Safety and Efficacy of Thymosin Beta 4 Ophthalmic Solution in Patients With Dry Eye

What Was Tested

In this phase 2 trial, researchers set out to test TB-500 (Thymosin Beta-4 fragment) and Thymosin Beta-4 (full length).

Thymosin Beta 4 (Tβ4) is a synthetic copy of the naturally-occurring 43-amino acid peptide that is found in a variety of tissues.

Tβ4 promotes/accelerates wound repair in dermal, ocular, and cardiac animal models.

It had two arms (groups): Thymosin Beta 4 (active comparator) and Placebo (placebo comparator).

The placebo solution is composed of the same excipients as RGN-259 but does not contain Tβ4. The Placebo is identical to the RGN-259 eye drops in color, consistency, and odor.

The registry classes the interventions as drug.

More on the Plan

Tβ4 promotes wound repair and regeneration in various tissues.

It up-regulates the gene expression of laminin-5, a major subepithelial adhesion protein, located in the basement membrane region of the cornea, conjunctiva, and important in wound healing.

Who Took Part

The registry lists 72 actual participants took part.

It was open to people of any sex aged from 18 years up to 85 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Have given a written, informed consent. Be able and willing to follow instructions, including participation in study assessments, and be present for the required study visits for the duration of the study. Have a best corrected visual acuity. Have a patient-reported history of dry eye in both eyes. Use and/or desire to use an artificial tear substitute for dry eye symptoms within the past 6 months.

The full record lists 7 inclusion and 9 exclusion criteria; among the exclusions: have contraindications to the use of the study drug; have known allergy or sensitivity to the study drug or components thereof; have anterior blepharitis.

How the Study Was Run

The set-up was randomized, parallel-group and quadruple-blind.

Random assignment meant chance, not the researchers, decided who got TB-500 (Thymosin Beta-4 fragment) and who got the comparison, which limits bias.

The TB-500 (Thymosin Beta-4 fragment) group and the comparison group ran side by side rather than switching.

Blinding on both sides kept the participants and researchers unaware of who received TB-500 (Thymosin Beta-4 fragment).

Those kept unaware of assignments: participant, care provider, investigator and outcomes assessor.

It started in 2011-08 with completion listed for 2011-10.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Ocular Discomfort in the Worst Eye in the Controlled Adverse Environment(CAE) Model, Which is a Regulated Environmental Setting Aimed at Exacerbating the Signs and Symptoms of Dry Eye (time frame: Day 29 (end of treatment)).

It also tracked 1 secondary outcome, for example Number of Adverse Events as a Measure of Safety and Tolerability.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of TB-500 (Thymosin Beta-4 fragment) and Thymosin Beta-4 (full length) in 72 people.

The trial is marked completed; results are posted on the registry, and this page does not restate them.

More context: the TB-500 (Thymosin Beta-4 fragment) compound page and the Thymosin Beta-4 (full length) compound page, all human trials.