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 - Full Text View

Sponsored by:	MacuSight, Inc.
Information provided by:	MacuSight, Inc.
ClinicalTrials.gov Identifier:	NCT00814944

Purpose

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.

Condition	Intervention	Phase
Dry Eye	Drug: Sirolimus	Phase II

Drug Information available for: Sirolimus

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study
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

Further study details as provided by MacuSight, Inc.:

Primary Outcome Measures:

Mean corneal fluorescein staining (inferior region) after CAE exposure. [ Time Frame: Day 28 ] [ Designated as safety issue: No ]
Mean ocular discomfort during CAE exposure. [ Time Frame: Day 28 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Safety across treatment groups. [ Time Frame: Through 28 days ] [ Designated as safety issue: Yes ]
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 ] [ Designated as safety issue: No ]

Estimated Enrollment:	150
Study Start Date:	February 2009
Estimated Study Completion Date:	October 2009
Estimated Primary Completion Date:	October 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Dose Group 1: Experimental	Drug: Sirolimus Subconjunctival injection of 220 micrograms sirolimus in each eye.
Dose Group 2: Experimental	Drug: Sirolimus Subconjunctival injection of 440 micrograms sirolimus in each eye.
Dose Group 3: Experimental	Drug: Sirolimus Subconjunctival injection of 880 micrograms sirolimus in each eye.
Dose Group 4: Placebo Comparator	Drug: Sirolimus Subconjunctival injection of placebo in each eye.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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;

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00814944

Contacts

Contact: Celine Delpouys

510-400-1427

cdelpouys@macusight.com

Sponsors and Collaborators

MacuSight, Inc.

Investigators

Study Director:

Joel Naor, MD

MacuSight, Inc.

More Information

Responsible Party:	MacuSight ( Kathy Jensen/Director of Clinical Operations )
Study ID Numbers:	DES-001
Study First Received:	December 23, 2008
Last Updated:	December 24, 2008
ClinicalTrials.gov Identifier:	NCT00814944
Health Authority:	United States: Food and Drug Administration

Keywords provided by MacuSight, Inc.:

dry eye, sirolimus, rapamycin

Study placed in the following topic categories:

Sirolimus
Clotrimazole
Miconazole
Tioconazole

Additional relevant MeSH terms:

Anti-Bacterial Agents
Anti-Infective Agents
Immunologic Factors
Antineoplastic Agents
Antifungal Agents

Therapeutic Uses
Physiological Effects of Drugs
Antibiotics, Antineoplastic
Immunosuppressive Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 15, 2009