Clinical Research Directory

Inclusion Criteria: 1. 18 years of age or older (regardless of gender). 2. Provide written informed consent. 3. Willing and able to follow instructions and be available for required study visits during the study. 4. Best Corrected Visual Acuity (BCVA) of 20/100 or better in both eyes. 5. Ongoing moderate to severe Dry Eye Disease (DED) supported by a previous clinical diagnosis or a self-reported history of subjective complaints for at least 6 months prior to the screening visit, and meet all the following criteria in at least one eye (the same eye) at Visit 1 and Visit 2: Exclusion Criteria: 1. Known hypersensitivity or contraindication to the study drug or its components. 2. Within 28 days prior to the screening visit (Visit 1), have taken or used: Topical ophthalmic, dermatologic or systemic calcineurin inhibitor (e.g. cyclosporine and tacrolimus), including Restasis® (cyclosporine) and Cequa® (cyclosporine) 3. Current use of contact lenses or anticipated use during the study.