), OMS302 Solution
Comments
Type of Statistical Test Superiority or Other
Comments
Statistical Test of Hypothesisp-Value0.519
CommentsTreatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.
MethodCochran-Mantel-Haenszel
Comments
Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection OMS302 Anti-inflammatory Solution (KE), OMS302 Solution
Comments
Type of Statistical Test Superiority or Other
Comments
Statistical Test of Hypothesisp-Value0.039
CommentsTreatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.
MethodCochran-Mantel-Haenszel
Comments
14. Secondary Outcome
TitleOcular Symptoms Using Numerical Rating System - Photophobia Seven Days Post-Surgery
DescriptionThe ocular symptom outcomes were based on Ocular Pain and Symptoms Numerical Ordinal Scale (Numerical Rating System - NRS) at each time point for each assessment (tearing, photophobia, eye discharge, itching, foreign body sensation, and haziness). Treatment comparisons were performed using a Cochran-Mantel- Haenszel (CMH) test adjusting for the stratification factor LOCS II grade.
Time FrameSeven days

Outcome Measure Data

Analysis Population Description
Subjects with scores at time point.
Arm/Group TitleBalanced Salt Solution (BSS)OMS302 Mydriatic Solution (PE)OMS302 Anti-inflammatory Solution (KE)OMS302 Solution
Arm/Group DescriptionBalanced Salt Solution (BSS) Balanced Salt Solution (BSS)OMS302 Mydriatic Solution OMS302 Mydriatic SolutionOMS302 Anti-inflammatory Solution OMS302 Anti-inflammatory SolutionOMS302 Solution OMS302 Solution
Measure Participants53565355
None
30
52.6%
31
57.4%
37
67.3%
37
66.1%
Mild
18
31.6%
16
29.6%
11
20%
12
21.4%
Moderate
4
7%
8
14.8%
3
5.5%
1
1.8%
Severe
1
1.8%
1
1.9%
2
3.6%
5
8.9%
Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Balanced Salt Solution (BSS), OMS302 Solution
Comments
Type of Statistical Test Superiority or Other
Comments
Statistical Test of Hypothesisp-Value0.100
CommentsTreatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.
MethodCochran-Mantel-Haenszel
Comments
Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection OMS302 Mydriatic Solution (PE), OMS302 Solution
Comments
Type of Statistical Test Superiority or Other
Comments
Statistical Test of Hypothesisp-Value0.029
CommentsTreatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.
MethodCochran-Mantel-Haenszel
Comments
Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection OMS302 Anti-inflammatory Solution (KE), OMS302 Solution
Comments
Type of Statistical Test Superiority or Other
Comments
Statistical Test of Hypothesisp-Value0.525
CommentsTreatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.
MethodCochran-Mantel-Haenszel
Comments
15. Secondary Outcome
TitleOcular Symptoms Using Numerical Rating System - Photophobia 14 Days Post-Surgery
DescriptionThe ocular symptom outcomes were based on Ocular Pain and Symptoms Numerical Ordinal Scale (Numerical Rating System - NRS) at each time point for each assessment (tearing, photophobia, eye discharge, itching, foreign body sensation, and haziness). Treatment comparisons were performed using a Cochran-Mantel- Haenszel (CMH) test adjusting for the stratification factor LOCS II grade.
Time Frame14 days

Outcome Measure Data

Analysis Population Description
Subjects with scores at time point.
Arm/Group TitleBalanced Salt Solution (BSS)OMS302 Mydriatic Solution (PE)OMS302 Anti-inflammatory Solution (KE)OMS302 Solution
Arm/Group DescriptionBalanced Salt Solution (BSS) Balanced Salt Solution (BSS)OMS302 Mydriatic Solution OMS302 Mydriatic SolutionOMS302 Anti-inflammatory Solution OMS302 Anti-inflammatory SolutionOMS302 Solution OMS302 Solution
Measure Participants55555453
None
43
75.4%
35
64.8%
42
76.4%
39
69.6%
Mild
10
17.5%
18
33.3%
9
16.4%
12
21.4%
Moderate
2
3.5%
2
3.7%
3
5.5%
1
1.8%
Severe
0
0%
0
0%
0
0%
1
1.8%
Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Balanced Salt Solution (BSS), OMS302 Solution
Comments
Type of Statistical Test Superiority or Other
Comments
Statistical Test of Hypothesisp-Value0.642
CommentsTreatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.
MethodCochran-Mantel-Haenszel
Comments
Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection OMS302 Mydriatic Solution (PE), OMS302 Solution
Comments
Type of Statistical Test Superiority or Other
Comments
Statistical Test of Hypothesisp-Value0.442
CommentsTreatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.
MethodCochran-Mantel-Haenszel
Comments
Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection OMS302 Anti-inflammatory Solution (KE), OMS302 Solution
Comments
Type of Statistical Test Superiority or Other
Comments
Statistical Test of Hypothesisp-Value0.467
CommentsTreatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.
MethodCochran-Mantel-Haenszel
Comments
16. Secondary Outcome
TitleOcular Symptoms Using Numerical Rating System - Photophobia 30 Days Post-Surgery /Early Termination
DescriptionThe ocular symptom outcomes were based on Ocular Pain and Symptoms Numerical Ordinal Scale (Numerical Rating System - NRS) at each time point for each assessment (tearing, photophobia, eye discharge, itching, foreign body sensation, and haziness). Treatment comparisons were performed using a Cochran-Mantel- Haenszel (CMH) test adjusting for the stratification factor LOCS II grade.
Time FrameUp to 30 days

Outcome Measure Data

Analysis Population Description
Subjects with scores at time point.
Arm/Group TitleBalanced Salt Solution (BSS)OMS302 Mydriatic Solution (PE)OMS302 Anti-inflammatory Solution (KE)OMS302 Solution
Arm/Group DescriptionBalanced Salt Solution (BSS) Balanced Salt Solution (BSS)OMS302 Mydriatic Solution OMS302 Mydriatic SolutionOMS302 Anti-inflammatory Solution OMS302 Anti-inflammatory SolutionOMS302 Solution OMS302 Solution
Measure Participants55545453
None
44
77.2%
36
66.7%
42
76.4%
40
71.4%
Mild
10
17.5%
17
31.5%
12
21.8%
10
17.9%
Moderate
1
1.8%
1
1.9%
0
0%
2
3.6%
Severe
0
0%
0
0%
0
0%
1
1.8%
Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Balanced Salt Solution (BSS), OMS302 Solution
Comments
Type of Statistical Test Superiority or Other
Comments
Statistical Test of Hypothesisp-Value0.695
CommentsTreatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.
MethodCochran-Mantel-Haenszel
Comments
Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection OMS302 Mydriatic Solution (PE), OMS302 Solution
Comments
Type of Statistical Test Superiority or Other
Comments
Statistical Test of Hypothesisp-Value0.355
CommentsTreatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.
MethodCochran-Mantel-Haenszel
Comments
Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection OMS302 Anti-inflammatory Solution (KE), OMS302 Solution
Comments
Type of Statistical Test Superiority or Other
Comments
Statistical Test of Hypothesisp-Value0.369
CommentsTreatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.
MethodCochran-Mantel-Haenszel
Comments
17. Secondary Outcome
TitleOcular Symptoms Using Numerical Rating System - Eye Discharge 2 Hours Post-Surgery
DescriptionThe ocular symptom outcomes were based on Ocular Pain and Symptoms Numerical Ordinal Scale (Numerical Rating System - NRS) at each time point for each assessment (tearing, photophobia, eye discharge, itching, foreign body sensation, and haziness). Treatment comparisons were performed using a Cochran-Mantel- Haenszel (CMH) test adjusting for the stratification factor LOCS II grade.
Time FrameTwo hours

Outcome Measure Data

Analysis Population Description
Subjects with scores at time point.
Arm/Group TitleSolutionOMS302 Mydriatic Solution (PE)OMS302 Anti-inflammatory Solution (KE)OMS302 Solution
Arm/Group DescriptionBalanced Salt Solution (BSS) Balanced Salt Solution (BSS)OMS302 Mydriatic Solution OMS302 Mydriatic SolutionOMS302 Anti-inflammatory Solution OMS302 Anti-inflammatory SolutionOMS302 Solution OMS302 Solution
Measure Participants56565554
None
55
96.5%
50
92.6%
52
94.5%
48
85.7%
Mild
1
1.8%
6
11.1%
2
3.6%
4
7.1%
Moderate
0
0%
0
0%
0
0%
2
3.6%
Severe
0
0%
0
0%
1
1.8%
0
0%
Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Balanced Salt Solution (BSS), OMS302 Solution
Comments
Type of Statistical Test Superiority or Other
Comments
Statistical Test of Hypothesisp-Value0.124
CommentsTreatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.
MethodCochran-Mantel-Haenszel
Comments
Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection OMS302 Mydriatic Solution (PE), OMS302 Solution
Comments
Type of Statistical Test Superiority or Other
Comments
Statistical Test of Hypothesisp-Value0.298
CommentsTreatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.
MethodCochran-Mantel-Haenszel
Comments
Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection OMS302 Anti-inflammatory Solution (KE), OMS302 Solution
Comments
Type of Statistical Test Superiority or Other
Comments
Statistical Test of Hypothesisp-Value0.291
CommentsTreatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.
MethodCochran-Mantel-Haenszel
Comments
18. Secondary Outcome
TitleOcular Symptoms Using Numerical Rating System - Eye Discharge Six Hours Post-Surgery
DescriptionThe ocular symptom outcomes were based on Ocular Pain and Symptoms Numerical Ordinal Scale (Numerical Rating System - NRS) at each time point for each assessment (tearing, photophobia, eye discharge, itching, foreign body sensation, and haziness). Treatment comparisons were performed using a Cochran-Mantel- Haenszel (CMH) test adjusting for the stratification factor LOCS II grade.
Time FrameSix hours

Outcome Measure Data

Analysis Population Description
Subjects with scores at time point.
Arm/Group TitleBalanced Salt Solution (BSS)OMS302 Mydriatic Solution (PE)OMS302 Anti-inflammatory Solution (KE)OMS302 Solution
Arm/Group DescriptionBalanced Salt Solution (BSS) Balanced Salt Solution (BSS)OMS302 Mydriatic Solution OMS302 Mydriatic SolutionOMS302 Anti-inflammatory Solution OMS302 Anti-inflammatory SolutionOMS302 Solution OMS302 Solution
Measure Participants54535050
None
44
77.2%
49
90.7%
41
74.5%
43
76.8%
Mild
7
12.3%
1
1.9%
8
14.5%
5
8.9%
Moderate
3
5.3%
3
5.6%
1
1.8%
2
3.6%
Severe
0
0%
0
0%
0
0%
0
0%
Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Balanced Salt Solution (BSS), OMS302 Solution
Comments
Type of Statistical Test Superiority or Other
Comments
Statistical Test of Hypothesisp-Value0.825
CommentsTreatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.
MethodCochran-Mantel-Haenszel
Comments
Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection OMS302 Mydriatic Solution (PE), OMS302 Solution
Comments
Type of Statistical Test Superiority or Other
Comments
Statistical Test of Hypothesisp-Value0.211
CommentsTreatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.
MethodCochran-Mantel-Haenszel
Comments
Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection OMS302 Anti-inflammatory Solution (KE), OMS302 Solution
Comments
Type of Statistical Test Superiority or Other
Comments
Statistical Test of Hypothesisp-Value0.589
CommentsTreatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.
MethodCochran-Mantel-Haenszel
Comments
19. Secondary Outcome
TitleOcular Symptoms Using Numerical Rating System - Eye Discharge One Day Post-Surgery
DescriptionThe ocular symptom outcomes were based on Ocular Pain and Symptoms Numerical Ordinal Scale (Numerical Rating System - NRS) at each time point for each assessment (tearing, photophobia, eye discharge, itching, foreign body sensation, and haziness). Treatment comparisons were performed using a Cochran-Mantel- Haenszel (CMH) test adjusting for the stratification factor LOCS II grade.
Time FrameOne day

Outcome Measure Data

Analysis Population Description
Subjects with scores at time point.
Arm/Group TitleBalanced Salt Solution (BSS)OMS302 Mydriatic Solution (PE)OMS302 Anti-inflammatory Solution (KE)OMS302 Solution
Arm/Group DescriptionBalanced Salt Solution (BSS) Balanced Salt Solution (BSS)OMS302 Mydriatic Solution OMS302 Mydriatic SolutionOMS302 Anti-inflammatory Solution OMS302 Anti-inflammatory SolutionOMS302 Solution OMS302 Solution
Measure Participants56555554
None
48
84.2%
45
83.3%
48
87.3%
50
89.3%
Mild
7
12.3%
9
16.7%
6
10.9%
4
7.1%
Moderate
0
0%
1
1.9%
1
1.8%
0
0%
Severe
1
1.8%
0
0%
0
0%
0
0%
Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Balanced Salt Solution (BSS), OMS302 Solution
Comments
Type of Statistical Test Superiority or Other
Comments
Statistical Test of Hypothesisp-Value0.401
CommentsTreatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.
MethodCochran-Mantel-Haenszel
Comments
Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection OMS302 Mydriatic Solution (PE), OMS302 Solution
Comments
Type of Statistical Test Superiority or Other
Comments
Statistical Test of Hypothesisp-Value0.200
CommentsTreatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.
MethodChi-squared, Corrected
Comments
Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection OMS302 Anti-inflammatory Solution (KE), OMS302 Solution
Comments
Type of Statistical Test Superiority or Other
Comments
Statistical Test of Hypothesisp-Value0.478
CommentsTreatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.
MethodCochran-Mantel-Haenszel
Comments
20. Secondary Outcome
TitleOcular Symptoms Using Numerical Rating System - Eye Discharge Two Days Post-Surgery
DescriptionThe ocular symptom outcomes were based on Ocular Pain and Symptoms Numerical Ordinal Scale (Numerical Rating System - NRS) at each time point for each assessment (tearing, photophobia, eye discharge, itching, foreign body sensation, and haziness). Treatment comparisons were performed using a Cochran-Mantel- Haenszel (CMH) test adjusting for the stratification factor LOCS II grade.
Time FrameTwo days

Outcome Measure Data

Analysis Population Description
Subjects with scores at time point.
Arm/Group TitleBalanced Salt Solution (BSS)OMS302 Mydriatic Solution (PE)OMS302 Anti-inflammatory Solution (KE)OMS302 Solution
Arm/Group DescriptionBalanced Salt Solution (BSS) Balanced Salt Solution (BSS)OMS302 Mydriatic Solution OMS302 Mydriatic SolutionOMS302 Anti-inflammatory Solution OMS302 Anti-inflammatory SolutionOMS302 Solution OMS302 Solution
Measure Participants56555555
None
52
91.2%
48
88.9%
46
83.6%
49
87.5%
Mild
3
5.3%
7
13%
8
14.5%
5
8.9%
Moderate
1
1.8%
0
0%
0
0%
1
1.8%
Severe
0
0%
0
0%
1
1.8%
0
0%
Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Balanced Salt Solution (BSS), OMS302 Solution
Comments
Type of Statistical Test Superiority or Other
Comments
Statistical Test of Hypothesisp-Value0.758
CommentsTreatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.
MethodCochran-Mantel-Haenszel
Comments
Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection OMS302 Mydriatic Solution (PE), OMS302 Solution
Comments
Type of Statistical Test Superiority or Other
Comments
Statistical Test of Hypothesisp-Value0.521
CommentsTreatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.
MethodCochran-Mantel-Haenszel
Comments
Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection OMS302 Anti-inflammatory Solution (KE), OMS302 Solution
Comments
Type of Statistical Test Superiority or Other
Comments
Statistical Test of Hypothesisp-Value0.432
CommentsTreatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.
MethodCochran-Mantel-Haenszel
Comments
21. Secondary Outcome
TitleOcular Symptoms Using Numerical Rating System - Eye Discharge Seven Days Post-Surgery
DescriptionThe ocular symptom outcomes were based on Ocular Pain and Symptoms Numerical Ordinal Scale (Numerical Rating System - NRS) at each time point for each assessment (tearing, photophobia, eye discharge, itching, foreign body sensation, and haziness). Treatment comparisons were performed using a Cochran-Mantel- Haenszel (CMH) test adjusting for the stratification factor LOCS II grade.
Time FrameSeven days

Outcome Measure Data

Analysis Population Description
Subjects with scores at time point.
Arm/Group TitleBalanced Salt Solution (BSS)OMS302 Mydriatic Solution (PE)OMS302 Anti-inflammatory Solution (KE)OMS302 Solution
Arm/Group DescriptionBalanced Salt Solution (BSS) Balanced Salt Solution (BSS)OMS302 Mydriatic Solution OMS302 Mydriatic SolutionOMS302 Anti-inflammatory Solution OMS302 Anti-inflammatory SolutionOMS302 Solution OMS302 Solution
Measure Participants53565355
None
49
86%
52
96.3%
52
94.5%
52
92.9%
Mild
4
7%
4
7.4%
1
1.8%
1
1.8%
Moderate
0
0%
0
0%
0
0%
2
3.6%
Severe
0
0%
0
0%
0
0%
0
0%
Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Balanced Salt Solution (BSS), OMS302 Solution
Comments
Type of Statistical Test Superiority or Other
Comments
Statistical Test of Hypothesisp-Value0.148
CommentsTreatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.
MethodCochran-Mantel-Haenszel
Comments
Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection OMS302 Mydriatic Solution (PE), OMS302 Solution
Comments
Type of Statistical Test Superiority or Other
Comments
Statistical Test of Hypothesisp-Value0.156
CommentsTreatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.
MethodCochran-Mantel-Haenszel
Comments
Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection OMS302 Anti-inflammatory Solution (KE), OMS302 Solution
Comments
Type of Statistical Test Superiority or Other
Comments
Statistical Test of Hypothesisp-Value0.381
CommentsTreatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.
MethodCochran-Mantel-Haenszel
Comments
22. Secondary Outcome
TitleOcular Symptoms Using Numerical Rating System - Eye Discharge 14 Days Post-Surgery
DescriptionThe ocular symptom outcomes were based on Ocular Pain and Symptoms Numerical Ordinal Scale (Numerical Rating System - NRS) at each time point for each assessment (tearing, photophobia, eye discharge, itching, foreign body sensation, and haziness). Treatment comparisons were performed using a Cochran-Mantel- Haenszel (CMH) test adjusting for the stratification factor LOCS II grade.
Time Frame14 days

Outcome Measure Data

Analysis Population Description
Subjects with scores at time point.
Arm/Group TitleBalanced Salt Solution (BSS)OMS302 Mydriatic Solution (PE)OMS302 Anti-inflammatory Solution (KE)OMS302 Solution
Arm/Group DescriptionBalanced Salt Solution (BSS) Balanced Salt Solution (BSS)OMS302 Mydriatic Solution OMS302 Mydriatic SolutionOMS302 Anti-inflammatory Solution OMS302 Anti-inflammatory SolutionOMS302 Solution OMS302 Solution
Measure Participants55555453
None
52
91.2%
51
94.4%
53
96.4%
49
87.5%
Mild
3
5.3%
4
7.4%
1
1.8%
4
7.1%
Moderate
0
0%
0
0%
0
0%
0
0%
Severe
0
0%
0
0%
0
0%
0
0%
Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Balanced Salt Solution (BSS), OMS302 Solution
Comments
Type of Statistical Test Superiority or Other
Comments
Statistical Test of Hypothesisp-Value0.646
CommentsTreatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.
MethodCochran-Mantel-Haenszel
Comments
Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection OMS302 Mydriatic Solution (PE), OMS302 Solution
Comments
Type of Statistical Test Superiority or Other
Comments
Statistical Test of Hypothesisp-Value0.950
CommentsTreatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.
MethodCochran-Mantel-Haenszel
Comments
Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection OMS302 Anti-inflammatory Solution (KE), OMS302 Solution
Comments
Type of Statistical Test Superiority or Other
Comments
Statistical Test of Hypothesisp-Value0.160
CommentsTreatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.
MethodCochran-Mantel-Haenszel
Comments
23. Secondary Outcome
TitleOcular Symptoms Using Numerical Rating System - Eye Discharge 30 Days Post-Surgery/Early Termination
DescriptionThe ocular symptom outcomes were based on Ocular Pain and Symptoms Numerical Ordinal Scale (Numerical Rating System - NRS) at each time point for each assessment (tearing, photophobia, eye discharge, itching, foreign body sensation, and haziness). Treatment comparisons were performed using a Cochran-Mantel- Haenszel (CMH) test adjusting for the stratification factor LOCS II grade.
Time FrameUp to 30 days

Outcome Measure Data

Analysis Population Description
Subjects with scores at time point.
Arm/Group TitleBalanced Salt Solution (BSS)OMS302 Mydriatic Solution (PE)OMS302 Anti-inflammatory Solution (KE)OMS302 Solution
Arm/Group DescriptionBalanced Salt Solution (BSS) Balanced Salt Solution (BSS)OMS302 Mydriatic Solution OMS302 Mydriatic SolutionOMS302 Anti-inflammatory Solution OMS302 Anti-inflammatory SolutionOMS302 Solution OMS302 Solution
Measure Participants55545453
None
52
91.2%
52
96.3%
53
96.4%
50
89.3%
Mild
3
5.3%
2
3.7%
1
1.8%
3
5.4%
Moderate
0
0%
0
0%
0
0%
0
0%
Severe
0
0%
0
0%
0
0%
0
0%
Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Balanced Salt Solution (BSS), OMS302 Solution
Comments
Type of Statistical Test Superiority or Other
Comments
Statistical Test of Hypothesisp-Value1.000
CommentsTreatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.
MethodCochran-Mantel-Haenszel
Comments
Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection OMS302 Mydriatic Solution (PE), OMS302 Solution
Comments
Type of Statistical Test Superiority or Other
Comments
Statistical Test of Hypothesisp-Value0.667
CommentsTreatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.
MethodCochran-Mantel-Haenszel
Comments
Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection OMS302 Anti-inflammatory Solution (KE), OMS302 Solution
Comments
Type of Statistical Test Superiority or Other
Comments
Statistical Test of Hypothesisp-Value0.303
CommentsTreatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.
MethodCochran-Mantel-Haenszel
Comments
24. Secondary Outcome
TitleOcular Symptoms Using Numerical Rating System - Itching Two Hours Post-Surgery
DescriptionThe ocular symptom outcomes were based on Ocular Pain and Symptoms Numerical Ordinal Scale (Numerical Rating System - NRS) at each time point for each assessment (tearing, photophobia, eye discharge, itching, foreign body sensation, and haziness). Treatment comparisons were performed using a Cochran-Mantel- Haenszel (CMH) test adjusting for the stratification factor LOCS II grade.
Time FrameTwo hours

Outcome Measure Data

Analysis Population Description
Subjects with scores at time point.
Arm/Group TitleBalanced Salt Solution (BSS)OMS302 Mydriatic Solution (PE)OMS302 Anti-inflammatory Solution (KE)OMS302 Solution
Arm/Group DescriptionBalanced Salt Solution (BSS) Balanced Salt Solution (BSS)OMS302 Mydriatic Solution OMS302 Mydriatic SolutionOMS302 Anti-inflammatory Solution OMS302 Anti-inflammatory SolutionOMS302 Solution OMS302 Solution
Measure Participants56565554
None
49
86%
48
88.9%
45
81.8%
47
83.9%
Mild
5
8.8%
7
13%
9
16.4%
6
10.7%
Moderate
1
1.8%
1
1.9%
1
1.8%
1
1.8%
Severe
1
1.8%
0
0%
0
0%
0
0%
Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Balanced Salt Solution (BSS), OMS302 Solution
Comments
Type of Statistical Test Superiority or Other
Comments
Statistical Test of Hypothesisp-Value0.789
CommentsTreatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.
MethodCochran-Mantel-Haenszel
Comments
Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection OMS302 Mydriatic Solution (PE), OMS302 Solution
Comments
Type of Statistical Test Superiority or Other
Comments
Statistical Test of Hypothesisp-Value0.977
CommentsTreatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.
MethodCochran-Mantel-Haenszel
Comments
Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection OMS302 Anti-inflammatory Solution (KE), OMS302 Solution
Comments
Type of Statistical Test Superiority or Other
Comments
Statistical Test of Hypothesisp-Value0.336
CommentsTreatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.
MethodCochran-Mantel-Haenszel
Comments
25. Secondary Outcome
TitleOcular Symptoms Using Numerical Rating System - Itching 6 Hours Post-Surgery
DescriptionThe ocular symptom outcomes were based on Ocular Pain and Symptoms Numerical Ordinal Scale (Numerical Rating System - NRS) at each time point for each assessment (tearing, photophobia, eye discharge, itching, foreign body sensation, and haziness). Treatment comparisons were performed using a Cochran-Mantel- Haenszel (CMH) test adjusting for the stratification factor LOCS II grade.
Time FrameSix hours

Outcome Measure Data

Analysis Population Description
Subjects with scores at time point.
Arm/Group TitleBalanced Salt Solution (BSS)OMS302 Mydriatic Solution (PE)OMS302 Anti-inflammatory Solution (KE)OMS302 Solution
Arm/Group DescriptionBalanced Salt Solution (BSS) Balanced Salt Solution (BSS)OMS302 Mydriatic Solution OMS302 Mydriatic SolutionOMS302 Anti-inflammatory Solution OMS302 Anti-inflammatory SolutionOMS302 Solution OMS302 Solution
Measure Participants54534950
None
44
77.2%
43
79.6%
39
70.9%
43
76.8%
Mild
7
12.3%
9
16.7%
10
18.2%
6
10.7%
Moderate
3
5.3%
1
1.9%
0
0%
1
1.8%
Severe
0
0%
0
0%
0
0%
0
0%
Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Balanced Salt Solution (BSS), OMS302 Solution
Comments
Type of Statistical Test Superiority or Other
Comments
Statistical Test of Hypothesisp-Value0.632
CommentsTreatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.
MethodCochran-Mantel-Haenszel
Comments
Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection OMS302 Mydriatic Solution (PE), OMS302 Solution
Comments
Type of Statistical Test Superiority or Other
Comments
Statistical Test of Hypothesisp-Value0.778
CommentsTreatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.
MethodCochran-Mantel-Haenszel
Comments
Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection OMS302 Anti-inflammatory Solution (KE), OMS302 Solution
Comments
Type of Statistical Test Superiority or Other
Comments
Statistical Test of Hypothesisp-Value0.336
CommentsTreatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.
MethodCochran-Mantel-Haenszel
Comments
26. Secondary Outcome
TitleOcular Symptoms Using Numerical Rating System - Itching One Day Post-Surgery
DescriptionThe ocular symptom outcomes were based on Ocular Pain and Symptoms Numerical Ordinal Scale (Numerical Rating System - NRS) at each time point for each assessment (tearing, photophobia, eye discharge, itching, foreign body sensation, and haziness). Treatment comparisons were performed using a Cochran-Mantel- Haenszel (CMH) test adjusting for the stratification factor LOCS II grade.
Time FrameOne day

Outcome Measure Data

Analysis Population Description
Subjects with scores at time point.
Arm/Group TitleBalanced Salt Solution (BSS)OMS302 Mydriatic Solution (PE)OMS302 Anti-inflammatory Solution (KE)OMS302 Solution
Arm/Group DescriptionBalanced Salt Solution (BSS) Balanced Salt Solution (BSS)OMS302 Mydriatic Solution OMS302 Mydriatic SolutionOMS302 Anti-inflammatory Solution OMS302 Anti-inflammatory SolutionOMS302 Solution OMS302 Solution
Measure Participants56555554
None
45
78.9%
49
90.7%
49
89.1%
46
82.1%
Mild
10
17.5%
6
11.1%
6
10.9%
6
10.7%
Moderate
1
1.8%
0
0%
0
0%
2
3.6%
Severe
0
0%
0
0%
0
0%
0
0%
Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Balanced Salt Solution (BSS), OMS302 Solution
Comments
Type of Statistical Test Superiority or Other
Comments
Statistical Test of Hypothesisp-Value0.528
CommentsTreatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.
MethodCochran-Mantel-Haenszel
Comments
Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection OMS302 Mydriatic Solution (PE), OMS302 Solution
Comments
Type of Statistical Test Superiority or Other
Comments
Statistical Test of Hypothesisp-Value0.362
CommentsTreatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.
MethodCochran-Mantel-Haenszel
Comments
Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection OMS302 Anti-inflammatory Solution (KE), OMS302 Solution
Comments
Type of Statistical Test Superiority or Other
Comments
Statistical Test of Hypothesisp-Value0.353
CommentsTreatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.
MethodCochran-Mantel-Haenszel
Comments
27. Secondary Outcome
TitleOcular Symptoms Using Numerical Rating System - Itching Two Days Post-Surgery
DescriptionThe ocular symptom outcomes were based on Ocular Pain and Symptoms Numerical Ordinal Scale (Numerical Rating System - NRS) at each time point for each assessment (tearing, photophobia, eye discharge, itching, foreign body sensation, and haziness). Treatment comparisons were performed using a Cochran-Mantel- Haenszel (CMH) test adjusting for the stratification factor LOCS II grade.
Time FrameTwo days

Outcome Measure Data

Analysis Population Description
Subjects with scores at time point.
Arm/Group TitleBalanced Salt Solution (BSS)OMS302 Mydriatic Solution (PE)OMS302 Anti-inflammatory Solution (KE)OMS302 Solution
Arm/Group DescriptionBalanced Salt Solution (BSS) Balanced Salt Solution (BSS)OMS302 Mydriatic Solution OMS302 Mydriatic SolutionOMS302 Anti-inflammatory Solution OMS302 Anti-inflammatory SolutionOMS302 Solution OMS302 Solution
Measure Participants56555555
None
45
78.9%
44
81.5%
46
83.6%
41
73.2%
Mild
11
19.3%
10
18.5%
9
16.4%
14
25%
Moderate
0
0%
1
1.9%
0
0%
0
0%
Severe
0
0%
0
0%
0
0%
0
0%
Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Balanced Salt Solution (BSS), OMS302 Solution
Comments
Type of Statistical Test Superiority or Other
Comments
Statistical Test of Hypothesisp-Value0.463
CommentsTreatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.
MethodCochran-Mantel-Haenszel
Comments
Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection OMS302 Mydriatic Solution (PE), OMS302 Solution
Comments
Type of Statistical Test Superiority or Other
Comments
Statistical Test of Hypothesisp-Value0.406
CommentsTreatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.
MethodCochran-Mantel-Haenszel
Comments
Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection OMS302 Anti-inflammatory Solution (KE), OMS302 Solution
Comments
Type of Statistical Test Superiority or Other
Comments
Statistical Test of Hypothesisp-Value0.245
CommentsTreatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.
MethodCochran-Mantel-Haenszel
Comments
28. Secondary Outcome
TitleOcular Symptoms Using Numerical Rating System - Itching Seven Days Post-Surgery
DescriptionThe ocular symptom outcomes were based on Ocular Pain and Symptoms Numerical Ordinal Scale (Numerical Rating System - NRS) at each time point for each assessment (tearing, photophobia, eye discharge, itching, foreign body sensation, and haziness). Treatment comparisons were performed using a Cochran-Mantel- Haenszel (CMH) test adjusting for the stratification factor LOCS II grade.
Time FrameSeven days

Outcome Measure Data

Analysis Population Description
Subjects with scores at time point.
Arm/Group TitleBalanced Salt Solution (BSS)OMS302 Mydriatic Solution (PE)OMS302 Anti-inflammatory Solution (KE)OMS302 Solution
Arm/Group DescriptionBalanced Salt Solution (BSS) Balanced Salt Solution (BSS)OMS302 Mydriatic Solution OMS302 Mydriatic SolutionOMS302 Anti-inflammatory Solution OMS302 Anti-inflammatory SolutionOMS302 Solution OMS302 Solution
Measure Participants53565355
None
39
68.4%
47
87%
40
72.7%
42
75%
Mild
13
22.8%
9
16.7%
13
23.6%
12
21.4%
Moderate
1
1.8%
0
0%
0
0%
1
1.8%
Severe
0
0%
0
0%
0
0%
0
0%
Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Balanced Salt Solution (BSS), OMS302 Solution
Comments
Type of Statistical Test Superiority or Other
Comments
Statistical Test of Hypothesisp-Value0.945
CommentsTreatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.
MethodCochran-Mantel-Haenszel
Comments
Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection OMS302 Mydriatic Solution (PE), OMS302 Solution
Comments
Type of Statistical Test Superiority or Other
Comments
Statistical Test of Hypothesisp-Value0.438
CommentsTreatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.
MethodCochran-Mantel-Haenszel
Comments
Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection OMS302 Anti-inflammatory Solution (KE), OMS302 Solution
Comments
Type of Statistical Test Superiority or Other
Comments
Statistical Test of Hypothesisp-Value0.596
CommentsTreatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.
MethodCochran-Mantel-Haenszel
Comments
29. Secondary Outcome
TitleOcular Symptoms Using Numerical Rating System - Itching 14 Days Post-Surgery
DescriptionThe ocular symptom outcomes were based on Ocular Pain and Symptoms Numerical Ordinal Scale (Numerical Rating System - NRS) at each time point for each assessment (tearing, photophobia, eye discharge, itching, foreign body sensation, and haziness). Treatment comparisons were performed using a Cochran-Mantel- Haenszel (CMH) test adjusting for the stratification factor LOCS II grade.
Time Frame14 days

Outcome Measure Data

Analysis Population Description
Subjects with scores at time point.
Arm/Group TitleBalanced Salt Solution (BSS)OMS302 Mydriatic Solution (PE)OMS302 Anti-inflammatory Solution (KE)OMS302 Solution
Arm/Group DescriptionBalanced Salt Solution (BSS) Balanced Salt Solution (BSS)OMS302 Mydriatic Solution OMS302 Mydriatic SolutionOMS302 Anti-inflammatory Solution OMS302 Anti-inflammatory SolutionOMS302 Solution OMS302 Solution
Measure Participants55555453
None
48
84.2%
45
83.3%
44
80%
44
78.6%
Mild
6
10.5%
10
18.5%
10
18.2%
8
14.3%
Moderate
1
1.8%
0
0%
0
0%
1
1.8%
Severe
0
0%
0
0%
0
0%
0
0%
Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Balanced Salt Solution (BSS), OMS302 Solution
Comments
Type of Statistical Test Superiority or Other
Comments
Statistical Test of Hypothesisp-Value0.811
CommentsTreatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.
MethodCochran-Mantel-Haenszel
Comments
Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection OMS302 Mydriatic Solution (PE), OMS302 Solution
Comments
Type of Statistical Test Superiority or Other
Comments
Statistical Test of Hypothesisp-Value0.552
CommentsTreatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.
MethodCochran-Mantel-Haenszel
Comments
Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection OMS302 Anti-inflammatory Solution (KE), OMS302 Solution
Comments
Type of Statistical Test Superiority or Other
Comments
Statistical Test of Hypothesisp-Value0.549
CommentsTreatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.
MethodCochran-Mantel-Haenszel
Comments
30. Secondary Outcome
TitleOcular Symptoms Using Numerical Rating System - Itching 30 Days Post-Surgery/Early Termination
DescriptionThe ocular symptom outcomes were based on Ocular Pain and Symptoms Numerical Ordinal Scale (Numerical Rating System - NRS) at each time point for each assessment (tearing, photophobia, eye discharge, itching, foreign body sensation, and haziness). Treatment comparisons were performed using a Cochran-Mantel- Haenszel (CMH) test adjusting for the stratification factor LOCS II grade.
Time FrameUp to 30 days

Outcome Measure Data

Analysis Population Description
Subjects with scores at time point.
Arm/Group TitleBalanced Salt Solution (BSS)OMS302 Mydriatic Solution (PE)OMS302 Anti-inflammatory Solution (KE)OMS302 Solution
Arm/Group DescriptionBalanced Salt Solution (BSS) Balanced Salt Solution (BSS)OMS302 Mydriatic Solution OMS302 Mydriatic SolutionOMS302 Anti-inflammatory Solution OMS302 Anti-inflammatory SolutionOMS302 Solution OMS302 Solution
Measure Participants55545453
None
43
75.4%
46
85.2%
47
85.5%
48
85.7%
Mild
11
19.3%
8
14.8%
7
12.7%
5
8.9%
Moderate
1
1.8%
0
0%
0
0%
0
0%
Severe
0
0%
0
0%
0
0%
0
0%
Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Balanced Salt Solution (BSS), OMS302 Solution
Comments
Type of Statistical Test Superiority or Other
Comments
Statistical Test of Hypothesisp-Value0.173
CommentsTreatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.
MethodCochran-Mantel-Haenszel
Comments
Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection OMS302 Mydriatic Solution (PE), OMS302 Solution
Comments
Type of Statistical Test Superiority or Other
Comments
Statistical Test of Hypothesisp-Value0.362
CommentsTreatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.
MethodCochran-Mantel-Haenszel
Comments
Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection OMS302 Anti-inflammatory Solution (KE), OMS302 Solution
Comments
Type of Statistical Test Superiority or Other
Comments
Statistical Test of Hypothesisp-Value0.559
Comments
MethodCochran-Mantel-Haenszel
Comments
31. Secondary Outcome
TitleOcular Symptoms Using Numerical Rating System - Foreign Body Sensation Two Hours Post-Surgery
DescriptionThe ocular symptom outcomes were based on Ocular Pain and Symptoms Numerical Ordinal Scale (Numerical Rating System - NRS) at each time point for each assessment (tearing, photophobia, eye discharge, itching, foreign body sensation, and haziness). Treatment comparisons were performed using a Cochran-Mantel- Haenszel (CMH) test adjusting for the stratification factor LOCS II grade.
Time FrameTwo hours

Outcome Measure Data

Analysis Population Description
Subjects with scores at time point.
Arm/Group TitleBalanced Salt Solution (BSS)OMS302 Mydriatic Solution (PE)OMS302 Anti-inflammatory Solution (KE)OMS302 Solution
Arm/Group DescriptionBalanced Salt Solution (BSS) Balanced Salt Solution (BSS)OMS302 Mydriatic Solution OMS302 Mydriatic SolutionOMS302 Anti-inflammatory Solution OMS302 Anti-inflammatory SolutionOMS302 Solution OMS302 Solution
Measure Participants56565554
None
32
56.1%
26
48.1%
31
56.4%
25
44.6%
Mild
17
29.8%
24
44.4%
20
36.4%
19
33.9%
Moderate
6
10.5%
4
7.4%
3
5.5%
9
16.1%
Severe
1
1.8%
2
3.7%
1
1.8%
1
1.8%
Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Balanced Salt Solution (BSS), OMS302 Solution
Comments
Type of Statistical Test Superiority or Other
Comments
Statistical Test of Hypothesisp-Value0.681
CommentsTreatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.
MethodCochran-Mantel-Haenszel
Comments
Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection OMS302 Mydriatic Solution (PE), OMS302 Solution
Comments
Type of Statistical Test Superiority or Other
Comments
Statistical Test of Hypothesisp-Value0.429
CommentsTreatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.
MethodCochran-Mantel-Haenszel
Comments
Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection OMS302 Anti-inflammatory Solution (KE), OMS302 Solution
Comments
Type of Statistical Test Superiority or Other
Comments
Statistical Test of Hypothesisp-Value0.306
CommentsTreatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.
MethodCochran-Mantel-Haenszel
Comments
32. Secondary Outcome
TitleOcular Symptoms Using Numerical Rating System - Foreign Body Sensation Six Hours Post-Surgery
DescriptionThe ocular symptom outcomes were based on Ocular Pain and Symptoms Numerical Ordinal Scale (Numerical Rating System - NRS) at each time point for each assessment (tearing, photophobia, eye discharge, itching, foreign body sensation, and haziness). Treatment comparisons were performed using a Cochran-Mantel- Haenszel (CMH) test adjusting for the stratification factor LOCS II grade.
Time FrameSix hours

Outcome Measure Data

Analysis Population Description
Subjects with scores at time point.
Arm/Group TitleBalanced Salt Solution (BSS) SolutionOMS302 Mydriatic Solution (PE)OMS302 Anti-inflammatory Solution (KE)OMS302 Solution
Arm/Group DescriptionBalanced Salt Solution (BSS) Solution Balanced Salt Solution (BSS) SolutionOMS302 Mydriatic Solution OMS302 Mydriatic SolutionOMS302 Anti-inflammatory Solution OMS302 Anti-inflammatory SolutionOMS302 Solution OMS302 Solution
Measure Participants54534950
None
26
45.6%
31
57.4%
31
56.4%
34
60.7%
Mild
19
33.3%
16
29.6%
16
29.1%
10
17.9%
Moderate
8
14%
4
7.4%
2
3.6%
5
8.9%
Severe
1
1.8%
2
3.7%
0
0%
1
1.8%
Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Balanced Salt Solution (BSS), OMS302 Solution
Comments
Type of Statistical Test Superiority or Other
Comments
Statistical Test of Hypothesisp-Value0.226
CommentsTreatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.
MethodCochran-Mantel-Haenszel
Comments
Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection OMS302 Mydriatic Solution (PE), OMS302 Solution
Comments
Type of Statistical Test Superiority or Other
Comments
Statistical Test of Hypothesisp-Value0.602
CommentsTreatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.
MethodCochran-Mantel-Haenszel
Comments
Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection OMS302 Anti-inflammatory Solution (KE), OMS302 Solution
Comments
Type of Statistical Test Superiority or Other
Comments
Statistical Test of Hypothesisp-Value0.290
Comments
MethodCochran-Mantel-Haenszel
Comments
33. Secondary Outcome
TitleOcular Symptoms Using Numerical Rating System - Foreign Body Sensation One Day Post-Surgery
DescriptionThe ocular symptom outcomes were based on Ocular Pain and Symptoms Numerical Ordinal Scale (Numerical Rating System - NRS) at each time point for each assessment (tearing, photophobia, eye discharge, itching, foreign body sensation, and haziness). Treatment comparisons were performed using a Cochran-Mantel- Haenszel (CMH) test adjusting for the stratification factor LOCS II grade.
Time FrameOne day

Outcome Measure Data

Analysis Population Description
Subjects with scores at time point.
Arm/Group TitleBalanced Salt Solution (BSS) SolutionOMS302 Mydriatic Solution (PE)OMS302 Anti-inflammatory Solution (KE)OMS302 Solution
Arm/Group DescriptionBalanced Salt Solution (BSS) Solution Balanced Salt Solution (BSS) SolutionOMS302 Mydriatic Solution OMS302 Mydriatic SolutionOMS302 Anti-inflammatory Solution OMS302 Anti-inflammatory SolutionOMS302 Solution OMS302 Solution
Measure Participants56555554
None
36
63.2%
25
46.3%
37
67.3%
35
62.5%
Mild
13
22.8%
25
46.3%
16
29.1%
16
28.6%
Moderate
7
12.3%
5
9.3%
2
3.6%
2
3.6%
Severe
0
0%
0
0%
0
0%
1
1.8%
Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Balanced Salt Solution (BSS), OMS302 Solution
Comments
Type of Statistical Test Superiority or Other
Comments
Statistical Test of Hypothesisp-Value0.244
CommentsTreatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.
MethodCochran-Mantel-Haenszel
Comments
Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection OMS302 Mydriatic Solution (PE), OMS302 Solution
Comments
Type of Statistical Test Superiority or Other
Comments
Statistical Test of Hypothesisp-Value0.122
CommentsTreatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.
MethodCochran-Mantel-Haenszel
Comments
Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection OMS302 Anti-inflammatory Solution (KE), OMS302 Solution
Comments
Type of Statistical Test Superiority or Other
Comments
Statistical Test of Hypothesisp-Value0.790
CommentsTreatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.
MethodCochran-Mantel-Haenszel
Comments
34. Secondary Outcome
TitleOcular Symptoms Using Numerical Rating System - Foreign Body Sensation Two Days Post-Surgery
DescriptionThe ocular symptom outcomes were based on Ocular Pain and Symptoms Numerical Ordinal Scale (Numerical Rating System - NRS) at each time point for each assessment (tearing, photophobia, eye discharge, itching, foreign body sensation, and haziness). Treatment comparisons were performed using a Cochran-Mantel- Haenszel (CMH) test adjusting for the stratification factor LOCS II grade.
Time FrameTwo days

Outcome Measure Data

Analysis Population Description
Subjects with scores at time point.
Arm/Group TitleBalanced Salt Solution (BSS)OMS302 Mydriatic Solution (PE)OMS302 Anti-inflammatory Solution (KE)OMS302 Solution
Arm/Group DescriptionBalanced Salt Solution (BSS) Balanced Salt Solution (BSS)OMS302 Mydriatic Solution OMS302 Mydriatic SolutionOMS302 Anti-inflammatory Solution OMS302 Anti-inflammatory SolutionOMS302 Solution OMS302 Solution
Measure Participants56555555
None
37
64.9%
39
72.2%
38
69.1%
35
62.5%
Mild
16
28.1%
11
20.4%
15
27.3%
15
26.8%
Moderate
3
5.3%
3
5.6%
1
1.8%
5
8.9%
Severe
0
0%
2
3.7%
1
1.8%
0
0%
Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Balanced Salt Solution (BSS), OMS302 Solution
Comments
Type of Statistical Test Superiority or Other
Comments
Statistical Test of Hypothesisp-Value0.752
CommentsTreatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.
MethodCochran-Mantel-Haenszel
Comments
Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection OMS302 Mydriatic Solution (PE), OMS302 Solution
Comments
Type of Statistical Test Superiority or Other
Comments
Statistical Test of Hypothesisp-Value0.355
CommentsTreatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.
MethodCochran-Mantel-Haenszel
Comments
Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection OMS302 Anti-inflammatory Solution (KE), OMS302 Solution
Comments
Type of Statistical Test Superiority or Other
Comments
Statistical Test of Hypothesisp-Value0.292
CommentsTreatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.
MethodCochran-Mantel-Haenszel
Comments
35. Secondary Outcome
TitleOcular Symptoms Using Numerical Rating System - Foreign Body Sensation Seven Days Post-Surgery 7 Days
DescriptionThe ocular symptom outcomes were based on Ocular Pain and Symptoms Numerical Ordinal Scale (Numerical Rating System - NRS) at each time point for each assessment (tearing, photophobia, eye discharge, itching, foreign body sensation, and haziness). Treatment comparisons were performed using a Cochran-Mantel- Haenszel (CMH) test adjusting for the stratification factor LOCS II grade.
Time FrameSeven days

Outcome Measure Data

Analysis Population Description
Subjects with scores at time point.
Arm/Group TitleBalanced Salt Solution (BSS)OMS302 Mydriatic Solution (PE)OMS302 Anti-inflammatory Solution (KE)OMS302 Solution
Arm/Group DescriptionBalanced Salt Solution (BSS) Balanced Salt Solution (BSS)OMS302 Mydriatic Solution OMS302 Mydriatic SolutionOMS302 Anti-inflammatory Solution OMS302 Anti-inflammatory SolutionOMS302 Solution OMS302 Solution
Measure Participants53565355
None
27
47.4%
32
59.3%
34
61.8%
37
66.1%
Mild
23
40.4%
17
31.5%
17
30.9%
15
26.8%
Moderate
3
5.3%
5
9.3%
2
3.6%
2
3.6%
Severe
0
0%
2
3.7%
0
0%
1
1.8%
Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Balanced Salt Solution (BSS), OMS302 Solution
Comments
Type of Statistical Test Superiority or Other
Comments
Statistical Test of Hypothesisp-Value0.228
CommentsTreatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.
MethodCochran-Mantel-Haenszel
Comments
Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection OMS302 Mydriatic Solution (PE), OMS302 Solution
Comments
Type of Statistical Test Superiority or Other
Comments
Statistical Test of Hypothesisp-Value0.564
CommentsTreatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.
MethodCochran-Mantel-Haenszel
Comments
Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection OMS302 Anti-inflammatory Solution (KE), OMS302 Solution
Comments
Type of Statistical Test Superiority or Other
Comments
Statistical Test of Hypothesisp-Value0.755
CommentsTreatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.
MethodCochran-Mantel-Haenszel
Comments
36. Secondary Outcome
TitleOcular Symptoms Using Numerical Rating System - Foreign Body Sensation 14 Days Post-Surgery
DescriptionThe ocular symptom outcomes were based on Ocular Pain and Symptoms Numerical Ordinal Scale (Numerical Rating System - NRS) at each time point for each assessment (tearing, photophobia, eye discharge, itching, foreign body sensation, and haziness). Treatment comparisons were performed using a Cochran-Mantel- Haenszel (CMH) test adjusting for the stratification factor LOCS II grade.
Time Frame14 days

Outcome Measure Data

Analysis Population Description
Subjects with scores at time point.
Arm/Group TitleBalanced Salt Solution (BSS)OMS302 Mydriatic Solution (PE)OMS302 Anti-inflammatory Solution (KE)OMS302 Solution
Arm/Group DescriptionBalanced Salt Solution (BSS) Balanced Salt Solution (BSS)OMS302 Mydriatic Solution OMS302 Mydriatic SolutionOMS302 Anti-inflammatory Solution OMS302 Anti-inflammatory SolutionOMS302 Solution OMS302 Solution
Measure Participants55555453
None
31
54.4%
38
70.4%
36
65.5%
42
75%
Mild
23
40.4%
16
29.6%
16
29.1%
9
16.1%
Moderate
1
1.8%
1
1.9%
1
1.8%
2
3.6%
Severe
0
0%
0
0%
1
1.8%
0
0%
Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Balanced Salt Solution (BSS), OMS302 Solution
Comments
Type of Statistical Test Superiority or Other
Comments
Statistical Test of Hypothesisp-Value0.018
CommentsTreatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.
MethodCochran-Mantel-Haenszel
Comments
Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection OMS302 Mydriatic Solution (PE), OMS302 Solution
Comments
Type of Statistical Test Superiority or Other
Comments
Statistical Test of Hypothesisp-Value0.292
CommentsTreatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.
MethodCochran-Mantel-Haenszel
Comments
Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection OMS302 Anti-inflammatory Solution (KE), OMS302 Solution
Comments
Type of Statistical Test Superiority or Other
Comments
Statistical Test of Hypothesisp-Value0.298
CommentsTreatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.
MethodCochran-Mantel-Haenszel
Comments
37. Secondary Outcome
TitleOcular Symptoms Using Numerical Rating System - Foreign Body Sensation 30 Days Post-Surgery/Early Termination
DescriptionThe ocular symptom outcomes were based on Ocular Pain and Symptoms Numerical Ordinal Scale (Numerical Rating System - NRS) at each time point for each assessment (tearing, photophobia, eye discharge, itching, foreign body sensation, and haziness). Treatment comparisons were performed using a Cochran-Mantel- Haenszel (CMH) test adjusting for the stratification factor LOCS II grade.
Time FrameUp to 30 days

Outcome Measure Data

Analysis Population Description
Subjects with scores at time point.
Arm/Group TitleBalanced Salt Solution (BSS)OMS302 Mydriatic Solution (PE)OMS302 Anti-inflammatory Solution (KE)OMS302 Solution
Arm/Group DescriptionBalanced Salt Solution (BSS) Balanced Salt Solution (BSS)OMS302 Mydriatic Solution OMS302 Mydriatic SolutionOMS302 Anti-inflammatory Solution OMS302 Anti-inflammatory SolutionOMS302 Solution OMS302 Solution
Measure Participants55545453
None
41
71.9%
44
81.5%
40
72.7%
46
82.1%
Mild
12
21.1%
10
18.5%
14
25.5%
6
10.7%
Moderate
2
3.5%
0
0%
0
0%
1
1.8%
Severe
0
0%
0
0%
0
0%
0
0%
Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Balanced Salt Solution (BSS), OMS302 Solution
Comments
Type of Statistical Test Superiority or Other
Comments
Statistical Test of Hypothesisp-Value0.271
CommentsTreatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.
MethodCochran-Mantel-Haenszel
Comments
Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection OMS302 Mydriatic Solution (PE), OMS302 Solution
Comments
Type of Statistical Test Superiority or Other
Comments
Statistical Test of Hypothesisp-Value0.345
CommentsTreatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.
MethodCochran-Mantel-Haenszel
Comments
Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection OMS302 Anti-inflammatory Solution (KE), OMS302 Solution
Comments
Type of Statistical Test Superiority or Other
Comments
Statistical Test of Hypothesisp-Value0.096
CommentsTreatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.
MethodCochran-Mantel-Haenszel
Comments
38. Secondary Outcome
TitleOcular Symptoms Using Numerical Rating System - Haziness Two Hours Post-Surgery
DescriptionThe ocular symptom outcomes were based on Ocular Pain and Symptoms Numerical Ordinal Scale (Numerical Rating System - NRS) at each time point for each assessment (tearing, photophobia, eye discharge, itching, foreign body sensation, and haziness). Treatment comparisons were performed using a Cochran-Mantel- Haenszel (CMH) test adjusting for the stratification factor LOCS II grade.
Time FrameTwo hours

Outcome Measure Data

Analysis Population Description
Subjects with scores at time point.
Arm/Group TitleBalanced Salt Solution (BSS)OMS302 Mydriatic Solution (PE)OMS302 Anti-inflammatory Solution (KE)OMS302 Solution
Arm/Group DescriptionBalanced Salt Solution (BSS) Balanced Salt Solution (BSS)OMS302 Mydriatic Solution OMS302 Mydriatic SolutionOMS302 Anti-inflammatory Solution OMS302 Anti-inflammatory SolutionOMS302 Solution OMS302 Solution
Measure Participants56565554
None
27
47.4%
24
44.4%
28
50.9%
17
30.4%
Mild
21
36.8%
17
31.5%
18
32.7%
25
44.6%
Moderate
6
10.5%
12
22.2%
8
14.5%
10
17.9%
Severe
2
3.5%
3
5.6%
1
1.8%
2
3.6%
Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Balanced Salt Solution (BSS), OMS302 Solution
Comments
Type of Statistical Test Superiority or Other
Comments
Statistical Test of Hypothesisp-Value0.320
CommentsTreatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.
MethodCochran-Mantel-Haenszel
Comments
Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection OMS302 Mydriatic Solution (PE), OMS302 Solution
Comments
Type of Statistical Test Superiority or Other
Comments
Statistical Test of Hypothesisp-Value0.390
CommentsTreatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.
MethodCochran-Mantel-Haenszel
Comments
Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection OMS302 Anti-inflammatory Solution (KE), OMS302 Solution
Comments
Type of Statistical Test Superiority or Other
Comments
Statistical Test of Hypothesisp-Value0.230
CommentsTreatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.
MethodCochran-Mantel-Haenszel
Comments
39. Secondary Outcome
TitleOcular Symptoms Using Numerical Rating System - Haziness Six Hours Post-Surgery
DescriptionThe ocular symptom outcomes were based on Ocular Pain and Symptoms Numerical Ordinal Scale (Numerical Rating System - NRS) at each time point for each assessment (tearing, photophobia, eye discharge, itching, foreign body sensation, and haziness). Treatment comparisons were performed using a Cochran-Mantel- Haenszel (CMH) test adjusting for the stratification factor LOCS II grade.
Time FrameSix hours

Outcome Measure Data

Analysis Population Description
Subjects with scores at time point.
Arm/Group TitleBalanced Salt Solution (BSS)OMS302 Mydriatic Solution (PE)OMS302 Anti-inflammatory Solution (KE)OMS302 Solution
Arm/Group DescriptionBalanced Salt Solution (BSS) Balanced Salt Solution (BSS)OMS302 Mydriatic Solution OMS302 Mydriatic SolutionOMS302 Anti-inflammatory Solution OMS302 Anti-inflammatory SolutionOMS302 Solution OMS302 Solution
Measure Participants53534950
None
24
42.1%
20
37%
26
47.3%
23
41.1%
Mild
21
36.8%
20
37%
13
23.6%
19
33.9%
Moderate
7
12.3%
10
18.5%
10
18.2%
8
14.3%
Severe
1
1.8%
3
5.6%
0
0%
0
0%
Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Balanced Salt Solution (BSS), OMS302 Solution
Comments
Type of Statistical Test Superiority or Other
Comments
Statistical Test of Hypothesisp-Value0.778
CommentsTreatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.
MethodCochran-Mantel-Haenszel
Comments
Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection OMS302 Mydriatic Solution (PE), OMS302 Solution
Comments
Type of Statistical Test Superiority or Other
Comments
Statistical Test of Hypothesisp-Value0.348
CommentsTreatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.
MethodCochran-Mantel-Haenszel
Comments
Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection OMS302 Anti-inflammatory Solution (KE), OMS302 Solution
Comments
Type of Statistical Test Superiority or Other
Comments
Statistical Test of Hypothesisp-Value0.477
CommentsTreatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.
MethodCochran-Mantel-Haenszel
Comments
40. Secondary Outcome
TitleOcular Symptoms Using Numerical Rating System - Haziness One Day Post-Surgery
DescriptionThe ocular symptom outcomes were based on Ocular Pain and Symptoms Numerical Ordinal Scale (Numerical Rating System - NRS) at each time point for each assessment (tearing, photophobia, eye discharge, itching, foreign body sensation, and haziness). Treatment comparisons were performed using a Cochran-Mantel- Haenszel (CMH) test adjusting for the stratification factor LOCS II grade.
Time FrameOne day

Outcome Measure Data

Analysis Population Description
Subjects with scores at time point.
Arm/Group TitleBalanced Salt Solution (BSS)OMS302 Mydriatic Solution (PE)OMS302 Anti-inflammatory Solution (KE)OMS302 Solution
Arm/Group DescriptionBalanced Salt Solution (BSS) Balanced Salt Solution (BSS)OMS302 Mydriatic Solution OMS302 Mydriatic SolutionOMS302 Anti-inflammatory Solution OMS302 Anti-inflammatory SolutionOMS302 Solution OMS302 Solution
Measure Participants56555554
None
34
59.6%
29
53.7%
36
65.5%
38
67.9%
Mild
15
26.3%
19
35.2%
17
30.9%
12
21.4%
Moderate
7
12.3%
4
7.4%
2
3.6%
3
5.4%
Severe
0
0%
3
5.6%
0
0%
1
1.8%
Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Balanced Salt Solution (BSS), OMS302 Solution
Comments
Type of Statistical Test Superiority or Other
Comments
Statistical Test of Hypothesisp-Value0.374
CommentsTreatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.
MethodCochran-Mantel-Haenszel
Comments
Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection OMS302 Mydriatic Solution (PE), OMS302 Solution
Comments
Type of Statistical Test Superiority or Other
Comments
Statistical Test of Hypothesisp-Value0.265
CommentsTreatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.
MethodCochran-Mantel-Haenszel
Comments
Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection OMS302 Anti-inflammatory Solution (KE), OMS302 Solution
Comments
Type of Statistical Test Superiority or Other
Comments
Statistical Test of Hypothesisp-Value0.555
CommentsTreatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.
MethodCochran-Mantel-Haenszel
Comments
41. Secondary Outcome
TitleOcular Symptoms Using Numerical Rating System - Haziness Two Days Post-Surgery
DescriptionThe ocular symptom outcomes were based on Ocular Pain and Symptoms Numerical Ordinal Scale (Numerical Rating System - NRS) at each time point for each assessment (tearing, photophobia, eye discharge, itching, foreign body sensation, and haziness). Treatment comparisons were performed using a Cochran-Mantel- Haenszel (CMH) test adjusting for the stratification factor LOCS II grade.
Time FrameTwo days

Outcome Measure Data

Analysis Population Description
Subjects with scores at time point.
Arm/Group TitleBalanced Salt Solution (BSS)OMS302 Mydriatic Solution (PE)OMS302 Anti-inflammatory Solution (KE)OMS302 Solution
Arm/Group DescriptionBalanced Salt Solution (BSS) Balanced Salt Solution (BSS)OMS302 Mydriatic Solution OMS302 Mydriatic SolutionOMS302 Anti-inflammatory Solution OMS302 Anti-inflammatory SolutionOMS302 Solution OMS302 Solution
Measure Participants56555555
None
36
63.2%
31
57.4%
39
70.9%
43
76.8%
Mild
19
33.3%
17
31.5%
13
23.6%
8
14.3%
Moderate
1
1.8%
5
9.3%
3
5.5%
4
7.1%
Severe
0
0%
2
3.7%
0
0%
0
0%
Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Balanced Salt Solution (BSS), OMS302 Solution
Comments
Type of Statistical Test Superiority or Other
Comments
Statistical Test of Hypothesisp-Value0.031
CommentsTreatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.
MethodCochran-Mantel-Haenszel
Comments
Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection OMS302 Mydriatic Solution (PE), OMS302 Solution
Comments
Type of Statistical Test Superiority or Other
Comments
Statistical Test of Hypothesisp-Value0.059
CommentsTreatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.
MethodCochran-Mantel-Haenszel
Comments
Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection OMS302 Anti-inflammatory Solution (KE), OMS302 Solution
Comments
Type of Statistical Test Superiority or Other
Comments
Statistical Test of Hypothesisp-Value0.472
CommentsTreatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.
MethodCochran-Mantel-Haenszel
Comments
42. Secondary Outcome
TitleOcular Symptoms Using Numerical Rating System - Haziness Seven Days Post-Surgery
DescriptionThe ocular symptom outcomes were based on Ocular Pain and Symptoms Numerical Ordinal Scale (Numerical Rating System - NRS) at each time point for each assessment (tearing, photophobia, eye discharge, itching, foreign body sensation, and haziness). Treatment comparisons were performed using a Cochran-Mantel- Haenszel (CMH) test adjusting for the stratification factor LOCS II grade.
Time FrameSeven days

Outcome Measure Data

Analysis Population Description
Subjects with scores at time point.
Arm/Group TitleBalanced Salt Solution (BSS)OMS302 Mydriatic Solution (PE)OMS302 Anti-inflammatory Solution (KE)OMS302 Solution
Arm/Group DescriptionBalanced Salt Solution (BSS) Balanced Salt Solution (BSS)OMS302 Mydriatic Solution OMS302 Mydriatic SolutionOMS302 Anti-inflammatory Solution OMS302 Anti-inflammatory SolutionOMS302 Solution OMS302 Solution
Measure Participants53565355
None
36
63.2%
33
61.1%
34
61.8%
41
73.2%
Mild
16
28.1%
17
31.5%
18
32.7%
11
19.6%
Moderate
1
1.8%
6
11.1%
1
1.8%
2
3.6%
Severe
0
0%
0
0%
0
0%
1
1.8%
Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Balanced Salt Solution (BSS), OMS302 Solution
Comments
Type of Statistical Test Superiority or Other
Comments
Statistical Test of Hypothesisp-Value0.476
CommentsTreatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.
MethodCochran-Mantel-Haenszel
Comments
Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection OMS302 Mydriatic Solution (PE), OMS302 Solution
Comments
Type of Statistical Test Superiority or Other
Comments
Statistical Test of Hypothesisp-Value0.169
CommentsTreatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.
MethodCochran-Mantel-Haenszel
Comments
Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection OMS302 Anti-inflammatory Solution (KE), OMS302 Solution
Comments
Type of Statistical Test Superiority or Other
Comments
Statistical Test of Hypothesisp-Value0.310
CommentsTreatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.
MethodCochran-Mantel-Haenszel
Comments
43. Secondary Outcome
TitleOcular Symptoms Using Numerical Rating System - Haziness 14 Days Post-Surgery
DescriptionThe ocular symptom outcomes were based on Ocular Pain and Symptoms Numerical Ordinal Scale (Numerical Rating System - NRS) at each time point for each assessment (tearing, photophobia, eye discharge, itching, foreign body sensation, and haziness). Treatment comparisons were performed using a Cochran-Mantel- Haenszel (CMH) test adjusting for the stratification factor LOCS II grade.
Time Frame14 days

Outcome Measure Data

Analysis Population Description
Subjects with scores at time point.
Arm/Group TitleBalanced Salt Solution (BSS)OMS302 Mydriatic Solution (PE)OMS302 Anti-inflammatory Solution (KE)OMS302 Solution
Arm/Group DescriptionBalanced Salt Solution (BSS) Balanced Salt Solution (BSS)OMS302 Mydriatic Solution OMS302 Mydriatic SolutionOMS302 Anti-inflammatory Solution OMS302 Anti-inflammatory SolutionOMS302 Solution OMS302 Solution
Measure Participants55555453
None
39
68.4%
34
63%
39
70.9%
47
83.9%
Mild
10
17.5%
16
29.6%
13
23.6%
4
7.1%
Moderate
6
10.5%
5
9.3%
1
1.8%
2
3.6%
Severe
0
0%
0
0%
1
1.8%
0
0%
Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Balanced Salt Solution (BSS), OMS302 Solution
Comments
Type of Statistical Test Superiority or Other
Comments
Statistical Test of Hypothesisp-Value0.075
CommentsTreatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.
MethodCochran-Mantel-Haenszel
Comments
Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection OMS302 Mydriatic Solution (PE), OMS302 Solution
Comments
Type of Statistical Test Superiority or Other
Comments
Statistical Test of Hypothesisp-Value0.005
CommentsTreatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.
MethodCochran-Mantel-Haenszel
Comments
Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection OMS302 Anti-inflammatory Solution (KE), OMS302 Solution
Comments
Type of Statistical Test Superiority or Other
Comments
Statistical Test of Hypothesisp-Value0.078
CommentsTreatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.
MethodCochran-Mantel-Haenszel
Comments
44. Secondary Outcome
TitleOcular Symptoms Using Numerical Rating System - Haziness 30 Days Post-Surgery/Early Termination
DescriptionThe ocular symptom outcomes were based on Ocular Pain and Symptoms Numerical Ordinal Scale (Numerical Rating System - NRS) at each time point for each assessment (tearing, photophobia, eye discharge, itching, foreign body sensation, and haziness). Treatment comparisons were performed using a Cochran-Mantel- Haenszel (CMH) test adjusting for the stratification factor LOCS II grade.
Time FrameUp to 30 days

Outcome Measure Data

Analysis Population Description
Subjects with scores at time point.
Arm/Group TitleBalanced Salt Solution (BSS)OMS302 Mydriatic Solution (PE)OMS302 Anti-inflammatory Solution (KE)OMS302 Solution
Arm/Group DescriptionBalanced Salt Solution (BSS) Balanced Salt Solution (BSS)OMS302 Mydriatic Solution OMS302 Mydriatic SolutionOMS302 Anti-inflammatory Solution OMS302 Anti-inflammatory SolutionOMS302 Solution OMS302 Solution
Measure Participants55545453
None
38
66.7%
42
77.8%
44
80%
44
78.6%
Mild
14
24.6%
6
11.1%
10
18.2%
7
12.5%
Moderate
3
5.3%
6
11.1%
0
0%
2
3.6%
Severe
0
0%
0
0%
0
0%
0
0%
Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Balanced Salt Solution (BSS), OMS302 Solution
Comments
Type of Statistical Test Superiority or Other
Comments
Statistical Test of Hypothesisp-Value0.226
CommentsTreatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.
MethodCochran-Mantel-Haenszel
Comments
Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection OMS302 Mydriatic Solution (PE), OMS302 Solution
Comments
Type of Statistical Test Superiority or Other
Comments
Statistical Test of Hypothesisp-Value0.357
CommentsTreatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.
MethodCochran-Mantel-Haenszel
Comments
Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection OMS302 Anti-inflammatory Solution (KE), OMS302 Solution
Comments
Type of Statistical Test Superiority or Other
Comments
Statistical Test of Hypothesisp-Value0.291
CommentsTreatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.
MethodCochran-Mantel-Haenszel
Comments
45. Secondary Outcome
TitleBest Corrected Visual Acuity (BVCA) - Log Score, Baseline
DescriptionBest-Corrected Visual Acuity (BCVA) was summarized by the Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity log score. For subjects without a score due to inability to read the ETDRS chart, the log score was imputed as 1.6 for the purpose of treatment comparisons. Subjects without a score because the manifest refraction was not completed were excluded from the analysis. Treatment comparisons for BCVA were performed by pairwise Wilcoxon tests.
Time FrameBaseline

Outcome Measure Data

Analysis Population Description
Subjects with scores at time point.
Arm/Group TitleBalanced Salt Solution (BSS)OMS302 Mydriatic Solution (PE)OMS302 Anti-inflammatory Solution (KE)OMS302 Solution
Arm/Group DescriptionBalanced Salt Solution (BSS) Balanced Salt Solution (BSS)OMS302 Mydriatic Solution OMS302 Mydriatic SolutionOMS302 Anti-inflammatory Solution OMS302 Anti-inflammatory SolutionOMS302 Solution OMS302 Solution
Measure Participants54555356
Mean (Standard Deviation) [Log score]
0.4
(0.3)
0.4
(0.2)
0.4
(0.2)
0.4
(0.3)
Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Balanced Salt Solution (BSS), OMS302 Solution
Comments
Type of Statistical Test Superiority or Other
Comments
Statistical Test of Hypothesisp-Value0.172
CommentsTreatment comparisons between OMS302 and each of the other three groups are based on Wilcoxon rank-sum test.
MethodWilcoxon rank-sum test
Comments
Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection OMS302 Mydriatic Solution (PE), OMS302 Solution
Comments
Type of Statistical Test Superiority or Other
Comments
Statistical Test of Hypothesisp-Value0.547
CommentsTreatment comparisons between OMS302 and each of the other three groups are based on Wilcoxon rank-sum test.
MethodWilcoxon rank-sum test
Comments
Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection OMS302 Anti-inflammatory Solution (KE), OMS302 Solution
Comments
Type of Statistical Test Superiority or Other
Comments
Statistical Test of Hypothesisp-Value0.921
CommentsTreatment comparisons between OMS302 and each of the other three groups are based on Wilcoxon rank-sum test.
MethodWicoxon rank-sum test
Comments
46. Secondary Outcome
TitleBest Corrected Visual Acuity (BVCA) - Log Score, Day 1
DescriptionBest-Corrected Visual Acuity (BCVA) was summarized by the ETDRS visual acuity log score. For subjects without a score due to inability to read the ETDRS chart, the log score was imputed as 1.6 for the purpose of treatment comparisons. Subjects without a score because the manifest refraction was not completed were excluded from the analysis. Treatment comparisons for BCVA were performed by pairwise Wilcoxon tests.
Time FrameOne day

Outcome Measure Data

Analysis Population Description
Subjects with scores at time point.
Arm/Group TitleBalanced Salt Solution (BSS)OMS302 Mydriatic Solution (PE)OMS302 Anti-inflammatory Solution (KE)OMS302 Solution
Arm/Group DescriptionBalanced Salt Solution (BSS) Balanced Salt Solution (BSS)OMS302 Mydriatic Solution OMS302 Mydriatic SolutionOMS302 Anti-inflammatory Solution OMS302 Anti-inflammatory SolutionOMS302 Solution OMS302 Solution
Measure Participants56555554
Mean (Standard Deviation) [Log score]
0.1
(0.2)
0.2
(0.3)
0.2
(0.2)
0.1
(0.2)
Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Balanced Salt Solution (BSS), OMS302 Solution
Comments
Type of Statistical Test Superiority or Other
Comments
Statistical Test of Hypothesisp-Value0.701
CommentsTreatment comparisons between OMS302 and each of the other three groups are based on Wilcoxon rank-sum test.
MethodWilcoxon rank-sum test
Comments
Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection OMS302 Mydriatic Solution (PE), OMS302 Solution
Comments
Type of Statistical Test Superiority or Other
Comments
Statistical Test of Hypothesisp-Value0.089
CommentsTreatment comparisons between OMS302 and each of the other three groups are based on Wilcoxon rank-sum test.
MethodWilcoxon rank-sum test
Comments
Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection OMS302 Anti-inflammatory Solution (KE), OMS302 Solution
Comments
Type of Statistical Test Superiority or Other
Comments
Statistical Test of Hypothesisp-Value0.095
CommentsTreatment comparisons between OMS302 and each of the other three groups are based on Wilcoxon rank-sum test.
MethodWilcoxon rank-sum test
Comments
47. Secondary Outcome
TitleBest Corrected Visual Acuity (BVCA) - Log Score, Day 2
DescriptionBest-Corrected Visual Acuity (BCVA) was summarized by the ETDRS visual acuity log score. For subjects without a score due to inability to read the ETDRS chart, the log score was imputed as 1.6 for the purpose of treatment comparisons. Subjects without a score because the manifest refraction was not completed were excluded from the analysis. Treatment comparisons for BCVA were performed by pairwise Wilcoxon tests.
Time FrameTwo days

Outcome Measure Data

Analysis Population Description
Subjects with scores at time point.
Arm/Group TitleBalanced Salt Solution (BSS)OMS302 Mydriatic Solution (PE)OMS302 Anti-inflammatory Solution (KE)OMS302 Solution
Arm/Group DescriptionBalanced Salt Solution (BSS) Balanced Salt Solution (BSS)OMS302 Mydriatic Solution OMS302 Mydriatic SolutionOMS302 Anti-inflammatory Solution OMS302 Anti-inflammatory SolutionOMS302 Solution OMS302 Solution
Measure Participants56565555
Mean (Standard Deviation) [Log score]
0.1
(0.2)
0.2
(0.3)
0.1
(0.2)
0.1
(0.1)
Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Balanced Salt Solution (BSS), OMS302 Solution
Comments
Type of Statistical Test Superiority or Other
Comments
Statistical Test of Hypothesisp-Value0.086
CommentsTreatment comparisons between OMS302 and each of the other three groups are based on Wilcoxon rank-sum test.
MethodWilcoxon rank-sum test
Comments
Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection OMS302 Mydriatic Solution (PE), OMS302 Solution
Comments
Type of Statistical Test Superiority or Other
Comments
Statistical Test of Hypothesisp-Value0.092
CommentsTreatment comparisons between OMS302 and each of the other three groups are based on Wilcoxon rank-sum test.
MethodWicoxon rank-sum test
Comments
Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection OMS302 Anti-inflammatory Solution (KE), OMS302 Solution
Comments
Type of Statistical Test Superiority or Other
Comments
Statistical Test of Hypothesisp-Value0.120
CommentsTreatment comparisons between OMS302 and each of the other three groups are based on Wilcoxon rank-sum test.
MethodWilcoxon rank-sum test
Comments
48. Secondary Outcome
TitleBest Corrected Visual Acuity (BVCA) - Log Score, Day 7
DescriptionBest-Corrected Visual Acuity (BCVA) was summarized by the ETDRS visual acuity log score. For subjects without a score due to inability to read the ETDRS chart, the log score was imputed as 1.6 for the purpose of treatment comparisons. Subjects without a score because the manifest refraction was not completed were excluded from the analysis. Treatment comparisons for BCVA were performed by pairwise Wilcoxon tests.
Time FrameSeven days

Outcome Measure Data

Analysis Population Description
Subjects with scores at time point.
Arm/Group TitleBalanced Salt Solution (BSS)OMS302 Mydriatic Solution (PE)OMS302 Anti-inflammatory Solution (KE)OMS302 Solution
Arm/Group DescriptionBalanced Salt Solution (BSS) Balanced Salt Solution (BSS)OMS302 Mydriatic Solution OMS302 Mydriatic SolutionOMS302 Anti-inflammatory Solution OMS302 Anti-inflammatory SolutionOMS302 Solution OMS302 Solution
Measure Participants56565355
Mean (Standard Deviation) [Log score]
0.1
(0.2)
0.1
(0.2)
0.1
(0.1)
0.1
(0.2)
Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Balanced Salt Solution (BSS), OMS302 Solution
Comments
Type of Statistical Test Superiority or Other
Comments
Statistical Test of Hypothesisp-Value0.626
CommentsTreatment comparisons between OMS302 and each of the other three groups are based on Wilcoxon rank-sum test.
MethodWilcoxon rank-sum test
Comments
Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection OMS302 Mydriatic Solution (PE), OMS302 Solution
Comments
Type of Statistical Test Superiority or Other
Comments
Statistical Test of Hypothesisp-Value0.736
CommentsTreatment comparisons between OMS302 and each of the other three groups are based on Wilcoxon rank-sum test.
MethodWilcoxon rank-sum test
Comments
Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection OMS302 Anti-inflammatory Solution (KE), OMS302 Solution
Comments
Type of Statistical Test Superiority or Other
Comments
Statistical Test of Hypothesisp-Value0.725
CommentsTreatment comparisons between OMS302 and each of the other three groups are based on Wilcoxon rank-sum test.
MethodWilcoxon rank-sum test
Comments
49. Secondary Outcome
TitleBest Corrected Visual Acuity (BVCA) - Log Score, Day 14
DescriptionBest-Corrected Visual Acuity (BCVA) was summarized by the ETDRS visual acuity log score. For subjects without a score due to inability to read the ETDRS chart, the log score was imputed as 1.6 for the purpose of treatment comparisons. Subjects without a score because the manifest refraction was not completed were excluded from the analysis. Treatment comparisons for BCVA were performed by pairwise Wilcoxon tests.
Time Frame14 days

Outcome Measure Data

Analysis Population Description
Subjects with scores at time point.
Arm/Group TitleBalanced Salt Solution (BSS)OMS302 Mydriatic Solution (PE)OMS302 Anti-inflammatory Solution (KE)OMS302 Solution
Arm/Group DescriptionBalanced Salt Solution (BSS) Balanced Salt Solution (BSS)OMS302 Mydriatic Solution OMS302 Mydriatic SolutionOMS302 Anti-inflammatory Solution OMS302 Anti-inflammatory SolutionOMS302 Solution OMS302 Solution
Measure Participants55565553
Mean (Standard Deviation) [Log score]
0.1
(0.2)
0.1
(0.2)
0.1
(0.2)
0.1
(0.1)
Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Balanced Salt Solution (BSS), OMS302 Solution
Comments
Type of Statistical Test Superiority or Other
Comments
Statistical Test of Hypothesisp-Value0.220
CommentsTreatment comparisons between OMS302 and each of the other three groups are based on Wilcoxon rank-sum test.
MethodWilcoxon rank-sum test
Comments
Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection OMS302 Mydriatic Solution (PE), OMS302 Solution
Comments
Type of Statistical Test Superiority or Other
Comments
Statistical Test of Hypothesisp-Value0.903
CommentsTreatment comparisons between OMS302 and each of the other three groups are based on Wilcoxon rank-sum test.
MethodWilcoxon rank-sum test
Comments
Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection OMS302 Anti-inflammatory Solution (KE), OMS302 Solution
Comments
Type of Statistical Test Superiority or Other
Comments
Statistical Test of Hypothesisp-Value0.463
CommentsTreatment comparisons between OMS302 and each of the other three groups are based on Wilcoxon rank-sum test.
MethodWilcoxon rank-sum test
Comments
50. Secondary Outcome
TitleBest Corrected Visual Acuity (BVCA) - Log Score, Day 30
DescriptionBest-Corrected Visual Acuity (BCVA) was summarized by the ETDRS visual acuity log score. For subjects without a score due to inability to read the ETDRS chart, the log score was imputed as 1.6 for the purpose of treatment comparisons. Subjects without a score because the manifest refraction was not completed were excluded from the analysis. Treatment comparisons for BCVA were performed by pairwise Wilcoxon tests.
Time Frame30 days

Outcome Measure Data

Analysis Population Description
Subjects with scores at time point.
Arm/Group TitleBalanced Salt Solution (BSS)OMS302 Mydriatic Solution (PE)OMS302 Anti-inflammatory Solution (KE)OMS302 Solution
Arm/Group DescriptionBalanced Salt Solution (BSS) Balanced Salt Solution (BSS)OMS302 Mydriatic Solution OMS302 Mydriatic SolutionOMS302 Anti-inflammatory Solution OMS302 Anti-inflammatory SolutionOMS302 Solution OMS302 Solution
Measure Participants56555554
Mean (Standard Deviation) [Log score]
0.1
(0.2)
0.1
(0.2)
0.1
(0.2)
0.1
(0.1)
Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Balanced Salt Solution (BSS), OMS302 Solution
Comments
Type of Statistical Test Superiority or Other
Comments
Statistical Test of Hypothesisp-Value0.675
CommentsTreatment comparisons between OMS302 and each of the other three groups are based on Wilcoxon rank-sum test.
MethodWilcoxon rank-sum test
Comments
Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection OMS302 Mydriatic Solution (PE), OMS302 Solution
Comments
Type of Statistical Test Superiority or Other
Comments
Statistical Test of Hypothesisp-Value0.825
CommentsTreatment comparisons between OMS302 and each of the other three groups are based on Wilcoxon rank-sum test.
MethodWIlcoxon rank-sum test
Comments
Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection OMS302 Anti-inflammatory Solution (KE), OMS302 Solution
Comments
Type of Statistical Test Superiority or Other
Comments
Statistical Test of Hypothesisp-Value0.668
CommentsTreatment comparisons between OMS302 and each of the other three groups are based on Wilcoxon rank-sum test.
MethodWilcoxon rank-sum test
Comments
51. Secondary Outcome
TitlePostoperative Ocular Inflammation in Summed Ocular Inflammation Score (SOIS) Grade, Baseline
DescriptionPostoperative inflammation as measured using the Summed Ocular Inflammation Score (SOIS), summarized by treatment arm and time point. Ocular inflammation was evaluated by measuring the anterior chamber cell count and flare using a slit lamp biomicroscope. SOIS was calculated by adding the average of subject's anterior chamber cells and flare grades. The minimum SOIS was 0 (indicating absence of inflammation), whereas the maximum SOIS was 8. Grading was as follows: Anterior Chamber Cells: Grade None = 0/no cells; Grade Mild = +1/1-5 cells; Grade Moderate = +2/6-15 cells; Grade Severe = +3/16-30 cells; Grade Very Severe = +4/>30 cells. Anterior Chamber Flare: Grade None = 0/no Tyndall effect; Grade Mild = +1/barely discernable Tyndall effect; Grade Moderate = +2/moderately intense Tyndall beam in anterior chamber; Grade Severe = +3/severely intense Tyndall beam; Grade Very Severe = +4/very severely intense Tyndall beam with a white and milky appearance to the aqueous
Time FrameBaseline

Outcome Measure Data

Analysis Population Description
Subjects with scores at time point.
Arm/Group TitleBalanced Salt Solution (BSS)OMS302 Mydriatic Solution (PE)OMS302 Anti-inflammatory Solution (KE)OMS302 Solution
Arm/Group DescriptionBalanced Salt Solution (BSS) Balanced Salt Solution (BSS)OMS302 Mydriatic Solution OMS302 Mydriatic SolutionOMS302 Anti-inflammatory Solution OMS302 Anti-inflammatory SolutionOMS302 Solution OMS302 Solution
Measure Participants56565555
Mean (Standard Deviation) [units on a scale]
0.0
(0.0)
0.0
(0.0)
0.0
(0.1)
0.0
(0.1)
Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Balanced Salt Solution (BSS), OMS302 Solution
Comments
Type of Statistical Test Superiority or Other
Comments
Statistical Test of Hypothesisp-Value0.2066
CommentsTreatment comparisons between OMS302 and each of the other three groups are based on ANOVA model with covariates treatment group and the LOCS II grade group.
MethodANOVA
Comments
Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection OMS302 Mydriatic Solution (PE), OMS302 Solution
Comments
Type of Statistical Test Superiority or Other
Comments
Statistical Test of Hypothesisp-Value0.2066
CommentsTreatment comparisons between OMS302 and each of the other three groups are based on ANOVA model with covariates treatment group and the LOCS II grade group.
MethodANOVA
Comments
Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection OMS302 Anti-inflammatory Solution (KE), OMS302 Solution
Comments
Type of Statistical Test Superiority or Other
Comments
Statistical Test of Hypothesisp-Value0.5263
CommentsTreatment comparisons between OMS302 and each of the other three groups are based on ANOVA model with covariates treatment group and the LOCS II grade group.
MethodANOVA
Comments
52. Secondary Outcome
TitlePostoperative Ocular Inflammation in Summed Ocular Inflammation Score (SOIS) Grade, 2 Hours Post Surgery
DescriptionTPostoperative inflammation as measured using the Summed Ocular Inflammation Score (SOIS), summarized by treatment arm and time point. Ocular inflammation was evaluated by measuring the anterior chamber cell count and flare using a slit lamp biomicroscope. SOIS was calculated by adding the average of subject's anterior chamber cells and flare grades. The minimum SOIS was 0 (indicating absence of inflammation), whereas the maximum SOIS was 8. Grading was as follows: Anterior Chamber Cells: Grade None = 0/no cells; Grade Mild = +1/1-5 cells; Grade Moderate = +2/6-15 cells; Grade Severe = +3/16-30 cells; Grade Very Severe = +4/>30 cells. Anterior Chamber Flare: Grade None = 0/no Tyndall effect; Grade Mild = +1/barely discernable Tyndall effect; Grade Moderate = +2/moderately intense Tyndall beam in anterior chamber; Grade Severe = +3/severely intense Tyndall beam; Grade Very Severe = +4/very severely intense Tyndall beam with a white and milky appearance to the aqueous
Time FrameTwo hours

Outcome Measure Data

Analysis Population Description
Subjects with scores at time point.
Arm/Group TitleBalanced Salt Solution (BSS)OMS302 Mydriatic Solution (PE)OMS302 Anti-inflammatory Solution (KE)OMS302 Solution
Arm/Group DescriptionBalanced Salt Solution (BSS) Balanced Salt Solution (BSS)OMS302 Mydriatic Solution OMS302 Mydriatic SolutionOMS302 Anti-inflammatory Solution OMS302 Anti-inflammatory SolutionOMS302 Solution OMS302 Solution
Measure Participants56565555
Mean (Standard Deviation) [units on a scale]
2.7
(1.4)
2.2
(1.3)
2.5
(1.3)
2.5
(1.2)
Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Balanced Salt Solution (BSS), OMS302 Solution
Comments
Type of Statistical Test Superiority or Other
Comments
Statistical Test of Hypothesisp-Value0.4222
CommentsTreatment comparisons between OMS302 and each of the other three groups are based on ANOVA model with covariates treatment group and the LOCS II grade group.
MethodANOVA
Comments
Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection OMS302 Mydriatic Solution (PE), OMS302 Solution
Comments
Type of Statistical Test Superiority or Other
Comments
Statistical Test of Hypothesisp-Value0.2712
CommentsTreatment comparisons between OMS302 and each of the other three groups are based on ANOVA model with covariates treatment group and the LOCS II grade group.
MethodANOVA
Comments
Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection OMS302 Anti-inflammatory Solution (KE), OMS302 Solution
Comments
Type of Statistical Test Superiority or Other
Comments
Statistical Test of Hypothesisp-Value0.8819
CommentsTreatment comparisons between OMS302 and each of the other three groups are based on ANOVA model with covariates treatment group and the LOCS II grade group.
MethodANOVA
Comments
53. Secondary Outcome
TitlePostoperative Ocular Inflammation in Summed Ocular Inflammation Score (SOIS) Grade, Day 1
DescriptionPostoperative inflammation as measured using the Summed Ocular Inflammation Score (SOIS), summarized by treatment arm and time point. Ocular inflammation was evaluated by measuring the anterior chamber cell count and flare using a slit lamp biomicroscope. SOIS was calculated by adding the average of subject's anterior chamber cells and flare grades. The minimum SOIS was 0 (indicating absence of inflammation), whereas the maximum SOIS was 8. Grading was as follows: Anterior Chamber Cells: Grade None = 0/no cells; Grade Mild = +1/1-5 cells; Grade Moderate = +2/6-15 cells; Grade Severe = +3/16-30 cells; Grade Very Severe = +4/>30 cells. Anterior Chamber Flare: Grade None = 0/no Tyndall effect; Grade Mild = +1/barely discernable Tyndall effect; Grade Moderate = +2/moderately intense Tyndall beam in anterior chamber; Grade Severe = +3/severely intense Tyndall beam; Grade Very Severe = +4/very severely intense Tyndall beam with a white and milky appearance to the aqueous
Time FrameOne day

Outcome Measure Data

Analysis Population Description
Subjects with scores at time point.
Arm/Group TitleBalanced Salt Solution (BSS)OMS302 Mydriatic Solution (PE)OMS302 Anti-inflammatory Solution (KE)OMS302 Solution
Arm/Group DescriptionBalanced Salt Solution (BSS) Balanced Salt Solution (BSS)OMS302 Mydriatic Solution OMS302 Mydriatic SolutionOMS302 Anti-inflammatory Solution OMS302 Anti-inflammatory SolutionOMS302 Solution OMS302 Solution
Measure Participants56565555
Mean (Standard Deviation) [units on a scale]
2.7
(1.4)
2.3
(1.3)
2.6
(1.3)
2.2
(1.1)
Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Balanced Salt Solution (BSS), OMS302 Solution
Comments
Type of Statistical Test Superiority or Other
Comments
Statistical Test of Hypothesisp-Value0.0510
CommentsTreatment comparisons between OMS302 and each of the other three groups are based on ANOVA model with covariates treatment group and the LOCS II grade group.
MethodANOVA
Comments
Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection OMS302 Mydriatic Solution (PE), OMS302 Solution
Comments
Type of Statistical Test Superiority or Other
Comments
Statistical Test of Hypothesisp-Value0.8084
CommentsTreatment comparisons between OMS302 and each of the other three groups are based on ANOVA model with covariates treatment group and the LOCS II grade group.
MethodANOVA
Comments
Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection OMS302 Anti-inflammatory Solution (KE), OMS302 Solution
Comments
Type of Statistical Test Superiority or Other
Comments
Statistical Test of Hypothesisp-Value0.1495
CommentsTreatment comparisons between OMS302 and each of the other three groups are based on ANOVA model with covariates treatment group and the LOCS II grade group.
MethodANOVA
Comments
54. Secondary Outcome
TitlePostoperative Ocular Inflammation in Summed Ocular Inflammation Score (SOIS) Grade, Day 2
DescriptionPostoperative inflammation as measured using the Summed Ocular Inflammation Score (SOIS), summarized by treatment arm and time point. Ocular inflammation was evaluated by measuring the anterior chamber cell count and flare using a slit lamp biomicroscope. SOIS was calculated by adding the average of subject's anterior chamber cells and flare grades. The minimum SOIS was 0 (indicating absence of inflammation), whereas the maximum SOIS was 8. Grading was as follows: Anterior Chamber Cells: Grade None = 0/no cells; Grade Mild = +1/1-5 cells; Grade Moderate = +2/6-15 cells; Grade Severe = +3/16-30 cells; Grade Very Severe = +4/>30 cells. Anterior Chamber Flare: Grade None = 0/no Tyndall effect; Grade Mild = +1/barely discernable Tyndall effect; Grade Moderate = +2/moderately intense Tyndall beam in anterior chamber; Grade Severe = +3/severely intense Tyndall beam; Grade Very Severe = +4/very severely intense Tyndall beam with a white and milky appearance to the aqueous
Time FrameTwo days

Outcome Measure Data

Analysis Population Description
Subjects with scores at time point.
Arm/Group TitleBalanced Salt Solution (BSS)OMS302 Mydriatic Solution (PE)OMS302 Anti-inflammatory Solution (KE)OMS302 Solution
Arm/Group DescriptionBalanced Salt Solution (BSS) Balanced Salt Solution (BSS)OMS302 Mydriatic Solution OMS302 Mydriatic SolutionOMS302 Anti-inflammatory Solution OMS302 Anti-inflammatory SolutionOMS302 Solution OMS302 Solution
Measure Participants56565555
Mean (Standard Deviation) [units on a scale]
2.4
(1.3)
2.0
(1.2)
2.6
(1.4)
2.2
(1.2)
Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Balanced Salt Solution (BSS), OMS302 Solution
Comments
Type of Statistical Test Superiority or Other
Comments
Statistical Test of Hypothesisp-Value0.4099
CommentsTreatment comparisons between OMS302 and each of the other three groups are based on ANOVA model with covariates treatment group and the LOCS II grade group.
MethodANOVA
Comments
Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection OMS302 Mydriatic Solution (PE), OMS302 Solution
Comments
Type of Statistical Test Superiority or Other
Comments
Statistical Test of Hypothesisp-Value0.6499
CommentsTreatment comparisons between OMS302 and each of the other three groups are based on ANOVA model with covariates treatment group and the LOCS II grade group.
MethodANOVA
Comments
Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection OMS302 Anti-inflammatory Solution (KE), OMS302 Solution
Comments
Type of Statistical Test Superiority or Other
Comments
Statistical Test of Hypothesisp-Value0.0765
CommentsTreatment comparisons between OMS302 and each of the other three groups are based on ANOVA model with covariates treatment group and the LOCS II grade group.
MethodANOVA
Comments
55. Secondary Outcome
TitlePostoperative Ocular Inflammation in Summed Ocular Inflammation Score (SOIS) Grade, Day 7
DescriptionPostoperative inflammation as measured using the Summed Ocular Inflammation Score (SOIS), summarized by treatment arm and time point. Ocular inflammation was evaluated by measuring the anterior chamber cell count and flare using a slit lamp biomicroscope. SOIS was calculated by adding the average of subject's anterior chamber cells and flare grades. The minimum SOIS was 0 (indicating absence of inflammation), whereas the maximum SOIS was 8. Grading was as follows: Anterior Chamber Cells: Grade None = 0/no cells; Grade Mild = +1/1-5 cells; Grade Moderate = +2/6-15 cells; Grade Severe = +3/16-30 cells; Grade Very Severe = +4/>30 cells. Anterior Chamber Flare: Grade None = 0/no Tyndall effect; Grade Mild = +1/barely discernable Tyndall effect; Grade Moderate = +2/moderately intense Tyndall beam in anterior chamber; Grade Severe = +3/severely intense Tyndall beam; Grade Very Severe = +4/very severely intense Tyndall beam with a white and milky appearance to the aqueous
Time FrameSeven days

Outcome Measure Data

Analysis Population Description
Subjects with scores at time point.
Arm/Group TitleBalanced Salt Solution (BSS)OMS302 Mydriatic Solution (PE)OMS302 Anti-inflammatory Solution (KE)OMS302 Solution
Arm/Group DescriptionBalanced Salt Solution (BSS) Balanced Salt Solution (BSS)OMS302 Mydriatic Solution OMS302 Mydriatic SolutionOMS302 Anti-inflammatory Solution OMS302 Anti-inflammatory SolutionOMS302 Solution OMS302 Solution
Measure Participants56565355
Mean (Standard Deviation) [units on a scale]
1.5
(1.2)
1.4
(1.2)
1.5
(1.3)
1.9
(1.3)
Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Balanced Salt Solution (BSS), OMS302 Solution
Comments
Type of Statistical Test Superiority or Other
Comments
Statistical Test of Hypothesisp-Value0.0688
CommentsTreatment comparisons between OMS302 and each of the other three groups are based on ANOVA model with covariates treatment group and the LOCS II grade group.
MethodANOVA
Comments
Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection OMS302 Mydriatic Solution (PE), OMS302 Solution
Comments
Type of Statistical Test Superiority or Other
Comments
Statistical Test of Hypothesisp-Value0.0314
CommentsTreatment comparisons between OMS302 and each of the other three groups are based on ANOVA model with covariates treatment group and the LOCS II grade group.
MethodANOVA
Comments
Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection OMS302 Anti-inflammatory Solution (KE), OMS302 Solution
Comments
Type of Statistical Test Superiority or Other
Comments
Statistical Test of Hypothesisp-Value0.0775
CommentsTreatment comparisons between OMS302 and each of the other three groups are based on ANOVA model with covariates treatment group and the LOCS II grade group.
MethodANOVA
Comments
56. Secondary Outcome
TitlePostoperative Ocular Inflammation in Summed Ocular Inflammation Score (SOIS) Grade, Day 14
DescriptionPostoperative inflammation as measured using the Summed Ocular Inflammation Score (SOIS), summarized by treatment arm and time point. Ocular inflammation was evaluated by measuring the anterior chamber cell count and flare using a slit lamp biomicroscope. SOIS was calculated by adding the average of subject's anterior chamber cells and flare grades. The minimum SOIS was 0 (indicating absence of inflammation), whereas the maximum SOIS was 8. Grading was as follows: Anterior Chamber Cells: Grade None = 0/no cells; Grade Mild = +1/1-5 cells; Grade Moderate = +2/6-15 cells; Grade Severe = +3/16-30 cells; Grade Very Severe = +4/>30 cells. Anterior Chamber Flare: Grade None = 0/no Tyndall effect; Grade Mild = +1/barely discernable Tyndall effect; Grade Moderate = +2/moderately intense Tyndall beam in anterior chamber; Grade Severe = +3/severely intense Tyndall beam; Grade Very Severe = +4/very severely intense Tyndall beam with a white and milky appearance to the aqueous
Time Frame14 days

Outcome Measure Data

Analysis Population Description
Subjects with scores at time point.
Arm/Group TitleBalanced Salt Solution (BSS)OMS302 Mydriatic Solution (PE)OMS302 Anti-inflammatory Solution (KE)OMS302 Solution
Arm/Group DescriptionBalanced Salt Solution (BSS) Balanced Salt Solution (BSS)OMS302 Mydriatic Solution OMS302 Mydriatic SolutionOMS302 Anti-inflammatory Solution OMS302 Anti-inflammatory SolutionOMS302 Solution OMS302 Solution
Measure Participants55565553
Mean (Standard Deviation) [units on a scale]
0.7
(0.7)
0.6
(0.8)
0.7
(0.9)
0.8
(0.9)
Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Balanced Salt Solution (BSS), OMS302 Solution
Comments
Type of Statistical Test Superiority or Other
Comments
Statistical Test of Hypothesisp-Value0.5369
CommentsTreatment comparisons between OMS302 and each of the other three groups are based on ANOVA model with covariates treatment group and the LOCS II grade group.
MethodANOVA
Comments
Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection OMS302 Mydriatic Solution (PE), OMS302 Solution
Comments
Type of Statistical Test Superiority or Other
Comments
Statistical Test of Hypothesisp-Value0.3763
CommentsTreatment comparisons between OMS302 and each of the other three groups are based on ANOVA model with covariates treatment group and the LOCS II grade group.
MethodANOVA
Comments
Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection OMS302 Anti-inflammatory Solution (KE), OMS302 Solution
Comments
Type of Statistical Test Superiority or Other
Comments
Statistical Test of Hypothesisp-Value0.6144
CommentsTreatment comparisons between OMS302 and each of the other three groups are based on ANOVA model with covariates treatment group and the LOCS II grade group.
MethodANOVA
Comments
57. Secondary Outcome
TitlePostoperative Ocular Inflammation in Summed Ocular Inflammation Score (SOIS) Grade, Day 30
DescriptionPostoperative inflammation as measured using the Summed Ocular Inflammation Score (SOIS), summarized by treatment arm and time point. Ocular inflammation was evaluated by measuring the anterior chamber cell count and flare using a slit lamp biomicroscope. SOIS was calculated by adding the average of subject's anterior chamber cells and flare grades. The minimum SOIS was 0 (indicating absence of inflammation), whereas the maximum SOIS was 8. Grading was as follows: Anterior Chamber Cells: Grade None = 0/no cells; Grade Mild = +1/1-5 cells; Grade Moderate = +2/6-15 cells; Grade Severe = +3/16-30 cells; Grade Very Severe = +4/>30 cells. Anterior Chamber Flare: Grade None = 0/no Tyndall effect; Grade Mild = +1/barely discernable Tyndall effect; Grade Moderate = +2/moderately intense Tyndall beam in anterior chamber; Grade Severe = +3/severely intense Tyndall beam; Grade Very Severe = +4/very severely intense Tyndall beam with a white and milky appearance to the aqueous
Time Frame30 days

Outcome Measure Data

Analysis Population Description
Subjects with scores at time point.
Arm/Group TitleBalanced Salt Solution (BSS)OMS302 Mydriatic Solution (PE)OMS302 Anti-inflammatory Solution (KE)OMS302 Solution
Arm/Group DescriptionBalanced Salt Solution (BSS) Balanced Salt Solution (BSS)OMS302 Mydriatic Solution OMS302 Mydriatic SolutionOMS302 Anti-inflammatory Solution OMS302 Anti-inflammatory SolutionOMS302 Solution OMS302 Solution
Measure Participants56555554
Mean (Standard Deviation) [units on a scale]
0.4
(0.7)
0.2
(0.5)
0.3
(0.6)
0.2
(0.4)
Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Balanced Salt Solution (BSS), OMS302 Solution
Comments
Type of Statistical Test Superiority or Other
Comments
Statistical Test of Hypothesisp-Value0.1374
CommentsTreatment comparisons between OMS302 and each of the other three groups are based on ANOVA model with covariates treatment group and the LOCS II grade group.
MethodANOVA
Comments
Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection OMS302 Mydriatic Solution (PE), OMS302 Solution
Comments
Type of Statistical Test Superiority or Other
Comments
Statistical Test of Hypothesisp-Value0.9146
CommentsTreatment comparisons between OMS302 and each of the other three groups are based on ANOVA model with covariates treatment group and the LOCS II grade group.
MethodANOVA
Comments
Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection OMS302 Anti-inflammatory Solution (KE), OMS302 Solution
Comments
Type of Statistical Test Superiority or Other
Comments
Statistical Test of Hypothesisp-Value0.7599
CommentsTreatment comparisons between OMS302 and each of the other three groups are based on ANOVA model with covariates treatment group and the LOCS II grade group.
MethodANOVA
Comments
58. Secondary Outcome
TitleSubjects With Postoperative Ocular Inflammation SOIS = 0, Baseline
DescriptionNumber of subjects with Summed Ocular Inflammation Score (SOIS) = 0, summarized by treatment arm and time point. Ocular inflammation was evaluated by measuring the anterior chamber cell count and flare using a slit lamp biomicroscope. SOIS was calculated by adding the average of subject's anterior chamber cells and flare grades. The minimum SOIS was 0 (indicating absence of inflammation), whereas the maximum SOIS was 8. Grading was as follows: Anterior Chamber Cells: Grade None = 0/no cells; Grade Mild = +1/1-5 cells; Grade Moderate = +2/6-15 cells; Grade Severe = +3/16-30 cells; Grade Very Severe = +4/>30 cells. Anterior Chamber Flare: Grade None = 0/no Tyndall effect; Grade Mild = +1/barely discernable Tyndall effect; Grade Moderate = +2/moderately intense Tyndall beam in anterior chamber; Grade Severe = +3/severely intense Tyndall beam; Grade Very Severe = +4/very severely intense Tyndall beam with a white and milky appearance to the aqueous
Time FrameBaseline

Outcome Measure Data

Analysis Population Description
Subjects with scores at time point.
Arm/Group TitleBalanced Salt Solution (BSS)OMS302 Mydriatic Solution (PE)OMS302 Anti-inflammatory Solution (KE)OMS302 Solution
Arm/Group DescriptionBalanced Salt Solution (BSS) Balanced Salt Solution (BSS)OMS302 Mydriatic Solution OMS302 Mydriatic SolutionOMS302 Anti-inflammatory Solution OMS302 Anti-inflammatory SolutionOMS302 Solution OMS302 Solution
Measure Participants56565555
Number [participants]
56
98.2%
56
103.7%
54
98.2%
54
96.4%
Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Balanced Salt Solution (BSS), OMS302 Solution
Comments
Type of Statistical Test Superiority or Other
Comments
Statistical Test of Hypothesisp-Value0.317
CommentsTreatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.
MethodCochran-Mantel-Haenszel
Comments
Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection OMS302 Mydriatic Solution (PE), OMS302 Solution
Comments
Type of Statistical Test Superiority or Other
Comments
Statistical Test of Hypothesisp-Value0.317
CommentsTreatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.
MethodCochran-Mantel-Haenszel
Comments
Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection OMS302 Anti-inflammatory Solution (KE), OMS302 Solution
Comments
Type of Statistical Test Superiority or Other
Comments
Statistical Test of Hypothesisp-Value1.000
CommentsTreatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.
MethodCochran-Mantel-Haenszel
Comments
59. Secondary Outcome
TitleSubjects With Postoperative Ocular Inflammation SOIS = 0, Two Hours Post-surgery
DescriptionNumber of subjects with Summed Ocular Inflammation Score (SOIS) = 0, summarized by treatment arm and time point. Ocular inflammation was evaluated by measuring the anterior chamber cell count and flare using a slit lamp biomicroscope. SOIS was calculated by adding the average of subject's anterior chamber cells and flare grades. The minimum SOIS was 0 (indicating absence of inflammation), whereas the maximum SOIS was 8. Grading was as follows: Anterior Chamber Cells: Grade None = 0/no cells; Grade Mild = +1/1-5 cells; Grade Moderate = +2/6-15 cells; Grade Severe = +3/16-30 cells; Grade Very Severe = +4/>30 cells. Anterior Chamber Flare: Grade None = 0/no Tyndall effect; Grade Mild = +1/barely discernable Tyndall effect; Grade Moderate = +2/moderately intense Tyndall beam in anterior chamber; Grade Severe = +3/severely intense Tyndall beam; Grade Very Severe = +4/very severely intense Tyndall beam with a white and milky appearance to the aqueous
Time FrameTwo hours

Outcome Measure Data

Analysis Population Description
Subjects with scores at time point.
Arm/Group TitleBalanced Salt Solution (BSS)OMS302 Mydriatic Solution (PE)OMS302 Anti-inflammatory Solution (KE)OMS302 Solution
Arm/Group DescriptionBalanced Salt Solution (BSS) Balanced Salt Solution (BSS)OMS302 Mydriatic Solution OMS302 Mydriatic SolutionOMS302 Anti-inflammatory Solution OMS302 Anti-inflammatory SolutionOMS302 Solution OMS302 Solution
Measure Participants56565555
Number [participants]
1
1.8%
3
5.6%
1
1.8%
2
3.6%
Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Balanced Salt Solution (BSS), OMS302 Solution
Comments
Type of Statistical Test Superiority or Other
Comments
Statistical Test of Hypothesisp-Value0.559
CommentsTreatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.
MethodCochran-Mantel-Haenszel
Comments
Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection OMS302 Mydriatic Solution (PE), OMS302 Solution
Comments
Type of Statistical Test Superiority or Other
Comments
Statistical Test of Hypothesisp-Value0.647
CommentsTreatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.
MethodCochran-Mantel-Haenszel
Comments
Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection OMS302 Anti-inflammatory Solution (KE), OMS302 Solution
Comments
Type of Statistical Test Superiority or Other
Comments
Statistical Test of Hypothesisp-Value0.559
CommentsTreatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.
MethodCochran-Mantel-Haenszel
Comments
60. Secondary Outcome
TitleSubjects With Postoperative Ocular Inflammation SOIS = 0, Day 1
DescriptionNumber of subjects with Summed Ocular Inflammation Score (SOIS) = 0, summarized by treatment arm and time point. Ocular inflammation was evaluated by measuring the anterior chamber cell count and flare using a slit lamp biomicroscope. SOIS was calculated by adding the average of subject's anterior chamber cells and flare grades. The minimum SOIS was 0 (indicating absence of inflammation), whereas the maximum SOIS was 8. Grading was as follows: Anterior Chamber Cells: Grade None = 0/no cells; Grade Mild = +1/1-5 cells; Grade Moderate = +2/6-15 cells; Grade Severe = +3/16-30 cells; Grade Very Severe = +4/>30 cells. Anterior Chamber Flare: Grade None = 0/no Tyndall effect; Grade Mild = +1/barely discernable Tyndall effect; Grade Moderate = +2/moderately intense Tyndall beam in anterior chamber; Grade Severe = +3/severely intense Tyndall beam; Grade Very Severe = +4/very severely intense Tyndall beam with a white and milky appearance to the aqueous
Time FrameOne day

Outcome Measure Data

Analysis Population Description
Subjects with scores at time point.
Arm/Group TitleBalanced Salt Solution (BSS)OMS302 Mydriatic Solution (PE)OMS302 Anti-inflammatory Solution (KE)OMS302 Solution
Arm/Group DescriptionBalanced Salt Solution (BSS) Balanced Salt Solution (BSS)OMS302 Mydriatic Solution OMS302 Mydriatic SolutionOMS302 Anti-inflammatory Solution OMS302 Anti-inflammatory SolutionOMS302 Solution OMS302 Solution
Measure Participants56565555
Number [participants]
1
1.8%
1
1.9%
1
1.8%
0
0%
Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Balanced Salt Solution (BSS), OMS302 Solution
Comments
Type of Statistical Test Superiority or Other
Comments
Statistical Test of Hypothesisp-Value0.317
CommentsTreatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.
MethodCochran-Mantel-Haenszel
Comments
Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection OMS302 Mydriatic Solution (PE), OMS302 Solution
Comments
Type of Statistical Test Superiority or Other
Comments
Statistical Test of Hypothesisp-Value0.335
CommentsTreatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.
MethodCochran-Mantel-Haenszel
Comments
Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection OMS302 Anti-inflammatory Solution (KE), OMS302 Solution
Comments
Type of Statistical Test Superiority or Other
Comments
Statistical Test of Hypothesisp-Value0.317
CommentsTreatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.
MethodCochran-Mantel-Haenszel
Comments
61. Secondary Outcome
TitleSubjects With Postoperative Ocular Inflammation SOIS = 0, Day 2
DescriptionNumber of subjects with Summed Ocular Inflammation Score (SOIS) = 0, summarized by treatment arm and time point. Ocular inflammation was evaluated by measuring the anterior chamber cell count and flare using a slit lamp biomicroscope. SOIS was calculated by adding the average of subject's anterior chamber cells and flare grades. The minimum SOIS was 0 (indicating absence of inflammation), whereas the maximum SOIS was 8. Grading was as follows: Anterior Chamber Cells: Grade None = 0/no cells; Grade Mild = +1/1-5 cells; Grade Moderate = +2/6-15 cells; Grade Severe = +3/16-30 cells; Grade Very Severe = +4/>30 cells. Anterior Chamber Flare: Grade None = 0/no Tyndall effect; Grade Mild = +1/barely discernable Tyndall effect; Grade Moderate = +2/moderately intense Tyndall beam in anterior chamber; Grade Severe = +3/severely intense Tyndall beam; Grade Very Severe = +4/very severely intense Tyndall beam with a white and milky appearance to the aqueous
Time FrameTwo days

Outcome Measure Data

Analysis Population Description
Subjects with scores at time point.
Arm/Group TitleBalanced Salt Solution (BSS)OMS302 Mydriatic Solution (PE)OMS302 Anti-inflammatory Solution (KE)OMS302 Solution
Arm/Group DescriptionBalanced Salt Solution (BSS) Balanced Salt Solution (BSS)OMS302 Mydriatic Solution OMS302 Mydriatic SolutionOMS302 Anti-inflammatory Solution OMS302 Anti-inflammatory SolutionOMS302 Solution OMS302 Solution
Measure Participants56565555
Number [participants]
1
1.8%
2
3.7%
1
1.8%
1
1.8%
Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Balanced Salt Solution (BSS), OMS302 Solution
Comments
Type of Statistical Test Superiority or Other
Comments
Statistical Test of Hypothesisp-Value1.000
CommentsTreatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.
MethodCochran-Mantel-Haenszel
Comments
Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection OMS302 Mydriatic Solution (PE), OMS302 Solution
Comments
Type of Statistical Test Superiority or Other
Comments
Statistical Test of Hypothesisp-Value0.559
CommentsTreatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.
MethodCochran-Mantel-Haenszel
Comments
Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection OMS302 Anti-inflammatory Solution (KE), OMS302 Solution
Comments
Type of Statistical Test Superiority or Other
Comments
Statistical Test of Hypothesisp-Value1.000
CommentsTreatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.
MethodCochran-Mantel-Haenszel
Comments
62. Secondary Outcome
TitleSubjects With Postoperative Ocular Inflammation SOIS = 0, Day 7
DescriptionNumber of subjects with Summed Ocular Inflammation Score (SOIS) = 0, summarized by treatment arm and time point. Ocular inflammation was evaluated by measuring the anterior chamber cell count and flare using a slit lamp biomicroscope. SOIS was calculated by adding the average of subject's anterior chamber cells and flare grades. The minimum SOIS was 0 (indicating absence of inflammation), whereas the maximum SOIS was 8. Grading was as follows: Anterior Chamber Cells: Grade None = 0/no cells; Grade Mild = +1/1-5 cells; Grade Moderate = +2/6-15 cells; Grade Severe = +3/16-30 cells; Grade Very Severe = +4/>30 cells. Anterior Chamber Flare: Grade None = 0/no Tyndall effect; Grade Mild = +1/barely discernable Tyndall effect; Grade Moderate = +2/moderately intense Tyndall beam in anterior chamber; Grade Severe = +3/severely intense Tyndall beam; Grade Very Severe = +4/very severely intense Tyndall beam with a white and milky appearance to the aqueous
Time FrameSeven days

Outcome Measure Data

Analysis Population Description
Subjects with scores at time point.
Arm/Group TitleBalanced Salt Solution (BSS)OMS302 Mydriatic Solution (PE)OMS302 Anti-inflammatory Solution (KE)OMS302 Solution
Arm/Group DescriptionBalanced Salt Solution (BSS) Balanced Salt Solution (BSS)OMS302 Mydriatic Solution OMS302 Mydriatic SolutionOMS302 Anti-inflammatory Solution OMS302 Anti-inflammatory SolutionOMS302 Solution OMS302 Solution
Measure Participants56565355
Number [participants]
9
15.8%
11
20.4%
12
21.8%
8
14.3%
Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Balanced Salt Solution (BSS), OMS302 Solution
Comments
Type of Statistical Test Superiority or Other
Comments
Statistical Test of Hypothesisp-Value0.824
CommentsTreatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.
MethodCochran-Mantel-Haenszel
Comments
Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection OMS302 Mydriatic Solution (PE), OMS302 Solution
Comments
Type of Statistical Test Superiority or Other
Comments
Statistical Test of Hypothesisp-Value0.476
CommentsTreatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.
MethodCochran-Mantel-Haenszel
Comments
Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection OMS302 Anti-inflammatory Solution (KE), OMS302 Solution
Comments
Type of Statistical Test Superiority or Other
Comments
Statistical Test of Hypothesisp-Value0.281
CommentsTreatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.
MethodCochran-Mantel-Haenszel
Comments
63. Secondary Outcome
TitleSubjects With Postoperative Ocular Inflammation SOIS = 0, Day 14
DescriptionNumber of subjects with Summed Ocular Inflammation Score (SOIS) = 0, summarized by treatment arm and time point. Ocular inflammation was evaluated by measuring the anterior chamber cell count and flare using a slit lamp biomicroscope. SOIS was calculated by adding the average of subject's anterior chamber cells and flare grades. The minimum SOIS was 0 (indicating absence of inflammation), whereas the maximum SOIS was 8. Grading was as follows: Anterior Chamber Cells: Grade None = 0/no cells; Grade Mild = +1/1-5 cells; Grade Moderate = +2/6-15 cells; Grade Severe = +3/16-30 cells; Grade Very Severe = +4/>30 cells. Anterior Chamber Flare: Grade None = 0/no Tyndall effect; Grade Mild = +1/barely discernable Tyndall effect; Grade Moderate = +2/moderately intense Tyndall beam in anterior chamber; Grade Severe = +3/severely intense Tyndall beam; Grade Very Severe = +4/very severely intense Tyndall beam with a white and milky appearance to the aqueous
Time Frame14 days

Outcome Measure Data

Analysis Population Description
Subjects with scores at time point.
Arm/Group TitleBalanced Salt Solution (BSS)OMS302 Mydriatic Solution (PE)OMS302 Anti-inflammatory Solution (KE)OMS302 Solution
Arm/Group DescriptionBalanced Salt Solution (BSS) Balanced Salt Solution (BSS)OMS302 Mydriatic Solution OMS302 Mydriatic SolutionOMS302 Anti-inflammatory Solution OMS302 Anti-inflammatory SolutionOMS302 Solution OMS302 Solution
Measure Participants55565553
Number [participants]
25
43.9%
29
53.7%
28
50.9%
25
44.6%
Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Balanced Salt Solution (BSS), OMS302 Solution
Comments
Type of Statistical Test Superiority or Other
Comments
Statistical Test of Hypothesisp-Value0.842
CommentsTreatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.
MethodCochran-Mantel-Haenszel
Comments
Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection OMS302 Mydriatic Solution (PE), OMS302 Solution
Comments
Type of Statistical Test Superiority or Other
Comments
Statistical Test of Hypothesisp-Value0.619
CommentsTreatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.
MethodCochran-Mantel-Haenszel
Comments
Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection OMS302 Anti-inflammatory Solution (KE), OMS302 Solution
Comments
Type of Statistical Test Superiority or Other
Comments
Statistical Test of Hypothesisp-Value0.711
CommentsTreatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.
MethodCochran-Mantel-Haenszel
Comments
64. Secondary Outcome
TitleSubjects With Postoperative Ocular Inflammation SOIS = 0, Day 30
DescriptionNumber of subjects with Summed Ocular Inflammation Score (SOIS) = 0, summarized by treatment arm and time point. Ocular inflammation was evaluated by measuring the anterior chamber cell count and flare using a slit lamp biomicroscope. SOIS was calculated by adding the average of subject's anterior chamber cells and flare grades. The minimum SOIS was 0 (indicating absence of inflammation), whereas the maximum SOIS was 8. Grading was as follows: Anterior Chamber Cells: Grade None = 0/no cells; Grade Mild = +1/1-5 cells; Grade Moderate = +2/6-15 cells; Grade Severe = +3/16-30 cells; Grade Very Severe = +4/>30 cells. Anterior Chamber Flare: Grade None = 0/no Tyndall effect; Grade Mild = +1/barely discernable Tyndall effect; Grade Moderate = +2/moderately intense Tyndall beam in anterior chamber; Grade Severe = +3/severely intense Tyndall beam; Grade Very Severe = +4/very severely intense Tyndall beam with a white and milky appearance to the aqueous
Time Frame30 days

Outcome Measure Data

Analysis Population Description
Subjects with scores at time point.
Arm/Group TitleBalanced Salt Solution (BSS)OMS302 Mydriatic Solution (PE)OMS302 Anti-inflammatory Solution (KE)OMS302 Solution
Arm/Group DescriptionBalanced Salt Solution (BSS) Balanced Salt Solution (BSS)OMS302 Mydriatic Solution OMS302 Mydriatic SolutionOMS302 Anti-inflammatory Solution OMS302 Anti-inflammatory SolutionOMS302 Solution OMS302 Solution
Measure Participants56555554
Number [participants]
40
70.2%
43
79.6%
42
76.4%
40
71.4%
Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Balanced Salt Solution (BSS), OMS302 Solution
Comments
Type of Statistical Test Superiority or Other
Comments
Statistical Test of Hypothesisp-Value0.773
CommentsTreatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.
MethodCochran-Mantel-Haenszel
Comments
Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection OMS302 Mydriatic Solution (PE), OMS302 Solution
Comments
Type of Statistical Test Superiority or Other
Comments
Statistical Test of Hypothesisp-Value0.592
CommentsTreatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.
MethodCochran-Mantel-Haenszel
Comments
Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection OMS302 Anti-inflammatory Solution (KE), OMS302 Solution
Comments
Type of Statistical Test Superiority or Other
Comments
Statistical Test of Hypothesisp-Value0.787
CommentsTreatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.
MethodCochran-Mantel-Haenszel
Comments
65. Secondary Outcome
TitlePostoperative Mean Anterior Chamber Cell Count, Two Hours Post-Surgery
DescriptionThe mean anterior chamber cell count was calculated as the average of the two anterior chamber cell counts. If a cell count was indicated as > 30, it was imputed as 45 for the purpose of treatment comparisons which was performed using pairwise Wilcoxon tests.
Time FrameTwo hours

Outcome Measure Data

Analysis Population Description
Subjects with data at time point.
Arm/Group TitleBalanced Salt Solution (BSS)OMS302 Mydriatic Solution (PE)OMS302 Anti-inflammatory Solution (KE)OMS302 Solution
Arm/Group DescriptionBalanced Salt Solution (BSS) Balanced Salt Solution (BSS)OMS302 Mydriatic Solution OMS302 Mydriatic SolutionOMS302 Anti-inflammatory Solution OMS302 Anti-inflammatory SolutionOMS302 Solution OMS302 Solution
Measure Participants54525353
Mean (Standard Deviation) [cells]
11.2
(9.4)
9.2
(11.1)
10.9
(10.1)
10.3
(8.6)
Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Balanced Salt Solution (BSS), OMS302 Solution
Comments
Type of Statistical Test Superiority or Other
Comments
Statistical Test of Hypothesisp-Value0.695
CommentsTreatment comparisons between OMS302 and each of the other three groups were based on Wilcoxon rank-sum test. For subjects with mean count > 30, the mean count was imputed as 45 for the purpose of treatment comparisons.
MethodWilcoxon rank-sum test
Comments
Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection OMS302 Mydriatic Solution (PE), OMS302 Solution
Comments
Type of Statistical Test Superiority or Other
Comments
Statistical Test of Hypothesisp-Value0.166
CommentsTreatment comparisons between OMS302 and each of the other three groups were based on Wilcoxon rank-sum test. For subjects with mean count > 30, the mean count was imputed as 45 for the purpose of treatment comparisons.
MethodWilcoxon rank-sum test
Comments
Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection OMS302 Anti-inflammatory Solution (KE), OMS302 Solution
Comments
Type of Statistical Test Superiority or Other
Comments
Statistical Test of Hypothesisp-Value0.987
CommentsTreatment comparisons between OMS302 and each of the other three groups were based on Wilcoxon rank-sum test. For subjects with mean count > 30, the mean count was imputed as 45 for the purpose of treatment comparisons.
MethodWilcoxon rank-sum test
Comments
66. Secondary Outcome
TitlePostoperative Mean Anterior Chamber Cell Count, Day 1
DescriptionThe mean anterior chamber cell count was calculated as the average of the two anterior chamber cell counts. If a cell count was indicated as > 30, it was imputed as 45 for the purpose of treatment comparisons which was performed using pairwise Wilcoxon tests.
Time FrameOne day

Outcome Measure Data

Analysis Population Description
Subjects with data at time point.
Arm/Group TitleBalanced Salt Solution (BSS)OMS302 Mydriatic Solution (PE)OMS302 Anti-inflammatory Solution (KE)OMS302 Solution
Arm/Group DescriptionBalanced Salt Solution (BSS) Balanced Salt Solution (BSS)OMS302 Mydriatic Solution OMS302 Mydriatic SolutionOMS302 Anti-inflammatory Solution OMS302 Anti-inflammatory SolutionOMS302 Solution OMS302 Solution
Measure Participants53555453
Mean (Standard Deviation) [cells]
11.2
(9.5)
9.3
(9.7)
10.4
(8.9)
8.4
(6.7)
Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Balanced Salt Solution (BSS), OMS302 Solution
Comments
Type of Statistical Test Superiority or Other
Comments
Statistical Test of Hypothesisp-Value0.134
CommentsTreatment comparisons between OMS302 and each of the other three groups were based on Wilcoxon rank-sum test. For subjects with mean count > 30, the mean count was imputed as 45 for the purpose of treatment comparisons.
MethodWilcoxon rank-sum test
Comments
Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection OMS302 Mydriatic Solution (PE), OMS302 Solution
Comments
Type of Statistical Test Superiority or Other
Comments
Statistical Test of Hypothesisp-Value0.710
CommentsTreatment comparisons between OMS302 and each of the other three groups were based on Wilcoxon rank-sum test. For subjects with mean count > 30, the mean count was imputed as 45 for the purpose of treatment comparisons.
MethodWilcoxon rank-sum test
Comments
Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection OMS302 Anti-inflammatory Solution (KE), OMS302 Solution
Comments
Type of Statistical Test Superiority or Other
Comments
Statistical Test of Hypothesisp-Value0.310
CommentsTreatment comparisons between OMS302 and each of the other three groups were based on Wilcoxon rank-sum test. For subjects with mean count > 30, the mean count was imputed as 45 for the purpose of treatment comparisons.
MethodWilcoxon rank-sum test
Comments
67. Secondary Outcome
TitlePostoperative Mean Anterior Chamber Cell Count, Day 2
DescriptionThe mean anterior chamber cell count was calculated as the average of the two anterior chamber cell counts. If a cell count was indicated as > 30, it was imputed as 45 for the purpose of treatment comparisons which was performed using pairwise Wilcoxon tests.
Time FrameTwo days

Outcome Measure Data

Analysis Population Description
Subjects with data at time point.
Arm/Group TitleBalanced Salt Solution (BSS)OMS302 Mydriatic Solution (PE)OMS302 Anti-inflammatory Solution (KE)OMS302 Solution
Arm/Group DescriptionBalanced Salt Solution (BSS) Balanced Salt Solution (BSS)OMS302 Mydriatic Solution OMS302 Mydriatic SolutionOMS302 Anti-inflammatory Solution OMS302 Anti-inflammatory SolutionOMS302 Solution OMS302 Solution
Measure Participants54545354
Mean (Standard Deviation) [cells]
9.1
(6.4)
6.8
(7.8)
10.2
(7.6)
7.2
(6.0)
Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Balanced Salt Solution (BSS), OMS302 Solution
Comments
Type of Statistical Test Superiority or Other
Comments
Statistical Test of Hypothesisp-Value0.086
CommentsTreatment comparisons between OMS302 and each of the other three groups were based on Wilcoxon rank-sum test. For subjects with mean count > 30, the mean count was imputed as 45 for the purpose of treatment comparisons.
MethodWilcoxon rank-sum test
Comments
Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection OMS302 Mydriatic Solution (PE), OMS302 Solution
Comments
Type of Statistical Test Superiority or Other
Comments
Statistical Test of Hypothesisp-Value0.183
CommentsTreatment comparisons between OMS302 and each of the other three groups were based on Wilcoxon rank-sum test. For subjects with mean count > 30, the mean count was imputed as 45 for the purpose of treatment comparisons.
MethodWilcoxon rank-sum test
Comments
Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection OMS302 Anti-inflammatory Solution (KE), OMS302 Solution
Comments
Type of Statistical Test Superiority or Other
Comments
Statistical Test of Hypothesisp-Value0.029
CommentsTreatment comparisons between OMS302 and each of the other three groups were based on Wilcoxon rank-sum test. For subjects with mean count > 30, the mean count was imputed as 45 for the purpose of treatment comparisons.
MethodWilcoxon rank-sum test
Comments
68. Secondary Outcome
TitlePostoperative Mean Anterior Chamber Cell Count, Day 7
DescriptionThe mean anterior chamber cell count was calculated as the average of the two anterior chamber cell counts. If a cell count was indicated as > 30, it was imputed as 45 for the purpose of treatment comparisons which was performed using pairwise Wilcoxon tests.
Time FrameSeven days

Outcome Measure Data

Analysis Population Description
Subjects with data at time point.
Arm/Group TitleBalanced Salt Solution (BSS)OMS302 Mydriatic Solution (PE)OMS302 Anti-inflammatory Solution (KE)OMS302 Solution
Arm/Group DescriptionBalanced Salt Solution (BSS) Balanced Salt Solution (BSS)OMS302 Mydriatic Solution OMS302 Mydriatic SolutionOMS302 Anti-inflammatory Solution OMS302 Anti-inflammatory SolutionOMS302 Solution OMS302 Solution
Measure Participants55555254
Mean (Standard Deviation) [cells]
4.5
(5.2)
4.2
(7.5)
3.6
(4.6)
6.9
(10.1)
Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Balanced Salt Solution (BSS), OMS302 Solution
Comments
Type of Statistical Test Superiority or Other
Comments
Statistical Test of Hypothesisp-Value0.206
CommentsTreatment comparisons between OMS302 and each of the other three groups were based on Wilcoxon rank-sum test. For subjects with mean count > 30, the mean count was imputed as 45 for the purpose of treatment comparisons.
MethodWilcoxon rank-sum test
Comments
Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection OMS302 Mydriatic Solution (PE), OMS302 Solution
Comments
Type of Statistical Test Superiority or Other
Comments
Statistical Test of Hypothesisp-Value0.021
CommentsTreatment comparisons between OMS302 and each of the other three groups were based on Wilcoxon rank-sum test. For subjects with mean count > 30, the mean count was imputed as 45 for the purpose of treatment comparisons.
MethodWilcoxon rank-sum test
Comments
Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection OMS302 Anti-inflammatory Solution (KE), OMS302 Solution
Comments
Type of Statistical Test Superiority or Other
Comments
Statistical Test of Hypothesisp-Value0.026
CommentsTreatment comparisons between OMS302 and each of the other three groups were based on Wilcoxon rank-sum test. For subjects with mean count > 30, the mean count was imputed as 45 for the purpose of treatment comparisons.
MethodWilcoxon rank-sum test
Comments
69. Secondary Outcome
TitlePostoperative Mean Anterior Chamber Cell Count, Day 14
DescriptionThe mean anterior chamber cell count was calculated as the average of the two anterior chamber cell counts. If a cell count was indicated as > 30, it was imputed as 45 for the purpose of treatment comparisons which was performed using pairwise Wilcoxon tests.
Time Frame14 days

Outcome Measure Data

Analysis Population Description
Subjects with data at time point.
Arm/Group TitleBalanced Salt Solution (BSS)OMS302 Mydriatic Solution (PE)OMS302 Anti-inflammatory Solution (KE)OMS302 Solution
Arm/Group DescriptionBalanced Salt Solution (BSS) Balanced Salt Solution (BSS)OMS302 Mydriatic Solution OMS302 Mydriatic SolutionOMS302 Anti-inflammatory Solution OMS302 Anti-inflammatory SolutionOMS302 Solution OMS302 Solution
Measure Participants54555452
Mean (Standard Deviation) [cells]
1.6
(2.1)
1.3
(2.4)
1.6
(2.7)
2.1
(3.9)
Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Balanced Salt Solution (BSS), OMS302 Solution
Comments
Type of Statistical Test Superiority or Other
Comments
Statistical Test of Hypothesisp-Value0.822
CommentsTreatment comparisons between OMS302 and each of the other three groups were based on Wilcoxon rank-sum test. For subjects with mean count > 30, the mean count was imputed as 45 for the purpose of treatment comparisons.
MethodWilcoxon rank-sum test
Comments
Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection OMS302 Mydriatic Solution (PE), OMS302 Solution
Comments
Type of Statistical Test Superiority or Other
Comments
Statistical Test of Hypothesisp-Value0.424
CommentsTreatment comparisons between OMS302 and each of the other three groups were based on Wilcoxon rank-sum test. For subjects with mean count > 30, the mean count was imputed as 45 for the purpose of treatment comparisons.
MethodWilcoxon rank-sum test
Comments
Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection OMS302 Anti-inflammatory Solution (KE), OMS302 Solution
Comments
Type of Statistical Test Superiority or Other
Comments
Statistical Test of Hypothesisp-Value0.695
CommentsTreatment comparisons between OMS302 and each of the other three groups were based on Wilcoxon rank-sum test. For subjects with mean count > 30, the mean count was imputed as 45 for the purpose of treatment comparisons.
MethodWilcoxon rank-sum test
Comments
70. Secondary Outcome
TitlePostoperative Mean Anterior Chamber Cell Count, Day 30
DescriptionThe mean anterior chamber cell count was calculated as the average of the two anterior chamber cell counts. If a cell count was indicated as > 30, it was imputed as 45 for the purpose of treatment comparisons which was performed using pairwise Wilcoxon tests.
Time Frame30 days

Outcome Measure Data

Analysis Population Description
Subjects with data at time point.
Arm/Group TitleBalanced Salt Solution (BSS)OMS302 Mydriatic Solution (PE)OMS302 Anti-inflammatory Solution (KE)OMS302 Solution
Arm/Group DescriptionBalanced Salt Solution (BSS) Balanced Salt Solution (BSS)OMS302 Mydriatic Solution OMS302 Mydriatic SolutionOMS302 Anti-inflammatory Solution OMS302 Anti-inflammatory SolutionOMS302 Solution OMS302 Solution
Measure Participants55555553
Mean (Standard Deviation) [cells]
1.1
(2.3)
0.3
(0.8)
0.5
(1.2)
0.5
(1.2)
Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Balanced Salt Solution (BSS), OMS302 Solution
Comments
Type of Statistical Test Superiority or Other
Comments
Statistical Test of Hypothesisp-Value0.489
CommentsTreatment comparisons between OMS302 and each of the other three groups were based on Wilcoxon rank-sum test. For subjects with mean count > 30, the mean count was imputed as 45 for the purpose of treatment comparisons.
MethodWilcoxon rank-sum test
Comments
Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection OMS302 Mydriatic Solution (PE), OMS302 Solution
Comments
Type of Statistical Test Superiority or Other
Comments
Statistical Test of Hypothesisp-Value0.459
CommentsTreatment comparisons between OMS302 and each of the other three groups were based on Wilcoxon rank-sum test. For subjects with mean count > 30, the mean count was imputed as 45 for the purpose of treatment comparisons.
MethodWilcoxon rank-sum test
Comments
Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection OMS302 Anti-inflammatory Solution (KE), OMS302 Solution
Comments
Type of Statistical Test Superiority or Other
Comments
Statistical Test of Hypothesisp-Value0.990
CommentsTreatment comparisons between OMS302 and each of the other three groups were based on Wilcoxon rank-sum test. For subjects with mean count > 30, the mean count was imputed as 45 for the purpose of treatment comparisons.
MethodWilcoxon rank-sum test
Comments
71. Secondary Outcome
TitleOcular Pain VAS Score After Day 0
DescriptionVAS pain scores (where 0 = no pain and 100 = worst possible pain) after the day of surgery were summarized.
Time Frame43 days

Outcome Measure Data

Analysis Population Description
Subjects with data at time point.
Arm/Group TitleBalanced Salt Solution (BSS)OMS302 Mydriatic Solution (PE)OMS302 Anti-inflammatory Solution (KE)OMS302 Solution
Arm/Group DescriptionBalanced Salt Solution (BSS) Balanced Salt Solution (BSS)OMS302 Mydriatic Solution OMS302 Mydriatic SolutionOMS302 Anti-inflammatory Solution OMS302 Anti-inflammatory SolutionOMS302 Solution OMS302 Solution
Measure Participants56565555
Day 1 AM; n = 55, 54, 55, 55
13.4
(21.7)
13.0
(18.1)
2.7
(8.3)
7.7
(18.4)
Day 1 PM; n = 54, 54, 51, 51
6.6
(10.2)
12.6
(19.4)
6.8
(15.1)
11.6
(20.6)
Day 2 AM; n = 55, 55, 55, 54
7.7
(11.1)
10.8
(18.2)
9.5
(18.9)
10.9
(13.7)
Day 2 PM; n = 52, 55, 53, 53
5.3
(9.4)
7.3
(15.5)
7.2
(15.4)
6.4
(11.8)
Day 3 AM; n = 53, 53, 53, 49
4.1
(7.0)
5.4
(11.5)
4.8
(11.3)
8.9
(18.8)
Day 3 PM; n = 53, 55, 55, 50
4.7
(9.8)
5.1
(11.0)
3.7
(8.7)
4.4
(10.7)
Day 4 AM; n = 52, 53, 52, 48
2.8
(6.0)
3.5
(8.3)
3.9
(10.8)
5.0
(10.5)
Day 4 PM; n = 53, 52, 55, 52
4.5
(9.2)
3.7
(9.4)
4.8
(14.2)
4.1
(8.3)
Day 5 AM; n = 54, 54, 53, 50
3.6
(9.9)
6.4
(18.5)
3.4
(10.6)
6.5
(14.8)
Day 5 PM; n = 54, 55, 54, 51
3.9
(8.5)
3.9
(10.4)
3.3
(9.6)
5.2
(12.5)
Day 6 AM; n = 53, 54, 53, 50
3.5
(6.3)
4.6
(13.3)
3.6
(10.2)
6.0
(14.3)
Day 6 PM; n = 54, 53, 54, 50
2.9
(5.5)
4.0
(11.0)
2.7
(9.3)
4.6
(12.2)
Day 7; n = 54, 54, 54, 53
2.1
(5.3)
3.5
(9.0)
3.3
(11.0)
4.5
(13.9)
Day 8; n = 22, 28, 21, 13
1.3
(2.3)
4.9
(14.7)
0.6
(1.0)
2.2
(6.3)
Day 9; n = 4, 4, 3, 2
0.0
(0.0)
0.3
(0.5)
0.0
(0.0)
0.0
(0.0)
Day 10; 1, 2, 3, 1
0.0
(0)
0.5
(0.7)
0.0
(0.0)
0.0
(0)
Day 11; n = 1, 2, 4, 1
0.0
(0)
0.5
(0.7)
0.0
(0.0)
0.0
(0)
Day 12; n = 2, 2, 2, 1
2.5
(3.5)
0.5
(0.7)
0.0
(0.0)
0.0
(0)
Day 13; n = 11, 8, 15, 9
1.1
(3.3)
0.3
(0.5)
0.7
(1.8)
0.0
(0.0)
Day 14; n = 17, 16, 21, 26
2.7
(7.7)
0.2
(0.5)
1.0
(2.2)
0.6
(1.4)
Day 15; 22, 25, 18, 14
2.1
(3.6)
1.8
(8.0)
0.2
(0.4)
4.5
(13.4)
Day 16; 1, 7, 2, 5
0.0
(0)
0.0
(0.0)
0.0
(0.0)
0.0
(0.0)
Day 17; n = 2, 0, 0, 1
4.5
(6.4)
NA
(NA)
NA
(NA)
0.0
(0)
Day 18; n = 0, 0, 1, 0
NA
(NA)
NA
(NA)
0.0
(0)
NA
(NA)
Day 19; n = 1, 0, 0, 0
0.0
(0)
NA
(NA)
NA
(NA)
NA
(NA)
Day 20; n = 0, 1, 0, 0
NA
(NA)
0.0
(0)
NA
(NA)
NA
(NA)
Day 21; n = 1, 0, 0, 0
0.0
(0)
NA
(NA)
NA
(NA)
NA
(NA)
Day 22; n = 0, 1, 1, 0
NA
(NA)
0.0
(0)
0.0
(0)
NA
(NA)
Day 26; n = 0, 1, 0, 0
NA
(NA)
0.0
(0)
NA
(NA)
NA
(NA)
Day 27; n = 9, 9, 6, 5
0.6
(1.7)
0.1
(0.3)
0.0
(0.0)
0.2
(0.4)
Day 28; n = 11, 12, 14, 25
0.6
(0.9)
0.0
(0.0)
0.8
(2.2)
0.2
(0.7)
Day 29; n = 16, 14, 18, 13
0.1
(0.3)
0.1
(0.3)
1.6
(5.1)
0.0
(0.0)
Day 30; n = 15, 13, 6, 5
0.8
(2.8)
0.3
(0.9)
0.0
(0.0)
0.8
(1.8)
Day 31; n = 2, 2, 1, 3
0.0
(0.0)
0.0
(0.0)
0.0
(0)
0.0
(0.0)
Day 32; n = 0, 0, 5, 0
NA
(NA)
NA
(NA)
0.0
(0.0)
NA
(NA)
Day 33;n = 0, 0, 2, 0
NA
(NA)
NA
(NA)
0.0
(0.0)
NA
(NA)
Day 34; n = 1, 0, 0, 0
0.0
(0)
NA
(NA)
NA
(NA)
NA
(NA)
Day 35; n = 1, 0, 1, 1
0.0
(0)
NA
(NA)
0.0
(0)
0.0
(0)
Day 36; n = 1, 1, 1, 1
0.0
(0)
50.0
(0)
0.0
(0)
0.0
(0)
Day 37; n = 0, 1, 0, 0
NA
(NA)
0.0
(0)
NA
(NA)
NA
(NA)
Day 43; n = 0, 1, 0, 0
NA
(NA)
0.0
(0)
NA
(NA)
NA
(NA)
72. Secondary Outcome
TitlePostoperative Use of Ophthalmic Anti-inflammatory Medications
DescriptionOphthalmic anti-inflammatory medications were identified by reviewing concomitant medications. Subject incidence of ophthalmic anti-inflammatory medication use by post-surgery day was presented. Treatment comparisons were performed using a Cochran-Mantel- Haenszel (CMH) test adjusting for the stratification factor LOCS II grade.
Time Frameup to 30 days

Outcome Measure Data

Analysis Population Description
All randomized subjects
Arm/Group TitleBalanced Salt Solution (BSS)OMS302 Mydriatic Solution (PE)OMS302 Anti-inflammatory Solution (KE)OMS302 Solution
Arm/Group DescriptionBalanced Salt Solution (BSS) Balanced Salt Solution (BSS)OMS302 Mydriatic Solution OMS302 Mydriatic SolutionOMS302 Anti-inflammatory Solution OMS302 Anti-inflammatory SolutionOMS302 Solution OMS302 Solution
Measure Participants56565556
Bromfenac sodium
2
3.5%
9
16.7%
8
14.5%
6
10.7%
Dexamethasone
1
1.8%
0
0%
0
0%
2
3.6%
Difluprednate
6
10.5%
8
14.8%
7
12.7%
7
12.5%
Ketorlac
0
0%
0
0%
1
1.8%
0
0%
Ketorolac tromethamine
0
0%
1
1.9%
0
0%
0
0%
Loteprednol etabonate
0
0%
1
1.9%
1
1.8%
0
0%
Nepafenac
10
17.5%
4
7.4%
7
12.7%
4
7.1%
Prednisolone acetate
25
43.9%
29
53.7%
28
50.9%
29
51.8%
Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Balanced Salt Solution (BSS), OMS302 Solution
Comments
Type of Statistical Test Superiority or Other
Comments
Statistical Test of Hypothesisp-Value0.4575
CommentsTreatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.
MethodCochran-Mantel-Haenszel
Comments
Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection OMS302 Mydriatic Solution (PE), OMS302 Solution
Comments
Type of Statistical Test Superiority or Other
Comments
Statistical Test of Hypothesisp-Value0.8318
CommentsTreatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.
MethodCochran-Mantel-Haenszel
Comments
Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection OMS302 Anti-inflammatory Solution (KE), OMS302 Solution
Comments
Type of Statistical Test Superiority or Other
Comments
Statistical Test of Hypothesisp-Value0.8946
CommentsTreatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.
MethodCochran-Mantel-Haenszel
Comments
73. Secondary Outcome
TitleUse of Pain Medications at Day 1
DescriptionOcular pain medications were identified by reviewing concomitant medications. Subject incidence of ocular pain medication use at day 1 and post day 1 were presented. Treatment comparisons were performed using a Cochran-Mantel- Haenszel (CMH) test adjusting for the stratification factor LOCS II grade.
Time FrameOne day

Outcome Measure Data

Analysis Population Description
All randomized subjects
Arm/Group TitleBalanced Salt Solution (BSS)OMS302 Mydriatic Solution (PE)OMS302 Anti-inflammatory Solution (KE)OMS302 Solution
Arm/Group DescriptionBalanced Salt Solution (BSS) Balanced Salt Solution (BSS)OMS302 Mydriatic Solution OMS302 Mydriatic SolutionOMS302 Anti-inflammatory Solution OMS302 Anti-inflammatory SolutionOMS302 Solution OMS302 Solution
Measure Participants56565556
Axotal
0
0%
0
0%
0
0%
1
1.8%
Diclofenac
1
1.8%
0
0%
0
0%
0
0%
Ibuprofen
1
1.8%
0
0%
1
1.8%
0
0%
Naproxen Sodium
0
0%
0
0%
1
1.8%
0
0%
Paracetamol
23
40.4%
26
48.1%
9
16.4%
18
32.1%
Tramadol
0
0%
2
3.7%
0
0%
0
0%
Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Balanced Salt Solution (BSS), OMS302 Solution
Comments
Type of Statistical Test Superiority or Other
Comments
Statistical Test of Hypothesisp-Value0.1570
CommentsOcular pain medications will be identified by reviewing concomitant medications. Subject incidence of ocular pain medication use at day 1 and post day 1 will be presented. Treatment comparisons will be performed using methodology 1.
MethodCochran-Mantel-Haenszel
Comments
Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection OMS302 Mydriatic Solution (PE), OMS302 Solution
Comments
Type of Statistical Test Superiority or Other
Comments
Statistical Test of Hypothesisp-Value0.0839
CommentsOcular pain medications will be identified by reviewing concomitant medications. Subject incidence of ocular pain medication use at day 1 and post day 1 will be presented. Treatment comparisons will be performed using methodology 1.
MethodCochran-Mantel-Haenszel
Comments
Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection OMS302 Anti-inflammatory Solution (KE), OMS302 Solution
Comments
Type of Statistical Test Superiority or Other
Comments
Statistical Test of Hypothesisp-Value0.0920
CommentsOcular pain medications will be identified by reviewing concomitant medications. Subject incidence of ocular pain medication use at day 1 and post day 1 will be presented. Treatment comparisons will be performed using methodology 1.
MethodCochran-Mantel-Haenszel
Comments
74. Secondary Outcome
TitleUse of Pain Medications After Day 1
DescriptionOcular pain medications were identified by reviewing concomitant medications. Subject incidence of ocular pain medication use at day 1 and post day 1 were presented. Treatment comparisons were performed using a Cochran-Mantel- Haenszel (CMH) test adjusting for the stratification factor LOCS II grade.
Time Frameup to 30 days

Outcome Measure Data

Analysis Population Description
All randomized subjects
Arm/Group TitleBalanced Salt Solution (BSS)OMS302 Mydriatic Solution (PE)OMS302 Anti-inflammatory Solution (KE)OMS302 Solution
Arm/Group DescriptionBalanced Salt Solution (BSS) Balanced Salt Solution (BSS)OMS302 Mydriatic Solution OMS302 Mydriatic SolutionOMS302 Anti-inflammatory Solution OMS302 Anti-inflammatory SolutionOMS302 Solution OMS302 Solution
Measure Participants56565556
Axotal
0
0%
0
0%
0
0%
1
1.8%
Celecoxib
1
1.8%
0
0%
0
0%
0
0%
Diclofenac
1
1.8%
0
0%
0
0%
0
0%
Hydrocodone
1
1.8%
0
0%
0
0%
0
0%
Ibuprofen
1
1.8%
0
0%
0
0%
0
0%
Naproxen
1
1.8%
0
0%
0
0%
0
0%
Naproxen Sodium
0
0%
0
0%
0
0%
1
1.8%
Paracetamol
23
40.4%
21
38.9%
20
36.4%
29
51.8%
Tramadol
0
0%
2
3.7%
0
0%
0
0%
Tylox
0
0%
1
1.9%
0
0%
0
0%
Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Balanced Salt Solution (BSS), OMS302 Solution
Comments
Type of Statistical Test Superiority or Other
Comments
Statistical Test of Hypothesisp-Value0.711
CommentsTreatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.
MethodCochran-Mantel-Haenszel
Comments
Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection OMS302 Mydriatic Solution (PE), OMS302 Solution
Comments
Type of Statistical Test Superiority or Other
Comments
Statistical Test of Hypothesisp-Value0.253
CommentsTreatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.
MethodCochran-Mantel-Haenszel
Comments
Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection OMS302 Anti-inflammatory Solution (KE), OMS302 Solution
Comments
Type of Statistical Test Superiority or Other
Comments
Statistical Test of Hypothesisp-Value0.104
CommentsTreatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.
MethodCochran-Mantel-Haenszel
Comments

Adverse Events

Time Frame30 days
Adverse Event Reporting Description
Arm/Group TitleBalanced Salt Solution (BSS)OMS302 Mydriatic Solution (PE)OMS302 Anti-inflammatory Solution (KE)OMS302 Solution
Arm/Group DescriptionBalanced Salt Solution (BSS) Balanced Salt Solution (BSS)OMS302 Mydriatic Solution OMS302 Mydriatic SolutionOMS302 Anti-inflammatory Solution OMS302 Anti-inflammatory SolutionOMS302 Solution OMS302 Solution
All Cause Mortality
Balanced Salt Solution (BSS)OMS302 Mydriatic Solution (PE)OMS302 Anti-inflammatory Solution (KE)OMS302 Solution
Affected / at Risk (%)# EventsAffected / at Risk (%)# EventsAffected / at Risk (%)# EventsAffected / at Risk (%)# Events
Total/ (NaN) / (NaN) / (NaN) / (NaN)
Serious Adverse Events
Balanced Salt Solution (BSS)OMS302 Mydriatic Solution (PE)OMS302 Anti-inflammatory Solution (KE)OMS302 Solution
Affected / at Risk (%)# EventsAffected / at Risk (%)# EventsAffected / at Risk (%)# EventsAffected / at Risk (%)# Events
Total0/57 (0%) 1/54 (1.9%) 0/55 (0%) 0/56 (0%)
Nervous system disorders
Facial neuralgia0/57 (0%) 1/54 (1.9%) 0/55 (0%) 0/56 (0%)
Other (Not Including Serious) Adverse Events
Balanced Salt Solution (BSS)OMS302 Mydriatic Solution (PE)OMS302 Anti-inflammatory Solution (KE)OMS302 Solution
Affected / at Risk (%)# EventsAffected / at Risk (%)# EventsAffected / at Risk (%)# EventsAffected / at Risk (%)# Events
Total45/57 (78.9%) 43/54 (79.6%) 37/55 (67.3%) 47/56 (83.9%)
Eye disorders
Eye pain16/57 (28.1%) 21/54 (38.9%) 13/55 (23.6%) 17/56 (30.4%)
Eye inflammation5/57 (8.8%) 9/54 (16.7%) 12/55 (21.8%) 11/56 (19.6%)
Photophobia1/57 (1.8%) 3/54 (5.6%) 2/55 (3.6%) 4/56 (7.1%)
Iritis0/57 (0%) 2/54 (3.7%) 2/55 (3.6%) 3/56 (5.4%)
General disorders
Inflammation13/57 (22.8%) 12/54 (22.2%) 8/55 (14.5%) 11/56 (19.6%)
Pain11/57 (19.3%) 8/54 (14.8%) 8/55 (14.5%) 9/56 (16.1%)
Nervous system disorders
Headache5/57 (8.8%) 2/54 (3.7%) 4/55 (7.3%) 4/56 (7.1%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

The PI agreed not to publish or otherwise to disclose Study data without prior written consent from the sponsor for a period of 24 months following Study completion or until data are published in a combined publication (whichever occurs first). The sponsor can review communications containing results prior to public release and embargo those communications for a period that is no longer than 60 days from the date of receipt of the non-public communication. The sponsor cannot extend the embargo.

Results Point of Contact

Name/TitleChief Medical Officer
OrganizationOmeros Corporation
Phone(206) 676-5000
Emailswhitaker@omeros.com
Responsible Party:
Omeros Corporation
ClinicalTrials.gov Identifier:
NCT01193127
Other Study ID Numbers:
  • C09-001
First Posted:
Sep 1, 2010
Last Update Posted:
Aug 28, 2014
Last Verified:
Aug 1, 2014