Completed
PHASE3
INTERVENTIONAL
NCT03937882
Assessment of the Safety and Efficacy of RGN-259 Ophthalmic Solutions for Dry Eye Syndrome: ARISE-3
View on ClinicalTrials.gov
Updated Dec 15, 2025
Brief Summary
The objective of this study is to compare the safety and efficacy of RGN-259 Ophthalmic Solution to placebo for the treatment of the signs and symptoms of dry eye.
Interventions
Name:
RGN-259
Type:
DRUG
Description:
A preservative-free, sterile eye drop solution containing Thymosin beta 4 for direct instillation into each eye, four times a day (QID) for 14 days
Name:
Placebo
Type:
DRUG
Description:
It is composed of the same excipients as RGN-259 but does not contain Thymosin beta 4
Primary Outcomes
Measure:
Corneal staining
TimeFrame:
15 days after first dosing
Description:
Mean change from baseline to Day 15 of Inferior Corneal Fluorescein Staining
Measure:
Ocular Discomfort 6-point (0=none, 5=worst) scale
TimeFrame:
15 days after first dosing
Description:
Mean change from baseline to Day 15 of Ocular Discomfort severity
Trial Information
NCT ID
NCT03937882
Status
Completed
Study Type
INTERVENTIONAL
Phases
PHASE3
Sponsor
ReGenTree, LLC
Last Updated
December 15, 2025