Terminated
PHASE3
INTERVENTIONAL
NCT02600429
Assessment of the Safety and Efficacy Study of RGN-259 Ophthalmic Solutions for Neurotrophic Keratopathy : SEER-1
View on ClinicalTrials.gov
Updated Dec 15, 2025
Brief 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.
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. Previous studies (physician-sponsored studies) used to treat to nine patients with NK, six of whom had discrete geographic, non-healing lesions, and three of whom had punctate lesions and the study result reported.
Interventions
Name:
RGN-259
Type:
DRUG
Description:
A preservative-free, sterile eye drop solution containing TĪ²4 for direct instillation into affected eye(s), five times a day for 4 weeks.
Name:
Placebo
Type:
DRUG
Description:
It is composed of the same excipients as RGN-259 but does not contain TĪ²4
Primary Outcomes
Measure:
Percentage of Subjects Achieving Complete Healing at Day 29.
TimeFrame:
29 days after first dosing
Description:
Percentage of subjects achieving complete healing of the persistent epithelial defect as determined by corneal fluorescein staining at day 29 after first dosing.
Trial Information
NCT ID
NCT02600429
Status
Terminated
Study Type
INTERVENTIONAL
Phases
PHASE3
Sponsor
ReGenTree, LLC
Last Updated
December 15, 2025