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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT00814944 |
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Date of registration:
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23/12/2008 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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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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Scientific title:
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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 |
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Date of first enrolment:
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April 2009 |
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Target sample size:
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143 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00814944 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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Phase:
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Phase 2
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Countries of recruitment
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United States
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Contacts
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Name:
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Joel Naor, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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MacuSight, Inc. |
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Key inclusion & exclusion criteria
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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;
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Dry Eye
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Intervention(s)
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Drug: Sirolimus
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Primary Outcome(s)
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Mean ocular discomfort during CAE exposure.
[Time Frame: Day 28]
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Mean corneal fluorescein staining (inferior region) after CAE exposure.
[Time Frame: Day 28]
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Secondary Outcome(s)
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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]
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Safety across treatment groups.
[Time Frame: Through 28 days]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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