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
Status: | Completed |
---|---|
Conditions: | Ocular |
Therapuetic Areas: | Ophthalmology |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 10/14/2017 |
Start Date: | April 2009 |
End Date: | October 2009 |
A Phase 2, Multi-Center, Randomized, Double-Masked, Placebo-Controlled, 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
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.
(rapamycin) formulation compared to Placebo on the signs and symptoms of dry eye in the CAE
Model.
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;
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