drugset / Trial / NCT01387347

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

NCT01387347 ↗

Phase 2 Completed 72 enrolled ReGenTree, LLC ORA, Inc. · collab
RandomizedParallel-groupQuadruple-blindTreatment

Summary

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. Two recent pre-clinical evaluations have demonstrated that Tβ4 promotes corneal ocular surface defects healing in animal models of dry eye. RGN-259 (formulation of Tβ4 ophthalmic solution) mechanism of action offers potential to be a product that meets a major unmet medical need in patients with dry eye.

Timeline

Start
2011-08
Primary completion
2011-10
Completion
2011-12

Drugs

EvaluationDrugModalityDoseRoute
Comparator Thymosin Beta 4 Peptide 0.1 % Topical

Indications