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

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).

Timeline

Start

2024-10-15

Primary completion

2025-04-30

Completion

2025-07-01

Outcome

Outcome not reported

Stopped: “Study ended early to expedite development and enable earlier FDA discussions. Prior Phase 2 data (240 patients) showed favorable safety and placebo-like tolerability. Closure was not due to safety concerns.”

Drugs

Indications