drugset / Trial / NCT02597803

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

NCT02597803 ↗

Phase 2/3 Completed 317 enrolled ReGenTree, LLC
RandomizedParallel-groupQuadruple-blindTreatment

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.

Timeline

Start
2015-09
Primary completion
2016-06
Completion
2016-07

Outcome

Met primary endpoint

release “In a recently completed Phase 2 clinical trial in 72 patients with moderate dry eye syndrome, RGN-259 was found to show statistically significant improvements” regenerx.com ↗

release “Based on U.S. Phase 2 and Phase 2b/3 clinical trials in moderate and severe dry eye syndrome, RGN-259 was found to show statistically significant improvements” regenerx.com ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject RGN-259 Unknown — Topical

Indications