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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

NCT00814944 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 143

Last updated 2013-01-10

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • MacuSight, Inc.

    collaborator INDUSTRY

  • Santen Inc.

    lead INDUSTRY

Principal Investigators

  • Joel Naor, MD · MacuSight, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-04-30
Primary Completion
2009-10-31
Completion
2009-10-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00814944 on ClinicalTrials.gov