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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 October 2017 |
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Main ID: |
NCT01393132 |
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Date of registration:
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07/07/2011 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Comparative Study of Thymosin Beta 4 Eye Drops vs. Vehicle in the Treatment of Severe Dry Eye
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Scientific title:
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Comparative Study of Thymosin Beta 4 Eye Drops or Vehicle in the Treatment of Patients With Ocular Surface Defects Due to Severe Dry Eye |
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Date of first enrolment:
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March 2011 |
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Target sample size:
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9 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT01393132 |
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Study type:
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Interventional |
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Study design:
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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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Steven P Dunn, M.D. |
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Address:
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Telephone:
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Email:
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Affiliation:
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Michigan Cornea Consultants, P.C. |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Schirmers of < 5 mm at 5 minutes
- TFBUT: less than 10 seconds
- Corneal staining of >3 of 15: conjunctival staining of >3 of 18
- Ocular Surface Disease Index of > 50
- Presumed best corrected vision of 20/60 or better
Exclusion Criteria:
- Acute or inflammatory corneal disease
- Pregnancy or lactation
- Monocular status
- Punctal occlusion within 30 days
- Ocular surgery within 3 months
- Corneal thinning of >50%
- Active corneal infection
- History of ocular malignancy
- Retinal neovascularization
- Current use of topical cyclosporin A
Age minimum:
18 Years
Age maximum:
90 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Graft vs. Host Disease
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Sjogren's Syndrome
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Dry Eye
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Intervention(s)
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Drug: Thymosin Beta 4 eye drops
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Drug: Vehicle Control
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Primary Outcome(s)
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Safety
[Time Frame: Day 1, Day 14, Day 28 and Day 56]
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Secondary Outcome(s)
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Tear Film Break up Time
[Time Frame: Days 56 (+28 day follow up)]
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Corneal Fluorescein Staining
[Time Frame: Days 56 (+28 day follow up)]
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Ocular Discomfort Index
[Time Frame: Days 56 (+28 day follow up)]
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Secondary ID(s)
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1003008179
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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