48 Participants Needed

OK-101 for Neuropathic Corneal Pain

RP
NG
Overseen ByNancy Gee, MPH
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

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.12345

Who Is on the Research Team?

Ophthalmologist Boston | Pedram Hamrah ...

Pedram Hamrah, MD

Principal Investigator

Tufts Medical Center

Are You a Good Fit for This Trial?

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

Satisfying all Informed Consent requirements
I have had symptoms like burning or pain in my eye for at least 3 months.
Ability and willingness to comply with study procedures
See 3 more

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.
See 12 more

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.
How Is the Trial Designed?
3Treatment groups
Experimental Treatment
Placebo Group
Group I: Arm BExperimental Treatment1 Intervention
Group II: Arm AExperimental Treatment1 Intervention
Group III: Arm CPlacebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Okyo Pharma Ltd

Lead Sponsor

Trials
2
Recruited
290+

Tufts Medical Center

Collaborator

Trials
264
Recruited
264,000+

Published Research Related to This Trial

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

Citations

Neuropathic Corneal Pain: Approaches for Management. [2022]
Corneal pain without stain: is it real? [2022]
Effects of Mirogabalin on Hyperalgesia and Chronic Ocular Pain in Tear-Deficient Dry-Eye Rats. [2023]
Successful reversal of neuropathic eye pain by treatment of occult ocular surface disease: Case series and implications. [2022]
Topical Therapeutic Options in Corneal Neuropathic Pain. [2022]
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