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

A Randomized, Multicenter, Double-Masked, Vehicle-Controlled Study of the Safety and Efficacy of OTX-101 in the Treatment of Keratoconjunctivitis Sicca

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.

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.