Comparative Study of Thymosin Beta 4 Eye Drops vs. Vehicle in the Treatment of Severe Dry Eye
Registered Phase 2 interventional trial (completed), with sponsor-posted results. 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
Registered clinical trial record on ClinicalTrials.gov (NCT01393132). This describes a planned, ongoing, or completed study — it is NOT peer-reviewed results, though the sponsor has posted summary results. Status: completed. Study type: interventional. Phase: Phase 2. Sponsor: Michigan Cornea Consultants, PC. Conditions: Dry Eye, Sjogren's Syndrome, Graft vs. Host Disease. Interventions: Thymosin Beta 4 eye drops, Vehicle Control. Summary: 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. See above Primary outcome measures: Safety. Eligibility: 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
This is a registered clinical-trial record from ClinicalTrials.gov — a description of a planned, ongoing, or completed study, not peer-reviewed results. Listing on ClinicalTrials.gov does not mean the study has been evaluated by the U.S. Federal Government, nor does it imply endorsement or that the intervention is safe or effective.
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