['keratoconjunctivitis sicca']
['cyclosporine', 'vehicle of otx-101']

        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.
      