- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00814944
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
January 8, 2013 updated by: Santen Inc.
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
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
143
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Massachusetts
-
Andover, Massachusetts, United States, 01810
- Ophthalmic Research Associates
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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;
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: TRIPLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Dose Group 1
|
Subconjunctival injection of 440 micrograms sirolimus in each eye.
Other Names:
Subconjunctival injection of 220 micrograms sirolimus in each eye.
Other Names:
Subconjunctival injection of 880 micrograms sirolimus in each eye.
Other Names:
Subconjunctival injection of placebo in each eye.
|
EXPERIMENTAL: Dose Group 2
|
Subconjunctival injection of 440 micrograms sirolimus in each eye.
Other Names:
Subconjunctival injection of 220 micrograms sirolimus in each eye.
Other Names:
Subconjunctival injection of 880 micrograms sirolimus in each eye.
Other Names:
Subconjunctival injection of placebo in each eye.
|
EXPERIMENTAL: Dose Group 3
|
Subconjunctival injection of 440 micrograms sirolimus in each eye.
Other Names:
Subconjunctival injection of 220 micrograms sirolimus in each eye.
Other Names:
Subconjunctival injection of 880 micrograms sirolimus in each eye.
Other Names:
Subconjunctival injection of placebo in each eye.
|
PLACEBO_COMPARATOR: Dose Group 4
|
Subconjunctival injection of 440 micrograms sirolimus in each eye.
Other Names:
Subconjunctival injection of 220 micrograms sirolimus in each eye.
Other Names:
Subconjunctival injection of 880 micrograms sirolimus in each eye.
Other Names:
Subconjunctival injection of placebo in each eye.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Mean corneal fluorescein staining (inferior region) after CAE exposure.
Time Frame: Day 28
|
Day 28
|
Mean ocular discomfort during CAE exposure.
Time Frame: Day 28
|
Day 28
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Safety across treatment groups.
Time Frame: Through 28 days
|
Through 28 days
|
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
|
Day 28
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
April 1, 2009
Primary Completion (ACTUAL)
October 1, 2009
Study Completion (ACTUAL)
October 1, 2009
Study Registration Dates
First Submitted
December 23, 2008
First Submitted That Met QC Criteria
December 24, 2008
First Posted (ESTIMATE)
December 25, 2008
Study Record Updates
Last Update Posted (ESTIMATE)
January 10, 2013
Last Update Submitted That Met QC Criteria
January 8, 2013
Last Verified
July 1, 2010
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Eye Diseases
- Lacrimal Apparatus Diseases
- Keratoconjunctivitis
- Conjunctivitis
- Conjunctival Diseases
- Keratitis
- Corneal Diseases
- Dry Eye Syndromes
- Keratoconjunctivitis Sicca
- Physiological Effects of Drugs
- Anti-Infective Agents
- Antineoplastic Agents
- Immunosuppressive Agents
- Immunologic Factors
- Anti-Bacterial Agents
- Antibiotics, Antineoplastic
- Antifungal Agents
- Sirolimus
Other Study ID Numbers
- DES-001
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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