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

NCT ID: NCT06637527

Last Updated: 2025-08-15

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 18 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-10-15
• Study Completion Date: 2025-07-01

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: FACTORIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Arm A

OK-101, 0.05% - one drop of study drug (0.05%) will be instilled in affected eye(s), four times daily (every 4 hours up to 16 hours, e.g., 9:00 am, 01:00 pm; 05:00 pm, 09:00pm) for 12 weeks

Group Type: EXPERIMENTAL

OK-101 0.05%

Intervention Type: DRUG

0.05% Ophthalmic Solution

Arm B

OK-101, 0.1% - one drop of study drug (0.1%) will be instilled in affected eye(s), four times daily (every 4 hours up to 16 hours, e.g., 9:00 am, 01:00 pm; 05:00 pm, 09:00pm) for 12 weeks.

Group Type: EXPERIMENTAL

OK-101 0.1%

Intervention Type: DRUG

0.1% Ophthalmic Solution

Arm C

Placebo - one drop of placebo will be instilled in affected eye(s), four times daily (every 4 hours up to 16 hours, e.g., 9:00 am, 01:00 pm; 05:00 pm, 09:00pm) for 12 weeks.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Placebo

Interventions

OK-101 0.05%

0.05% Ophthalmic Solution

Intervention Type: DRUG

OK-101 0.1%

0.1% Ophthalmic Solution

Intervention Type: DRUG

Placebo

Placebo

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Tufts Medical Center

OTHER

Sponsor Role: collaborator

Okyo Pharma Ltd

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Pedram Hamrah, MD

Role: PRINCIPAL_INVESTIGATOR

Tufts Medical Center

Locations

Tufts Medical Center

Boston, Massachusetts, United States

Countries

United States

Other Identifiers

OK-101-NCP-001-23

Identifier Type: -

Identifier Source: org_study_id