Phase 2 Study of a New Ophthalmic Formulation of Cyclosporine (Restasis® X) in Patients With Dry Eye Disease
| Status: | Terminated |
|---|---|
| Conditions: | Ocular |
| Therapuetic Areas: | Ophthalmology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 5/17/2018 |
| Start Date: | April 29, 2014 |
| End Date: | April 12, 2017 |
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.
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
We found this trial at
8
sites
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