Clinical trial NCT06637527: The Study Assessing the Safety and Efficacy of OK-101 Treatment in Subjects With Neuropathic Corneal Pain
Official title: A Phase 2a, Randomized, Double-Masked, Placebo-Controlled Study Assessing the Safety and Efficacy of OK-101 Treatment in Subjects With Neuropathic Corneal Pain
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Neuropathic Pain
Lead sponsor: Okyo Pharma Ltd
Sponsor class: INDUSTRY
Collaborators: name: Tufts Medical Center
First posted: 2024-10-15
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Intervention model description: Approximately 48 subjects will be randomized in a 1:1:1 ratio to receive treatment with 0.05% OK-101 (Arm A) or 0.1% OK-101 (Arm B) or placebo (Arm C).
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Assess ocular pain using 0-10 visual analog scale (VAS)
timeFrame: 16 Weeks
Secondary outcomes:
measure: Ocular Pain Assessment Survey (OPAS) scores
timeFrame: 16 Weeks
measure: Ocular Surface Disease Index (OSDI©) scores
timeFrame: 16 Weeks
measure: QoL Improvement assesed by OPAS score
timeFrame: 16 Weeks
measure: Drop comfort Scores
timeFrame: 16 Weeks
Other outcomes:
measure: Asses corneal sensitivity thresholds obtained with the Cochet Bonnet esthesiometer on 0-6 scale (in cm)
timeFrame: 16 Weeks
measure: Asses corneal nerve regeneration by measuring change in total length of corneal nerve regeneration
timeFrame: 16 Weeks
measure: Assess change in numbers of microneuromas
timeFrame: 16 Weeks
measure: Asses change in dendritiform cells density by In-Vivo Confocal Microscopy (IVCM) imaging
timeFrame: 16 Weeks
Locations:
city: Boston
country: United States
facility: Tufts Medical Center
state: Massachusetts
Study officials:
affiliation: Tufts Medical Center
name: Pedram Hamrah, MD
role: PRINCIPAL_INVESTIGATOR
References: