Assessment of the Safety and Efficacy Study of RGN-259 Ophthalmic Solutions for Neurotrophic Keratopathy : SEER-1

Summary

The objective of this study is to assess the safety and efficacy of RGN-259 Ophthalmic Solution compared to placebo for the treatment of NK.

Timeline

Start

2015-09-17

Primary completion

2019-11-20

Completion

2020-03-09

Outcome

Missed primary endpoint

Stopped (Business): “Business decision”

release “the patients and treating physicians remain masked while the trial is on-going, so it is not known whether the healed patients are in the RGN-259 group” reads as unknown regenerx.com ↗

release “In terms of the primary endpoint, the "ratio of corneal wound healed patients after four weeks' administration", the statistical difference was slightly over 0.05” reads as missed primary endpoint regenerx.com ↗

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	RGN-259	Unknown	—	Other

Indications