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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

Sponsor
Santen Inc. (Industry)
Overall Status
Completed
CT.gov ID
NCT00814944
Collaborator
MacuSight, Inc. (Industry)
143
Enrollment
1
Location
4
Arms
6
Duration (Months)
23.8
Patients Per Site Per Month

Study Details

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
Phase 2

Study Design

Study Type:
Interventional
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 :
Apr 1, 2009
Actual Primary Completion Date :
Oct 1, 2009
Actual Study Completion Date :
Oct 1, 2009

Arms and Interventions

Arm Intervention/Treatment
Experimental: Dose Group 1

Drug: Sirolimus
Subconjunctival injection of 220 micrograms sirolimus in each eye.
Other Names:
  • MS-R003, rapamycin

    		•
    Experimental: Dose Group 2

    Drug: Sirolimus
    Subconjunctival injection of 440 micrograms sirolimus in each eye.
    Other Names:
  • MS-R001, rapamycin

    		•
    Experimental: Dose Group 3

    Drug: Sirolimus
    Subconjunctival injection of 880 micrograms sirolimus in each eye.
    Other Names:
  • 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. [Day 28]

    2. Mean ocular discomfort during CAE exposure. [Day 28]

    Secondary Outcome Measures

    1. Safety across treatment groups. [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. [Day 28]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Locations

    Site City State Country Postal Code
    1 Ophthalmic Research Associates Andover Massachusetts United States 01810

    Sponsors and Collaborators

    • Santen Inc.
    • MacuSight, Inc.

    Investigators

    • Study Director: Joel Naor, MD, MacuSight, Inc.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Santen Inc.
    ClinicalTrials.gov Identifier:
    NCT00814944
    Other Study ID Numbers:
    • DES-001
    First Posted:
    Dec 25, 2008
    Last Update Posted:
    Jan 10, 2013
    Last Verified:
    Jul 1, 2010
    Keywords provided by Santen Inc.
    dry eye
    sirolimus
    rapamycin
    Additional relevant MeSH terms:
    Dry Eye Syndromes
    Keratoconjunctivitis Sicca
    Sirolimus

    Study Results

    No Results Posted as of Jan 10, 2013