NCT01393132

Comparative Study of Thymosin Beta 4 Eye Drops vs. Vehicle in the Treatment of Severe Dry Eye

Comparative Study of Thymosin Beta 4 Eye Drops or Vehicle in the Treatment of Patients With Ocular Surface Defects Due to Severe Dry Eye

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 9 (actual)
• Sponsor: Michigan Cornea Consultants, PC · Academic / Other
• Sex: All
• Age: 18 Years – 90 Years
• Healthy volunteers: Not accepted

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.

Detailed description

See above

Conditions

• Dry Eye
• Sjogren's Syndrome
• Graft vs. Host Disease

Interventions

Type	Name	Description
DRUG	Thymosin Beta 4 eye drops	Patients will be randomized and will receive the same eye drops the Thymosin Beta 4.
DRUG	Vehicle Control	Patients will be randomized and will receive the same eye drops without the Thymosin Beta 4.

Timeline

• Start date: 2011-03-01
• Primary completion: 2012-12-01
• Completion: 2012-12-01
• First posted: 2011-07-13
• Last updated: 2015-12-23
• Results posted: 2015-12-23

Locations

1 site across 1 country: United States