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
• Trial end date: 2009-10-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Santen Inc.
• Collaborator: MacuSight, Inc.
• Treatments: Everolimus; Sirolimus

Criteria

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;