Evaluating Safety and Efficacy of FID 112903 Post Discontinuation of Long-term Use of RESTASIS® (Cyclosporine Ophthalmic Emulsion) 0.05%
This study has been completed.
First Posted: September 10, 2010
Last Update Posted: November 18, 2016
Information provided by (Responsible Party):
The purpose of this study is to evaluate the safety and efficacy of FID 112903 given as an immediate treatment replacement in dry eye subjects that discontinue at least 6 months use of RESTASIS.
|Dry Eye Syndrome||Other: FID 112903 (SYSTANE® ULTRA Lubricant Eye Drops)||Phase 4|
|Study Design:||Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Resource links provided by NLM:
U.S. FDA Resources
Further study details as provided by Alcon Research:
Primary Outcome Measures:
- The change from baseline in Total Corneal Staining. [ Time Frame: 4 months ]
|Study Start Date:||September 2010|
|Study Completion Date:||May 2011|
|Primary Completion Date:||May 2011 (Final data collection date for primary outcome measure)|
Experimental: FID 112903 (SYSTANE® ULTRA Lubricant Eye Drops)
SYSTANE® ULTRA Lubricant Eye Drops dosed 4 times daily
Other: FID 112903 (SYSTANE® ULTRA Lubricant Eye Drops)
Patients will dose 4 times daily for 4 months.
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