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TB-500

Thymosin Beta-4, TB4, Tβ4

Quick Stats
Studies 6
Trials 21
Completed PHASE2 INTERVENTIONAL NCT01393132

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

View on ClinicalTrials.gov Updated Dec 15, 2025

Brief 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

Interventions

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

Primary Outcomes

Measure: Safety
TimeFrame: Day 1, Day 14, Day 28 and Day 56
Description: Sum of adverse events observed at Day 1, Day 14, Day 28 and Day 56. Measurable by Intra-ocular pressure (IOP) by applanation tonometry, Complete ophthalmologic evaluation including fundoscopy, An adverse event (baseline and all subsequent study visits).

Trial Information

NCT ID

NCT01393132

Status

Completed

Study Type

INTERVENTIONAL

Phases

PHASE2

Sponsor

Michigan Cornea Consultants, PC

Last Updated

December 15, 2025