Effect of Cequa Treatment on Accuracy of Pre-operative Biometry & Higher Order Aberrations in Dry Eye Patients Undergoing Cataract Surgery

Sponsor
Research Insight LLC (Industry)
Overall Status
Completed
CT.gov ID
NCT04342988
Collaborator
(none)
74
3
1
8.8
24.7
2.8

Study Details

Study Description

Brief Summary

The purpose of this study is to examine the effect of Cequa treatment on the accuracy of pre-operative biometry and on corneal higher-order aberrations (HOAs) in cataract patients who have signs of dry eye disease.

Condition or Disease Intervention/Treatment Phase
Phase 4

Detailed Description

Hypothesis: In patients with dry eye, defined as corneal staining and a reduced tear breakup time, the accuracy of pre-operative biometry and corneal surface HOAs will improve significantly after four weeks of Cequa treatment.

Primary Outcome Measure: Spherical equivalent prediction error of pre-Cequa vs post-Cequa ocular biometry performed for cataract surgery.

Secondary Outcome Measures:

The impact of Cequa treatment on corneal higher order aberrations measured in the central 6 mm of the cornea.

The difference in SPEED questionnaire scores before and 4 weeks after Cequa treatment.

The difference in corneal staining and tear breakup time (TBUT) before and after treatment with Cequa.

Study Design

Study Type:
Interventional
Actual Enrollment :
74 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Effect of Cequa Treatment on Accuracy of Pre-operative Biometry and Higher Order Aberrations in Dry Eye Patients Undergoing Cataract Surgery
Actual Study Start Date :
Apr 8, 2020
Actual Primary Completion Date :
Dec 31, 2020
Actual Study Completion Date :
Dec 31, 2020

Arms and Interventions

Arm Intervention/Treatment
Other: Cequa Treatment In Cataract Patients with Dry Eye Disease

Duration of Study Treatment - 4 weeks All patients will receive cyclosporine ophthalmic solution (0.09%) BID in both eyes for 28 days, 1 drop per dose. Dosing will be BID, both eyes, assuming both eyes will eventually undergo cataract surgery. Otherwise, single eye treatment in the operative eye will be permitted.

Drug: Cequa
The effect of Cequa treatment on the accuracy of pre-operative biometry and on corneal higher-order aberrations (HOAs) in cataract patients who have signs of dry eye disease.

Outcome Measures

Primary Outcome Measures

  1. Spherical equivalent prediction error of pre-Cequa vs post-Cequa ocular biometry performed for cataract surgery. [Four weeks]

Secondary Outcome Measures

  1. The impact of Cequa treatment on corneal higher order aberrations measured in the central 6 mm of the cornea. [Four Weeks]

  2. The difference in SPEED questionnaire scores before and 4 weeks after Cequa treatment. [Four Weeks]

    To compare the difference in Standard Patient of Eye Dryness Questionnaire (SPEED) scores before and after 4 weeks of therapy with Cequa BID among patients with significant dry eye (decreased TBUT or corneal staining) with planned cataract surgery. The SPEED questionnaire gives a score from 0-28 that is the result of 8 items that assess frequency and severity of symptoms. Speed Score Severity rating: 0-4 Mild, 5-7 Moderate, 8+ Severe.

  3. The difference in corneal staining before and after treatment with Cequa. [Four Weeks]

    The presence of central or inferior corneal fluorescein staining defined by the Oxford Scale.

  4. The difference in tear breakup time (TBUT) before and after treatment with Cequa. [Four Weeks]

    Reduced tear break up time (TBUT) ≤ 10 seconds.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  • Patients with planned cataract surgery,

  • The presence of central or inferior corneal fluorescein staining defined by the Oxford Scale

  • Reduced tear break up time (TBUT) ≤ 10 seconds.

  • Able to comprehend and sign a statement of informed consent.

  • Willing and able to complete all required postoperative visits.

Exclusion Criteria:
  • Ocular surgery (e.g., intraocular, oculoplastic, corneal or refractive surgical procedure) performed within the last 3 months or at any time that in the investigator's clinical judgment if it would interfere with the outcome measures of this study.

  • Clinically significant ocular trauma.

  • Active ocular Herpes simplex or Herpes Zoster infection

  • Ocular inflammation (uveitis, iritis, scleritis, episcleritis, keratitis, conjunctivitis) at the discretion of the investigator.

  • Ocular infection (e.g., viral, bacterial, mycobacterial, protozoan or fungal infection or the cornea, conjunctiva, lacrimal gland, lacrimal sac or eyelids including hordeolum/stye).

  • Active, systemic or local disease condition that causes clinically significant ocular surface irritation such that it could interfere with the study findings.

  • Moderate to severe (Grade 2-4) allergic, vernal or giant papillary conjunctivitis.

  • Severe (Grade 3 or 4) inflammation of the eyelid (e.g., blepharochalasis, staphylococcal blepharitis or seborrheic blepharitis)

  • Eyelid abnormalities that significantly affect the lid function (e.g., entropion, ectropion, tumor, edema, blepharospasm, lagophthalmos, severe trichiasis, severe ptosis).

  • Ocular surface abnormality that may compromise the corneal integrity (e.g., prior chemical burn, recurrent corneal erosion, corneal epithelial defect, Grade 3 corneal fluorescein staining, map dot fingerprint dystrophy, or the effect of any other ophthalmic medication that might in the opinion of the investigator compromise the ocular surface integrity).

  • Participation in this trial in the same patient's fellow eye

  • Patients who are under age 18, pregnant or breastfeeding, or who may become pregnant during participation in the study.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Harvard Eye Associates Laguna Hills California United States 92653
2 Ophthalmology Associates Saint Louis Missouri United States 63131
3 Ophthalmic Surgeons & Consultants of Ohio Columbus Ohio United States 43215

Sponsors and Collaborators

  • Research Insight LLC

Investigators

  • Study Director: John Hovanesian, MD, Research Insight LLC

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Research Insight LLC
ClinicalTrials.gov Identifier:
NCT04342988
Other Study ID Numbers:
  • Sun Cequa Accuracy 191118
First Posted:
Apr 13, 2020
Last Update Posted:
Mar 12, 2021
Last Verified:
Apr 1, 2020
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Product Manufactured in and Exported from the U.S.:
Yes
Additional relevant MeSH terms:

Study Results

No Results Posted as of Mar 12, 2021