Status:
COMPLETED
A Dose-Ranging Clinical Study to Assess the Safety and Efficacy of Subconjunctival Injection of Sirolimus in Patients With Dry Eye in the Controlled Adverse Environmental (CAE) Model
Lead Sponsor:
Santen Inc.
Collaborating Sponsors:
MacuSight, Inc.
Conditions:
Dry Eye
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The purpose of this study is to determine the safety and efficacy of an ocular sirolimus (rapamycin) formulation compared to Placebo on the signs and symptoms of dry eye in the CAE Model.
Eligibility Criteria
Inclusion
- Inclusion Criteria include, but are not limited to:
- Have a reported history of dry eye in both eyes;
- Have a history of use of or desire to use an eye drop for dry eye symptoms within the past 6 months.
- Exclusion Criteria include, but are not limited to:
- Have contraindications to the use of the study medications;
- Have known allergy or sensitivity to the use of the study medications or diagnostic dyes;
Exclusion
Key Trial Info
Start Date :
April 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2009
Estimated Enrollment :
143 Patients enrolled
Trial Details
Trial ID
NCT00814944
Start Date
April 1 2009
End Date
October 1 2009
Last Update
January 10 2013
Active Locations (1)
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1
Ophthalmic Research Associates
Andover, Massachusetts, United States, 01810