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

Phase 2

Completed

• Conditions: Dry Eye
• Interventions: Drug: Sirolimus

• Registration Number: NCT00814944
• Lead Sponsor: Santen Inc.

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2008-12-23
• Study First Submitted QC: 2008-12-24
• Study First Posted: 2008-12-25
• Study Start: 2009-04
• Primary Completion: 2009-10
• Study Completion: 2009-10
• Status Verified: 2010-07
• Last Update Submitted: 2013-01-08
• Last Update Posted: 2013-01-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 143

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Dose Group 1	Sirolimus	-
Dose Group 2	Sirolimus	-
Dose Group 3	Sirolimus	-
Dose Group 4	Sirolimus	-

Primary Outcome Measures

Name	Time	Method
Mean corneal fluorescein staining (inferior region) after CAE exposure.	Day 28
Mean ocular discomfort during CAE exposure.	Day 28

Secondary Outcome Measures

Name	Time	Method
Safety across treatment groups.	Through 28 days
Additional evaluations of dry eye including fluorescein staining, lissamine green staining, conjunctival redness, tear film break-up time, blink rate, ocular protection index, Schirmer's Test, and corneal sensitivity.	Day 28

Trial Locations

Locations (1)

Ophthalmic Research Associates; 🇺🇸 Andover, Massachusetts, United States