NCT06637527

The Study Assessing the Safety and Efficacy of OK-101 Treatment in Subjects With Neuropathic Corneal Pain

A Phase 2a, Randomized, Double-Masked, Placebo-Controlled Study Assessing the Safety and Efficacy of OK-101 Treatment in Subjects With Neuropathic Corneal Pain

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 18 (actual)
• Sponsor: Okyo Pharma Ltd · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The primary objective of this study, in subjects with Neuropathic Corneal Pain, is to evaluate the efficacy and safety of OK-101 0.05% and 0.1% as compared to placebo instilled 4 times/day in subjects with neuropathic corneal pain, as assessed by visual analogue scale (VAS).

Detailed description

Detailed Description: Neuropathic corneal pain (NCP) is a complex disease affecting the somatosensory nervous system characterized by different underlying etiologies and pathogenesis. OK-101 is a lipid conjugated chemerin peptide antagonist of the ChemR23 G-protein coupled receptor which is typically found on immune cells of the eye responsible for the inflammatory response. OK-101 has been shown to produce anti-inflammatory and pain-reducing activities in mouse models of dry eye disease and neuropathic corneal pain; and is designed to combat washout through the inclusion of the lipid 'anchor' contained in the candidate drug molecule to enhance the residence time of OK-101 within the ocular environment. Our preclinical studies have shown that treatment with OK-101 abolishes corneal pain in a murine model of NCP.

Conditions

• Neuropathic Pain

Interventions

Type	Name	Description
DRUG	OK-101 0.05%	0.05% Ophthalmic Solution
DRUG	OK-101 0.1%	0.1% Ophthalmic Solution
DRUG	Placebo	Placebo

Timeline

• Start date: 2024-10-15
• Primary completion: 2025-04-30
• Completion: 2025-07-01
• First posted: 2024-10-15
• Last updated: 2025-08-15

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study