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

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.