Skip to main content
OpenTrials
Completed

NCT Number: 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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Dry Eye Dry Eye Syndromes Eye Diseases Lacrimal Apparatus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Ophthalmic Research Associates

Andover, Massachusetts, 01810, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

include, but are not limited to:

  • 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

include, but are not limited to:

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

Treatment and study plan

sirolimus

Drug

Subconjunctival injection of 440 micrograms sirolimus in each eye.

Other names: MS-R001, rapamycin

Primary outcomes

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

    Time frame: Day 28

  2. Mean ocular discomfort during CAE exposure.

    Time frame: Day 28

Secondary outcomes

  1. Safety across treatment groups.

    Time frame: Through 28 days

  2. 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.

    Time frame: Day 28

Sponsors and collaborators

Lead sponsor

Santen Inc.

Industry

Collaborators

  • MacuSight, Inc.

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2009
Study completion
2009
First posted
Dec 25, 2008
Registry last updated
Jan 10, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.