NCT00814944

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

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 143 (actual)
• Sponsor: Santen Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Dry Eye

Interventions

Type	Name	Description
DRUG	Sirolimus	Subconjunctival injection of 440 micrograms sirolimus in each eye.
DRUG	Sirolimus	Subconjunctival injection of 220 micrograms sirolimus in each eye.
DRUG	Sirolimus	Subconjunctival injection of 880 micrograms sirolimus in each eye.
DRUG	Sirolimus	Subconjunctival injection of placebo in each eye.

Timeline

• Start date: 2009-04-01
• Primary completion: 2009-10-01
• Completion: 2009-10-01
• First posted: 2008-12-25
• Last updated: 2013-01-10

Locations

1 site across 1 country: United States