Phase 2 Study of a New Ophthalmic Formulation of Cyclosporine (Restasis® X) in Patients With Dry Eye Disease

A Phase 2, Multi-center, Vehicle- and Sham-controlled, Randomized Study of RESTASIS® X in Patients With Moderate to Severe Dry Eye Disease

This study will evaluate a new ophthalmic formulation of cyclosporine (Restasis® X) in patients with moderate to severe dry eye disease in two stages. Up to 3 doses will be studied in Stage 2 based on results from Stage 1. No patients participating in Stage 1 will participate in Stage 2 of this study. This study was terminated and Stage 2 of the study was cancelled.

Inclusion Criteria:

• Moderate to severe dry eye disease in both eyes
• Best-corrected visual acuity (BCVA) of 20/100 or better in each eye

Exclusion Criteria:

• Use of any cyclosporine preparations within 3 months
• Use of topical medications, other than artificial tears, in the eyes within 1 month
• Use of contact lenses in either eye within 1 month
• Stage 2 only: Participation in Stage 1 of this study