Evaluating OK-101 for treating 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

This study is testing a new treatment called OK-101 to see if it can help people with nerve pain in their eyes feel better compared to a placebo.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 48 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Okyo Pharma Ltd (Industry-sponsored)
• Locations: 1 site (Boston, Massachusetts)
• Trial ID: NCT06637527 on ClinicalTrials.gov

What this trial studies

This study aims to assess the safety and efficacy of OK-101, a novel treatment for neuropathic corneal pain, by comparing two concentrations (0.05% and 0.1%) against a placebo. Participants will receive the treatment four times a day, and the effectiveness will be measured using a visual analogue scale (VAS). The study focuses on individuals who have experienced symptoms of neuropathic corneal pain for at least three months and have specific diagnostic findings. The goal is to determine if OK-101 can alleviate pain and improve quality of life for affected patients.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with neuropathic corneal pain symptoms lasting at least three months and specific diagnostic findings.

Not a fit: Patients with active ocular infections, intraocular inflammation, or other significant ocular conditions may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly reduce pain and improve the quality of life for patients suffering from neuropathic corneal pain.

How similar studies have performed: While this approach is novel, preclinical studies have shown promising results in mouse models for similar conditions.

Eligibility criteria

Inclusion 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.

Exclusion Criteria:

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.

Where this trial is running

Boston, Massachusetts

• Tufts Medical Center — Boston, Massachusetts, United States (Recruiting)

Study contacts

• Principal investigator: Pedram Hamrah, MD — Tufts Medical Center
• Study coordinator: Raj Patil, PhD

Conditions Neuropathic Pain