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

Dry Eye Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00814944
• Other study ID #: DES-001
• Status: Completed
• Phase: Phase 2
• First received: December 23, 2008
• Last updated: January 8, 2013
• Start date: April 2009
• Est. completion date: October 2009

Study information

• Verified date: July 2010
• Source: Santen Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 143
• Est. completion date: October 2009
• Est. primary completion date: October 2009
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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;

Related Conditions & MeSH terms

• Dry Eye
• Dry Eye Syndromes
• Keratoconjunctivitis Sicca

Intervention

Drug:
• Sirolimus
Subconjunctival injection of 440 micrograms sirolimus in each eye.
• Sirolimus
Subconjunctival injection of 220 micrograms sirolimus in each eye.
• Sirolimus
Subconjunctival injection of 880 micrograms sirolimus in each eye.
• Sirolimus
Subconjunctival injection of placebo in each eye.

Locations

Country	Name	City	State
United States	Ophthalmic Research Associates	Andover	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Santen Inc.	MacuSight, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean corneal fluorescein staining (inferior region) after CAE exposure.		Day 28
Primary	Mean ocular discomfort during CAE exposure.		Day 28
Secondary	Safety across treatment groups.		Through 28 days
Secondary	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