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

Stopped early · Phase 2 · Has a placebo group

Conditions studied: Dry Eye Syndromes

In brief

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.

Key facts

Study ID

NCT02013791

Run by

Allergan

People needed

55

Starts

2014-04-29

Expected to finish

2017-04-12

Last updated by the study team

2018-05-15

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

• 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

Where it is running

• Sall Research Medical Center — Artesia, California, United States
• Lugene Eye Institute — Glendale, California, United States
• Lakeside Vision Center — Irvine, California, United States
• Steve Yoelin MD Medical Asscociates — Newport Beach, California, United States
• Wolstan & Goldberg Eye Associates — Torrance, California, United States
• Vision Institute — Colorado Springs, Colorado, United States
• Johns Hopkins University - Wilmer Eye Institute — Baltimore, Maryland, United States
• Eye Centers of Racine and Kenosha — Kenosha, Wisconsin, United States

Full record on ClinicalTrials.gov

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