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

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.