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

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).

Study Overview

• Status: Terminated
• Conditions: Neuropathic Pain
• Intervention / Treatment: Drug: Placebo; Drug: OK-101 0.05%; Drug: OK-101 0.1%

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.

• Study Type: Interventional
• Enrollment (Actual): 18
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02111
      • Tufts Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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	Drug: OK-101 0.05%; 0.05% Ophthalmic Solution
Experimental: 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.	Drug: OK-101 0.1%; 0.1% Ophthalmic Solution
Placebo Comparator: 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.	Drug: Placebo; Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assess ocular pain using 0-10 visual analog scale (VAS)	Visual analog scale questionaire will be used to evaluate the pain on 0-10 scale where 0 is no pain and 10 is worst pain imaginable.	16 Weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Ocular Pain Assessment Survey (OPAS) scores	Twenty-seven item questionnaires specifically designed to assess symptoms and quality of life in ocular pain.	16 Weeks
Ocular Surface Disease Index (OSDI©) scores	Twelve-item questionnaire to assess symptoms of ocular irritation consistent with dry eye and their impact on vision-related functioning.	16 Weeks
QoL Improvement assesed by OPAS score	Twenty-seven item questionnaires specifically designed to assess symptoms and quality of life in ocular pain	16 Weeks
Drop comfort Scores	Drop Comfort will be assesed using Scale 0-10, with a value of 0 being most comfortable and 10 being least comfortable.	16 Weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Asses corneal sensitivity thresholds obtained with the Cochet Bonnet esthesiometer on 0-6 scale (in cm)	Corneal Sensitivity will be measured using a Cochet Bonnet aesthesiometer before the instillation of any dilating or anesthetic eye drops. Corneal sensitivity will be assessed in the qualifying NEI zones of each eye. This instrument is constituted by a retractable 6 cm length filament of 0.12 mm in diameter, and it is considered the gold standard for corneal sensation assessment. We will gently press the monofilament against the cornea, and we will shorten it in steps of 1.0 cm if a negative response is obtained. If a positive response is obtained, we will advance the monofilament by 0.5cm, and we will consider the corneal sensitivity as the longest filament length necessary to obtain a positive response.	16 Weeks
Asses corneal nerve regeneration by measuring change in total length of corneal nerve regeneration	Change in total length of all nerves within an image (in mm/mm2) will be evaulated via In-Vivo Confocal Microscopy (IVCM) imaging	16 Weeks
Assess change in numbers of microneuromas	Presence of microneuromas will be graded from In-Vivo Confocal Microscopy (IVCM) imaging	16 Weeks
Asses change in dendritiform cells density by In-Vivo Confocal Microscopy (IVCM) imaging	Change in dendritiform cells density (in cells/mm^2) of Corneal Immune Dendritiform Cells will be assesed via Via In-Vivo Confocal Microscopy (IVCM) imaging	16 Weeks

Collaborators and Investigators

• Sponsor: Okyo Pharma Ltd
• Collaborators: Tufts Medical Center
• Investigators: Principal Investigator: Pedram Hamrah, MD, Tufts Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): October 15, 2024
• Primary Completion (Actual): April 30, 2025
• Study Completion (Actual): July 1, 2025

Study Registration Dates

• First Submitted: October 4, 2024
• First Submitted That Met QC Criteria: October 9, 2024
• First Posted (Actual): October 15, 2024

Study Record Updates

• Last Update Posted (Estimated): August 15, 2025
• Last Update Submitted That Met QC Criteria: August 12, 2025
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Nervous System Diseases; Neuromuscular Diseases; Peripheral Nervous System Diseases; Neuralgia
• Other Study ID Numbers: OK-101-NCP-001-23

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No