Back to resultsA 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
Primary Purpose
Dry Eye
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Sirolimus
Sirolimus
Sirolimus
Sirolimus
Sponsored by
About this trial
This is an interventional treatment trial for Dry Eye focused on measuring dry eye, sirolimus, rapamycin
Eligibility 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;
Sites / Locations
- Ophthalmic Research Associates
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
Placebo Comparator
Arm Label
Dose Group 1
Dose Group 2
Dose Group 3
Dose Group 4
Arm Description
Outcomes
Primary Outcome Measures
Mean corneal fluorescein staining (inferior region) after CAE exposure.
Mean ocular discomfort during CAE exposure.
Secondary Outcome Measures
Safety across treatment groups.
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.
Full Information
NCT ID
NCT00814944
First Posted
December 23, 2008
Last Updated
January 8, 2013
Sponsor
Santen Inc.
Collaborators
MacuSight, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT00814944
Brief Title
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
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 Type
Interventional
2. Study Status
Record Verification Date
July 2010
Overall Recruitment Status
Completed
Study Start Date
April 2009 (undefined)
Primary Completion Date
October 2009 (Actual)
Study Completion Date
October 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Santen Inc.
Collaborators
MacuSight, Inc.
4. Oversight
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dry Eye
Keywords
dry eye, sirolimus, rapamycin
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
143 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Dose Group 1
Arm Type
Experimental
Arm Title
Dose Group 2
Arm Type
Experimental
Arm Title
Dose Group 3
Arm Type
Experimental
Arm Title
Dose Group 4
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Sirolimus
Other Intervention Name(s)
MS-R001, rapamycin
Intervention Description
Subconjunctival injection of 440 micrograms sirolimus in each eye.
Intervention Type
Drug
Intervention Name(s)
Sirolimus
Other Intervention Name(s)
MS-R003, rapamycin
Intervention Description
Subconjunctival injection of 220 micrograms sirolimus in each eye.
Intervention Type
Drug
Intervention Name(s)
Sirolimus
Other Intervention Name(s)
MS-R002, rapamycin
Intervention Description
Subconjunctival injection of 880 micrograms sirolimus in each eye.
Intervention Type
Drug
Intervention Name(s)
Sirolimus
Intervention Description
Subconjunctival injection of placebo in each eye.
Primary Outcome Measure Information:
Title
Mean corneal fluorescein staining (inferior region) after CAE exposure.
Time Frame
Day 28
Title
Mean ocular discomfort during CAE exposure.
Time Frame
Day 28
Secondary Outcome Measure Information:
Title
Safety across treatment groups.
Time Frame
Through 28 days
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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;
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joel Naor, MD
Organizational Affiliation
MacuSight, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Ophthalmic Research Associates
City
Andover
State/Province
Massachusetts
ZIP/Postal Code
01810
Country
United States
12. IPD Sharing Statement
Learn more about this trial
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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