Loteprednol Etabonate Versus Vehicle for the Treatment of Inflammation and Pain Following Cataract Surgery

Sponsor
Bausch & Lomb Incorporated (Industry)
Overall Status
Completed
CT.gov ID
NCT01010633
Collaborator
(none)
406
Enrollment
1
Location
2
Arms
9
Duration (Months)
45.3
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This study is being conducted to compare the safety and efficacy of loteprednol etabonate compared to vehicle for the treatment of postoperative inflammation and pain following cataract surgery.

Condition or DiseaseIntervention/TreatmentPhase
  • Drug: Vehicle of Loteprednol Etabonate
  • Drug: Loteprednol Etabonate
Phase 3

Study Design

Study Type:
Interventional
Actual Enrollment :
406 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
Study Start Date :
Nov 1, 2009
Actual Primary Completion Date :
Jun 1, 2010
Actual Study Completion Date :
Aug 1, 2010

Arms and Interventions

ArmIntervention/Treatment
Experimental: Loteprednol Etabonate

Loteprednol etabonate

Drug: Loteprednol Etabonate
1 to 2 drops of study drug administered into the study eye, 4 times a day for approximately 14 days.

Placebo Comparator: Vehicle

Vehicle of loteprednol etabonate

Drug: Vehicle of Loteprednol Etabonate
1 to 2 drops of vehicle administered into the study eye, 4 times a day for approximately 14 days.

Outcome Measures

Primary Outcome Measures

  1. Resolution of Anterior Chamber Cells (ACC). [Visit 5 (Postoperative day 8)]

    Number of Study eyes with complete resolution(Grade 0) of anterior chamber cells (ACC) for loteprednol and vehicle. Accumulation of white cells in aqueous graded on a scale of 0-4 where grade 0=no cells. Investigators assessed ACC using a slit lamp.

  2. Grade 0 Pain [Visit 5 (Postoperative Day 8)]

    Number of eyes with grade 0 ocular pain. Ocular pain, defined as a positive sensation of the eye, based on a 0-5 scale where grade 0 equaled no pain and grade 5 equaled severe pain. Ocular pain graded by participants.

Secondary Outcome Measures

  1. Resolution of Anterior Chamber Cells. [At visits 4-7- postoperative day 3, 8,15 & 18]

    Study eyes with complete resolution of anterior chamber cells (ACC)

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • Subjects who are at least 18 years of age.

  • Subjects who are candidates for routine, uncomplicated cataract surgery.

  • Subjects who, in the Investigator's opinion, have potential postoperative pinholed Snellen visual acuity (VA) of at least 20/200 in the study eye.

Exclusion Criteria:
  • Subjects who have known hypersensitivity or contraindication to the study drug or components.

  • Subjects with a severe/serious ocular condition, or any other unstable medical condition, that in the investigator's opinion may preclude study treatment or follow-up.

  • Subjects with elevated intraocular pressure (>/= 21mm Hg), uncontrolled glaucoma, or being treated for glaucoma in the study eye.

  • Subjects who are monocular or have pinholed Snellen VA 20/200 or worse in the non-study eye.

Contacts and Locations

Locations

SiteCityStateCountryPostal Code
1Bausch & Lomb, Inc.RochesterNew YorkUnited States14609

Sponsors and Collaborators

  • Bausch & Lomb Incorporated

Investigators

  • Study Director: Laura Trusso, Bausch & Lomb Incorporated

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Bausch & Lomb Incorporated
ClinicalTrials.gov Identifier:
NCT01010633
Other Study ID Numbers:
  • 576
First Posted:
Nov 10, 2009
Last Update Posted:
Jan 9, 2012
Last Verified:
Dec 1, 2011
Additional relevant MeSH terms:

Study Results

Participant Flow

Recruitment DetailsThis study was initiated at 20 clinics in the United States (US). Three sites did not enroll any participants. The study was conducted at the remaining 17 sites. First participant was enrolled 11/23/2009 and last participant completed 6/25/2010.
Pre-assignment Detail406 participants eligible for cataract surgery were enrolled in the study (safety population). 397 participants completed the study.
Arm/Group TitleLoteprednolVehicle
Arm/Group DescriptionLoteprednol etabonate 0.5%Vehicle of loteprednol etabonate
Period Title: Overall Study
STARTED203203
COMPLETED199198
NOT COMPLETED45

Baseline Characteristics

Arm/Group TitleLoteprednolVehicleTotal
Arm/Group DescriptionLoteprednol etabonate 0.5%Vehicle of loteprednol etabonateTotal of all reporting groups
Overall Participants203203406
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]
69.3
(8.73)
69.0
(9.80)
69.1
(9.27)
Sex: Female, Male (Count of Participants)
Female
109
53.7%
122
60.1%
231
56.9%
Male
94
46.3%
81
39.9%
175
43.1%
Race/Ethnicity, Customized (participants) [Number]
American Indian or Alaska Native
0
0%
1
0.5%
1
0.2%
Asian
2
1%
3
1.5%
5
1.2%
Native Hawaiian or Other Pacific Islander
1
0.5%
0
0%
1
0.2%
Black or African American
20
9.9%
16
7.9%
36
8.9%
White
176
86.7%
182
89.7%
358
88.2%
Other
4
2%
1
0.5%
5
1.2%

Outcome Measures

1. Primary Outcome
TitleResolution of Anterior Chamber Cells (ACC).
DescriptionNumber of Study eyes with complete resolution(Grade 0) of anterior chamber cells (ACC) for loteprednol and vehicle. Accumulation of white cells in aqueous graded on a scale of 0-4 where grade 0=no cells. Investigators assessed ACC using a slit lamp.
Time FrameVisit 5 (Postoperative day 8)

Outcome Measure Data

Analysis Population Description
Intent to treat (ITT) population
Arm/Group TitleLoteprednolVehicle
Arm/Group DescriptionLoteprednol Etabonate 0.5%Vehicle of Loteprednol Etabonate
Measure Participants203203
Measure Eyes203203
Number [Eyes]
62
33
Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Loteprednol, Vehicle
Comments
Type of Statistical Test Superiority or Other
Comments
Statistical Test of Hypothesisp-Value<0.001
Comments
MethodChi-squared
Comments
Method of EstimationEstimation ParameterMean Difference (Final Values)
Estimated Value14.3
Confidence Interval (2-Sided) 95%
5.7 to 22.9
Parameter Dispersion Type:
Value:
Estimation Comments
2. Secondary Outcome
TitleResolution of Anterior Chamber Cells.
DescriptionStudy eyes with complete resolution of anterior chamber cells (ACC)
Time FrameAt visits 4-7- postoperative day 3, 8,15 & 18

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group TitleLoteprednolVehicle
Arm/Group DescriptionLoteprednol Etabonate 0.5%Vehicle of Loteprednol Etabonate
Measure Participants203203
Visit 4
17
11
Visit 5
62
33
Visit 6
102
44
Visit 7
96
45
3. Primary Outcome
TitleGrade 0 Pain
DescriptionNumber of eyes with grade 0 ocular pain. Ocular pain, defined as a positive sensation of the eye, based on a 0-5 scale where grade 0 equaled no pain and grade 5 equaled severe pain. Ocular pain graded by participants.
Time FrameVisit 5 (Postoperative Day 8)

Outcome Measure Data

Analysis Population Description
Intent to treat population (ITT)
Arm/Group TitleLoteprednolVehicle
Arm/Group DescriptionLoteprednol Etabonate 0.5%Vehicle of Loteprednol Etabonate
Measure Participants203203
Measure Eyes203203
Number [Eyes]
148
85
Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Loteprednol, Vehicle
Comments
Type of Statistical Test Superiority or Other
Comments
Statistical Test of Hypothesisp-Value<0.001
Comments
MethodChi-squared
Comments
Method of EstimationEstimation ParameterMean Difference (Final Values)
Estimated Value31.0
Confidence Interval (2-Sided) 95%
21.4 to 40.7
Parameter Dispersion Type:
Value:
Estimation Comments

Adverse Events

Time FrameVisit 3 post-operative day 1 thru visit 7 postoperative day 18
Adverse Event Reporting Description
Arm/Group TitleLoteprednolVehicle
Arm/Group DescriptionLoteprednol etabonate 0.5%Vehicle of loteprednol etabonate
All Cause Mortality
LoteprednolVehicle
Affected / at Risk (%)# EventsAffected / at Risk (%)# Events
Total/ (NaN) / (NaN)
Serious Adverse Events
LoteprednolVehicle
Affected / at Risk (%)# EventsAffected / at Risk (%)# Events
Total1/203 (0.5%) 2/203 (1%)
Cardiac disorders
Heart Failure0/203 (0%) 01/203 (0.5%) 1
Eye disorders
Cystoid Macular Edema1/203 (0.5%) 11/203 (0.5%) 1
Respiratory, thoracic and mediastinal disorders
Bronchitis0/203 (0%) 01/203 (0.5%) 1
Other (Not Including Serious) Adverse Events
LoteprednolVehicle
Affected / at Risk (%)# EventsAffected / at Risk (%)# Events
Total0/203 (0%) 0/203 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

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

All study data generated as a result of this study will be regarded as confidential, until appropriate analysis and review by the Sponsor or its designee and the Investigator(s) are completed. The results of the study may be published or presented by the Investigator(s)after the review by, and in consultation and agreement with the Sponsor, and such that confidential or proprietary information is not disclosed.

Results Point of Contact

Name/TitleTuyen Ong, MD, MRCOphth
OrganizationBausch & Lomb Incorporated
Phone(973) 360-6389
Emailtuyen.ong@bausch.com
Responsible Party:
Bausch & Lomb Incorporated
ClinicalTrials.gov Identifier:
NCT01010633
Other Study ID Numbers:
  • 576
First Posted:
Nov 10, 2009
Last Update Posted:
Jan 9, 2012
Last Verified:
Dec 1, 2011