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

Eligibility Criteria

• 1. Male or female aged ≥ 18 years.
• 2. Symptoms of neuropathic corneal pain for at least 3 months, such as burning, stinging, light sensitivity, discomfort, or pain.
• 3. Positive IVCM findings evaluated by an experienced ophthalmologist (Pedram Hamrah, M.D.): decreased nerve density AND evidence of microneuromas.
• 4. Females of childbearing potential must have a negative pregnancy test.
• 5. Best corrected distance visual acuity (BCDVA), using corrective lenses, if necessary, in the study eye of at least +1.0 Log MAR (Snellen \<20/200).
• 6. Satisfying all Informed Consent requirements.
• 7. Ability and willingness to comply with study procedures.
• 1. Evidence of any active ocular infection.
• 2. Evidence of any intraocular inflammation.
• 3. Evidence of any persistent epithelial defect/ulcer.
• 4. Evidence of any corneal scar/corneal edema.
• 5. Presence of any other ocular conditions that require topical medications during the treatment phase.
• 6. History of severe systemic allergy or severe ocular allergy.
• 7. Inability to suspend topical medications 8 days prior to the starting date.
• 8. Inability to continue oral medications for NCP without changes during the study duration.
• 9. No changes or less than 50% improvement in VAS score after topical 0.5% proparacaine hydrochloride (Alcaine, Alcon, Fort Worth, TX).
• 10. History of any ocular surgery within three months before study Visit 1(day 0).
• 11. Ocular surgery expected during the 16 weeks of the trial.
• 12. Use of refractive/therapeutic contact lenses during the study period.
• 13. Female subjects who are pregnant/have a positive pregnancy test result or are breastfeeding or intend to become pregnant during the study treatment period.
• 14. Drug addiction/alcohol abuse within the last year.
• 15. Participation in another clinical trial concurrently.