Phase 3 Study of OTX-101 in the Treatment of Keratoconjunctivitis Sicca

NCT ID: NCT02688556

Last Updated: 2022-08-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 745 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-02-29
• Study Completion Date: 2016-12-31

Brief Summary

This is a randomized, double-masked, vehicle-controlled study of the safety and efficacy of OTX-101 (0.09% cyclosporine nanomicellar solution) in the treatment of keratoconjunctivitis sicca to be conducted at approximately 50 sites.

Conditions

Keratoconjunctivitis Sicca

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

OTX-101 0.09%

0.09% cyclosporine nanomicellar ophthalmic solution

Group Type: EXPERIMENTAL

cyclosporine

Intervention Type: DRUG

Vehicle

vehicle of OTX-101

Group Type: PLACEBO_COMPARATOR

vehicle of OTX-101

Intervention Type: DRUG

Interventions

cyclosporine

Intervention Type: DRUG

vehicle of OTX-101

Intervention Type: DRUG

Other Intervention Names

Seciera

Eligibility Criteria

Inclusion Criteria

• History of dry eye syndrome (KCS) for a period of at least 6 months
• Clinical diagnosis of bilateral KCS
• Lissamine green conjunctival staining sum score of ≥ 3 to ≤ 9 out of a total possible score of 12 (scoring excludes superior zones 2 and 4) in the same eye at both the Screening and Baseline Visits.
• Global symptom score (SANDE) ≥ 40 mm at both the Screening and Baseline Visits
• Corrected Snellen visual acuity (VA) of better than 20/200 in each eye.

Exclusion Criteria

• Use of cyclosporine ophthalmic emulsion 0.05% (Restasis®) within 3 months prior to the Screening Visit.
• Previous treatment failure (lack of efficacy) with cyclosporine ophthalmic emulsion 0.05% (Restasis).
• Diagnosis of Sjögren's disease ˃ 5 years prior to the Screening Visit.
• Clinical diagnosis or any history of seasonal and/or perennial allergic conjunctivitis.
• Use of systemic or topical medications within 7 days prior to the Screening Visit or during the study period that are known to cause dry eye.
• Use of any topical ophthalmic medications, prescription (including anti-glaucoma medications) or over the counter (including artificial tears), other than the assigned study medication during the study period.
• Current active eye disease other than dry wyw syndrome (i.e., any disease for which topical or systemic ophthalmic medication is necessary).
• History of herpes keratitis.
• Corneal transplant
• Corneal refractive surgery within 6 months prior to the Screening Visit or postoperative refractive surgery symptoms of dryness that have not resolved.
• Cataract surgery within 3 months prior to the Screening Visit.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sun Pharmaceutical Industries Limited

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Martel Eye Medical Group

Rancho Cordova, California, United States

Cincinnati Eye Institute

Edgewood, Kentucky, United States

Fifth Avenue Eye Associates

New York, New York, United States

Countries

United States

Other Identifiers

OTX-101-2016-001

Identifier Type: -

Identifier Source: org_study_id