NCT02600429

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

Phase 3, Multi-Center, Randomized, Double Masked, Placebo Controlled Clinical Study to Assess the Safety and Efficacy of RGN-259 Ophthalmic Solution for the Treatment of Neurotrophic Keratopathy: SEER-1

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 18 (actual)
• Sponsor: ReGenTree, LLC · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Neurotrophic Keratopathy

Interventions

Type	Name	Description
DRUG	RGN-259	A preservative-free, sterile eye drop solution containing Tβ4 for direct instillation into affected eye(s), five times a day for 4 weeks.
DRUG	Placebo	It is composed of the same excipients as RGN-259 but does not contain Tβ4

Timeline

• Start date: 2015-09-17
• Primary completion: 2019-11-20
• Completion: 2020-03-09
• First posted: 2015-11-09
• Last updated: 2023-08-30
• Results posted: 2023-08-14

Locations

11 sites across 1 country: United States