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

Neurotrophic Keratopathy Clinical Trial

Official title:
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

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Neurotrophic Keratopathy

Clinical Trial Details

NCT number	NCT02600429
Study type	Interventional
Source	ReGenTree, LLC
Contact
Status	Terminated
Phase	Phase 3
Start date	September 17, 2015
Completion date	March 9, 2020

View Details

See also
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Completed	`NCT04957758` - Phase 2 Clinical Trial to Evaluate OC-01 Nasal Spray in Subjects With Neurotrophic Keratopathy	Phase 2
Terminated	`NCT03084861` - A Clinical Trial to Asses Efficacy and Safety of Cord Blood Eye Drops in Neurotrophic Keratopathy	Phase 1/Phase 2
Active, not recruiting	`NCT06411145` - Open-label Trial to Evaluate Efficacy and Safety of rhNGF on Corneal Thickness Via AS-OCT in Neurotrophic Keratitis	Phase 4
Recruiting	`NCT05555589` - Assessment of the Safety and Efficacy of 0.1% RGN-259 Ophthalmic Solution for the Treatment of NK: SEER-2	Phase 3
Not yet recruiting	`NCT06331910` - Efficacy and Safety of Topical Insulin for Neurotrophic Corneal Ulcers	Phase 4