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

NCT06637527 | Terminated Phase 2 FDA Drug

• 1 other identifier: OK-101-NCP-001-23
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

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).

Conditions

Neuropathic Pain

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Ocular Pain Assessment Survey (OPAS) scores

  16 Weeks

• Ocular Surface Disease Index (OSDI©) scores

  16 Weeks

• QoL Improvement assesed by OPAS score

  16 Weeks

• Drop comfort Scores

  16 Weeks

Other Outcomes (4)

• Asses corneal sensitivity thresholds obtained with the Cochet Bonnet esthesiometer on 0-6 scale (in cm)

  16 Weeks

• Asses corneal nerve regeneration by measuring change in total length of corneal nerve regeneration

  16 Weeks

• Assess change in numbers of microneuromas

  16 Weeks

Study Arms (3)

Arm A

EXPERIMENTAL

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%

Arm B

EXPERIMENTAL

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%

Arm C

PLACEBO COMPARATOR

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

Interventions

OK-101 0.05% DRUG

0.05% Ophthalmic Solution

Arm A

OK-101 0.1% DRUG

0.1% Ophthalmic Solution

Arm B

Placebo DRUG

Placebo

Arm C

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female aged ≥ 18 years.
• Symptoms of neuropathic corneal pain for at least 3 months, such as burning, stinging, light sensitivity, discomfort, or pain.
• Positive IVCM findings evaluated by an experienced ophthalmologist (Pedram Hamrah, M.D.): decreased nerve density AND evidence of microneuromas.
• Females of childbearing potential must have a negative pregnancy test.
• 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).
• Satisfying all Informed Consent requirements.
• Ability and willingness to comply with study procedures.

You may not qualify if:

• Evidence of any active ocular infection.
• Evidence of any intraocular inflammation.
• Evidence of any persistent epithelial defect/ulcer.
• Evidence of any corneal scar/corneal edema.
• Presence of any other ocular conditions that require topical medications during the treatment phase.
• History of severe systemic allergy or severe ocular allergy.
• Inability to suspend topical medications 8 days prior to the starting date.
• Inability to continue oral medications for NCP without changes during the study duration.
• No changes or less than 50% improvement in VAS score after topical 0.5% proparacaine hydrochloride (Alcaine, Alcon, Fort Worth, TX).
• History of any ocular surgery within three months before study Visit 1(day 0).
• Ocular surgery expected during the 16 weeks of the trial.
• Use of refractive/therapeutic contact lenses during the study period.
• Female subjects who are pregnant/have a positive pregnancy test result or are breastfeeding or intend to become pregnant during the study treatment period.
• Drug addiction/alcohol abuse within the last year.
• Participation in another clinical trial concurrently.

Sponsors & Collaborators

• Okyo Pharma Ltd: lead
• Tufts Medical Center: collaborator

Study Sites (1)

Tufts Medical Center

Boston, Massachusetts, 02111, United States

Location

MeSH Terms

Conditions

Neuralgia

Condition Hierarchy (Ancestors)

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Pedram Hamrah, MD

  Tufts Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: This is a randomized, double-masked, placebo-controlled trial to investigate the efficacy of OK101 study drug in treating the symptoms of NCP at baseline (Visit 1) through the end of study (16 weeks) in NCP subjects.
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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).

Study Record Dates

• First Submitted: October 4, 2024
• First Posted: October 15, 2024
• Study Start: October 15, 2024
• Primary Completion: April 30, 2025
• Study Completion: July 1, 2025
• Last Updated: August 15, 2025

Record last verified: 2024-10

Locations

US (1)