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

Completed · Phase 3

Conditions studied: Keratoconjunctivitis Sicca

In brief

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.

Key facts

Study ID

NCT02688556

Run by

Sun Pharmaceutical Industries Limited

People needed

745

Starts

2016-02-01

Expected to finish

2016-12-01

Last updated by the study team

2022-08-29

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• 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

Full record on ClinicalTrials.gov

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