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OK-101 for Neuropathic Corneal Pain

Phase 2

Recruiting

Led By Pedram Hamrah, MD

Research Sponsored by Okyo Pharma Ltd

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Symptoms of neuropathic corneal pain for at least 3 months, such as burning, stinging, light sensitivity, discomfort, or pain

Females of childbearing potential must have a negative pregnancy test

Must not have

Evidence of any intraocular inflammation

Use of refractive/therapeutic contact lenses during the study period

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 16 weeks

Summary

"This trial aims to see if OK-101 at two different strengths is better than a placebo in relieving pain in people with Neuropathic Corneal Pain. The pain levels will be measured

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

While the side effects are not listed here, common side effects for ocular medications may include temporary discomfort, redness, blurred vision, tearing or dryness in the eyes after application.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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

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I am of childbearing age and my pregnancy test is negative.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have signs of inflammation inside my eye.

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I will be using corrective or therapeutic contact lenses during the study.

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I cannot stop using my skin medications for 8 days before starting.

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I can't take my usual oral medications without changes for the study period.

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I am expected to have eye surgery within the next 16 weeks.

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I am not pregnant, breastfeeding, nor plan to become pregnant during the study.

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I need eye drops for another eye condition during the treatment.

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I currently have an eye infection.

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My eye pain did not improve much after using a specific eye drop.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 16 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~16 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 16 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Assess ocular pain using 0-10 visual analog scale (VAS)

Secondary study objectives

Drop comfort Scores

Ocular Pain Assessment Survey (OPAS) scores

Ocular Surface Disease Index (OSDI©) scores

+1 more

Other study objectives

Asses change in dendritiform cells density by In-Vivo Confocal Microscopy (IVCM) imaging

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

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

+1 more

Trial Design

3Treatment groups

Experimental Treatment

Placebo Group

Group I: Arm BExperimental Treatment1 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 AExperimental Treatment1 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 CPlacebo Group1 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.

0 / 11Eligibility criteria met