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

Santen Inc.1 site in 1 country143 target enrollmentApril 2009

ConditionsDry Eye

InterventionsSirolimus

DrugsSirolimus

Overview

Phase: Phase 2
Intervention: Sirolimus
Conditions: Dry Eye
Sponsor: Santen Inc.
Enrollment: 143
Locations: 1
Primary Endpoint: Mean corneal fluorescein staining (inferior region) after CAE exposure.
Status: Completed
Last Updated: 13 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

April 2009

End Date

October 2009

Last Updated

13 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Santen Inc.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Arms & Interventions

Dose Group 1

Intervention: Sirolimus

Dose Group 2

Intervention: Sirolimus

Dose Group 3

Intervention: Sirolimus

Dose Group 4

Intervention: Sirolimus

Outcomes

Primary Outcomes

Mean corneal fluorescein staining (inferior region) after CAE exposure.

Time Frame: Day 28

Mean ocular discomfort during CAE exposure.

Time Frame: Day 28

Secondary Outcomes

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)