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
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.
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. ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT04604834 -
Autologous Platelet-rich Plasma (APRP) in the Treatment of Neurotrophic Keratopathy
|
N/A | |
| Completed |
NCT04293549 -
An 8-week Follow-up to Evaluate the Renewal of Corneal Nerves Structure and Function in Patients With Neurotrophic Keratopathy Treated With Recombinant Human Nerve Growth Factor (rhNGF) Eyedrops
|
||
| 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 | |
| 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 |