Recruiting
PHASE3
INTERVENTIONAL
NCT05555589
Assessment of the Safety and Efficacy of 0.1% RGN-259 Ophthalmic Solution for the Treatment of NK: SEER-2
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 to placebo for the treatment of Neurotrophic Keratopathy (NK)
Detailed Description
Neurotrophic keratopathy (NK) is a degenerative corneal disease that occurs as a result of partial or total impairment of trigeminal innervation. The resulting loss of corneal sensitivity (anesthesia) leads to a reduction in lacrimation and a decline in status, metabolism, and mitosis of corneal epithelial cells.
Interventions
Name:
RGN-259
Type:
DRUG
Description:
A preservative-free, sterile eye drop solution containing TĪ²4 for direct instillation into study eye(s), five times per day for 28 days
Name:
Placebo
Type:
DRUG
Description:
It is composed of the same excipients as RGN-259 but does not contain TĪ²4. Direct instillation into study eye(s), five times per day for 28 days
Primary Outcomes
Measure:
Percentage of subjects achieving complete healing of PED at Day 29
TimeFrame:
Day 29
Description:
Percentage of subjects achieving complete healing of the Persistent Epithelial Defect (PED) at Day 29 determined by corneal fluorescein staining as measured by the Central Reading Center.
Trial Information
NCT ID
NCT05555589
Status
Recruiting
Study Type
INTERVENTIONAL
Phases
PHASE3
Sponsor
ReGenTree, LLC
Last Updated
December 15, 2025