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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

This study has been completed.
Sponsor:
Collaborator:
MacuSight, Inc.
Information provided by (Responsible Party):
Santen Inc.
ClinicalTrials.gov Identifier:
NCT00814944
First received: December 23, 2008
Last updated: January 8, 2013
Last verified: July 2010
History of Changes
  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 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Santen 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 ]

Enrollment: 143
Study Start Date: April 2009
Study Completion Date: October 2009
Primary Completion Date: October 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  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

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

No publications provided

Responsible Party: Santen Inc.
ClinicalTrials.gov Identifier: NCT00814944     History of Changes
Other Study ID Numbers: DES-001
Study First Received: December 23, 2008
Last Updated: January 8, 2013
Health Authority: United States: Food and Drug Administration

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
 Antibiotics, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Antifungal Agents
Anti-Infective Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Anti-Bacterial Agents

ClinicalTrials.gov processed this record on June 18, 2013