Treatment Safety and Efficacy of Pro-ocular™ 1% for Chronic Ocular Graft Following Allogeneic HSCT.

Phase 2 Completed 33 enrolled Glia, LLC ORA, Inc. · collab

RandomizedParallel-groupQuadruple-blindTreatment

Summary

To evaluate the safety and efficacy of Pro-ocular™ 1% topical gel administered twice daily for 70 days in reducing or eliminating symptoms and signs of chronic ocular GvHD.

Timeline

Start: 2019-10-17
Primary completion: 2021-10-31
Completion: 2021-11-19

Outcome

Met primary endpoint

registry LEAST_SQUARES_MEAN Pro-ocular™: -22.00 (Standard Error 4.246) score on a scale NCT03990051 ↗

registry analysis (superiority test); Pro-ocular™ vs Placebo; p = 0.0197; Mixed Models Analysis NCT03990051 ↗

registry LEAST_SQUARES_MEAN Pro-ocular™: -0.90 (Standard Error 0.213) score on a scale NCT03990051 ↗

registry analysis (superiority test); Pro-ocular™ vs Placebo; p = 0.0039; Mixed Models Analysis NCT03990051 ↗

Publications

Results Luo ZK, Domenech-Estarellas EA, Han A, Lee D, Khatri R, Wahl JL, Cutler C, Armand P, Antin JH, Koreth J, Gooptu M, Alyea EP, Soiffer RJ, Ho VT. Efficacy and Safety of 1% Progesterone Gel to the Forehead for Ocular Chronic Graft-versus-Host Disease. Transplant Cell Ther. 2021 May;27(5):433.e1-433.e8. doi: 10.1016/j.jtct.2021.02.008. Epub 2021 Feb 14.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Progesterone	Other / unclassified	1 %	Topical