Expired Study
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Southfield, Michigan 48034


Purpose:

Severe dry eye is a debilitating ocular disease resulting in loss of vision, reduced day-to-day function and significant discomfort. Tear substitutes are an important part of the treatment of all patients, however, even with aggressive us, the corneal(ocular)surface often remains very irregular due to poor surface healing. The agent being evaluated in this study, Thymosin Beta 4, promotes healing of the corneal surface and has been studied in patients with recalcitrant corneal ulcers and erosions with significant success (Arch Ophthalmol. 2010;128(5):636-638., Ann of the NY Acad of Sci, May, 2010). The study hypothesis is that Thymosin Beta 4, in its role as a modulator of corneal surface healing, may be able to promote healing of the corneal surface allowing for more conventional modalities to take over and maintain a smooth and regular ocular surface. The investigators hope to be able to demonstrate an improvement in visual acuity, surface healing and a reduction in dry-eye related symptoms.


Study summary:

See above


Criteria:

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


NCT ID:

NCT01393132


Primary Contact:

Principal Investigator
Steven P Dunn, M.D.
Michigan Cornea Consultants, P.C.


Backup Contact:

N/A


Location Contact:

Southfield, Michigan 48034
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: August 31, 2019

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