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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

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ClinicalTrials.gov Identifier: NCT00814944
Recruitment Status : Completed
First Posted : December 25, 2008
Last Update Posted : January 10, 2013
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
Brief 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.

Condition or disease Intervention/treatment Phase
Dry Eye Drug: Sirolimus Phase 2

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 143 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Study Start Date : April 2009
Primary Completion Date : October 2009
Study Completion Date : October 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eye Care
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Dose Group 1 Drug: Sirolimus
Subconjunctival injection of 220 micrograms sirolimus in each eye.
Other Name: MS-R003, rapamycin
Experimental: Dose Group 2 Drug: Sirolimus
Subconjunctival injection of 440 micrograms sirolimus in each eye.
Other Name: MS-R001, rapamycin
Experimental: Dose Group 3 Drug: Sirolimus
Subconjunctival injection of 880 micrograms sirolimus in each eye.
Other Name: MS-R002, rapamycin
Placebo Comparator: Dose Group 4 Drug: Sirolimus
Subconjunctival injection of placebo in each eye.


Outcome Measures

Primary Outcome Measures :
  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 Outcome Measures :
  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 ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00814944


Locations
United States, Massachusetts
Ophthalmic Research Associates
Andover, Massachusetts, United States, 01810
Sponsors and Collaborators
Santen Inc.
MacuSight, Inc.
Investigators
Study Director: Joel Naor, MD MacuSight, Inc.
More Information

Responsible Party: Santen Inc.
ClinicalTrials.gov Identifier: NCT00814944     History of Changes
Other Study ID Numbers: DES-001
First Posted: December 25, 2008    Key Record Dates
Last Update Posted: January 10, 2013
Last Verified: July 2010

Keywords provided by Santen Inc.:
dry eye
sirolimus
rapamycin

Additional relevant MeSH terms:
Keratoconjunctivitis Sicca
Dry Eye Syndromes
Keratoconjunctivitis
Conjunctivitis
Conjunctival Diseases
Eye Diseases
Keratitis
Corneal Diseases
Lacrimal Apparatus Diseases
Sirolimus
Everolimus
Anti-Bacterial Agents
Anti-Infective Agents
Antibiotics, Antineoplastic
Antineoplastic Agents
Antifungal Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs