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TB-500

Thymosin Beta-4, TB4, Tβ4

Quick Stats
Studies 6
Trials 21
Completed PHASE2, PHASE3 INTERVENTIONAL NCT02597803

Assessment of the Safety and Efficacy of RGN-259 Ophthalmic Solutions for Dry Eye Syndrome: ARISE-1

View on ClinicalTrials.gov Updated Dec 15, 2025

Brief Summary

The objective of this study is to compare the safety and efficacy of RGN-259 Ophthalmic Solutions to placebo for the treatment of the signs and symptoms of dry eye.

Detailed Description

Dry eye can be caused by many variable factors. Some examples include hormonal changes due to aging, or living in an environment of low humidity for long periods of time. Dry eye is a complex disease that may result in symptoms like discomfort, visual disturbance, and dryness. Patients with dry eye often have damage on the surface of the eye. In previous studies, RGN-259 has been shown to promote healing of the surface of the eye and decrease inflammation. It suggests that RGN-259 has a significant potential to be an important new safe and effective therapeutic in the treatment of dry eye syndrome.

Interventions

Name: RGN-259
Type: DRUG
Description: A preservative-free, sterile eye drop solution containing Tβ4 for direct instillation into each eye, four times a day (QID) for 28 days
Name: Placebo
Type: DRUG
Description: It is composed of the same excipients as RGN-259 but does not contain Tβ4

Primary Outcomes

Measure: Total corneal fluorescein staining score at day29
TimeFrame: 29 days after first dosing
Description:
Measure: Total ocular discomfort score at day29
TimeFrame: 29 days after first dosing
Description:

Trial Information

NCT ID

NCT02597803

Status

Completed

Study Type

INTERVENTIONAL

Phases

PHASE2, PHASE3

Sponsor

ReGenTree, LLC

Last Updated

December 15, 2025