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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

143 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-04-30

Study Completion Date

2009-10-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Dry Eye

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Subconjunctival injection of 440 micrograms sirolimus in each eye.

Intervention Type DRUG

Sirolimus

Subconjunctival injection of 220 micrograms sirolimus in each eye.

Intervention Type DRUG

Sirolimus

Subconjunctival injection of 880 micrograms sirolimus in each eye.

Intervention Type DRUG

Sirolimus

Subconjunctival injection of placebo in each eye.

Intervention Type DRUG

Other Intervention Names

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MS-R001, rapamycin MS-R003, rapamycin MS-R002, rapamycin

Eligibility Criteria

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Inclusion Criteria

* 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

* Have contraindications to the use of the study medications;
* Have known allergy or sensitivity to the use of the study medications or diagnostic dyes;

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No