OK-101 for Neuropathic Corneal Pain

Overseen By Nancy Gee, MPH

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Okyo Pharma Ltd

Must not be taking: Topical medications

Disqualifiers: Ocular infection, Intraocular inflammation, Corneal scar, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

48 Participants Needed

Trial Summary

What is the purpose of this trial?

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).

Will I have to stop taking my current medications?

You will need to stop using any topical eye medications 8 days before the trial starts. However, you can continue taking your oral medications for neuropathic corneal pain as long as there are no changes during the study.

How is the drug OK-101 different from other treatments for neuropathic corneal pain?

OK-101 is unique because it is specifically being studied for neuropathic corneal pain, a condition with limited treatment options, and it may offer a novel approach compared to existing therapies that often focus on dry eye disease or other types of neuropathic pain. ^{1 2 3 4 5}

Research Team

Pedram Hamrah, MD

Principal Investigator

Tufts Medical Center

Eligibility Criteria

This trial is for individuals experiencing neuropathic corneal pain, which is a type of nerve pain in the eye. Participants should be able to apply eye drops four times a day. The specific inclusion and exclusion criteria are not provided, but typically these would detail necessary conditions or characteristics participants must have or lack.

Inclusion Criteria

I am 18 years old or older.

Satisfying all Informed Consent requirements

I have had symptoms like burning or pain in my eye for at least 3 months.

Exclusion Criteria

Evidence of any corneal scar/corneal edema

I have signs of inflammation inside my eye.

I have not had eye surgery in the last 3 months.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive OK-101 or placebo instilled in affected eye(s) four times daily for 12 weeks

12 weeks

Regular visits for monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• OK-101

Trial Overview The study tests two concentrations of OK-101 (0.05% and 0.1%) against a placebo to see if they can reduce eye pain when used as eye drops four times daily. Effectiveness will be measured using a visual analogue scale (VAS), which helps patients rate their pain level.

Participant Groups

Group I: Arm B Experimental Treatment 1 Intervention

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 II: Arm A Experimental Treatment 1 Intervention

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 III: Arm C Placebo Group 1 Intervention

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.

Who Is Running the Clinical Trial?

Okyo Pharma Ltd

Lead Sponsor

Trials

2

Recruited

290+

Tufts Medical Center

Collaborator

Trials

264

Recruited

264,000+

Findings from Research

Neuropathic corneal pain (NCP) is a challenging condition to manage due to its ill-defined nature, and this review provides guidelines for diagnosis and treatment based on a systematic literature search from 1966 to 2017, including evidence from randomized controlled trials.

First-line treatments for NCP include topical neuroregenerative and anti-inflammatory agents, as well as systemic medications like tricyclic antidepressants and anticonvulsants, while complementary therapies such as acupuncture and omega-3 supplementation may offer additional benefits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Neuropathic Corneal Pain: Approaches for Management. Dieckmann, G., Goyal, S., Hamrah, P.[2022]

Corneal neuropathic pain can occur in patients with dry eye disease even when there are no visible signs, making diagnosis and treatment challenging.

Understanding corneal neuropathic pain as a distinct condition is crucial for developing better treatment options for patients suffering from this debilitating issue.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Corneal pain without stain: is it real? Rosenthal, P., Baran, I., Jacobs, DS.[2022]

In a rat model of dry eye disease (DED), mirogabalin significantly reduced hyperalgesia and chronic ocular pain, indicating its potential effectiveness for treating similar symptoms in humans.

Mirogabalin administration led to a notable decrease in pain-related behaviors and reduced markers of pain in the brain, suggesting it could be a promising treatment option for patients suffering from DED-related ocular pain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of Mirogabalin on Hyperalgesia and Chronic Ocular Pain in Tear-Deficient Dry-Eye Rats. Kikuchi, K., Tagawa, Y., Murata, M., et al.[2023]

In a case series of three patients with severe neuropathic dry eye-like pain, two patients experienced significant pain relief within 48 hours after treatment for hidden Meibomian gland dysfunction, highlighting the importance of identifying and treating underlying ocular surface issues.

The findings suggest that addressing peripheral causes of pain, such as obstructive Meibomian gland dysfunction, can effectively reverse symptoms of neuropathic pain, potentially reducing the need for systemic treatments that carry risks of serious side effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Successful reversal of neuropathic eye pain by treatment of occult ocular surface disease: Case series and implications. Maskin, SL.[2022]

Topical corticosteroids and blood-derived tear preparations have been found to be effective in treating corneal neuropathic pain, which often does not respond to standard dry eye treatments.

Emerging therapies like topical lacosamide and low-dose naltrexone show promise as additional options for managing this type of pain, highlighting the need for diverse treatment strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Topical Therapeutic Options in Corneal Neuropathic Pain. Nortey, J., Smith, D., Seitzman, GD., et al.[2022]

References

1. United States pubmed.ncbi.nlm.nih.gov

Neuropathic Corneal Pain: Approaches for Management. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Corneal pain without stain: is it real? [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Effects of Mirogabalin on Hyperalgesia and Chronic Ocular Pain in Tear-Deficient Dry-Eye Rats. [2023]

4. United States pubmed.ncbi.nlm.nih.gov

Successful reversal of neuropathic eye pain by treatment of occult ocular surface disease: Case series and implications. [2022]

5. Switzerland pubmed.ncbi.nlm.nih.gov

Topical Therapeutic Options in Corneal Neuropathic Pain. [2022]