A Phase 3 interventional study of Urcosimod ophthalmic solution is a preservative-free topical ophthalmic product; supplied in unit dose ampoules; administered QID for 12-weeks. and Vehicle Ophthalmic Solution in Neuropathic Corneal Pain, sponsored by Okyo Pharma Ltd. Not yet recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-29.
Sponsored by Okyo Pharma Ltd · Phase 3, Interventional, and Treatment
This study is testing a new investigational study drug called Urcosimod Ophthalmic Solution for the treatment of Neuropathic Corneal Pain (NCP).
This research study is to evaluate the safety of Urcosimod Ophthalmic Solution and its effect on the quality of life and vision in participants with Neuropathic Corneal Pain (NCP). The purpose of this research study will see if urcosimod can safely and effectively relieve the signs and symptoms of NCP, and whether it causes any side effects.
31 studies on the registry are indexed under Eye Pain; 7 are open to participants now.
This study's planned enrollment of 111 is above the median of 55 across 28 interventional studies indexed under Eye Pain.
Browse Eye Pain studies →Okyo Pharma Ltd is the lead sponsor of 3 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
In at least one eye:
Exclusion Criteria:
Participants who meet any of the following criteria at Visit 1/Screening or Visit 2/Baseline will be excluded from the study.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Postmenopausal
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
• Urcosimod 0.05% - one drop in affected eye(s), four times a day
Drug: Urcosimod ophthalmic solution is a preservative-free topical ophthalmic product; supplied in unit dose ampoules; administered QID for 12-weeks.
Vehicle - one drop in affected eye(s), four times a day.
Other: Vehicle Ophthalmic Solution
Topical ophthalmic solution, applied as 1 drop QID in affected eye(s)\* for the 12-week Treatment Period
Vehicle solution of the study drug (without active ingredient); preservative-free topical ophthalmic solution supplied in unit-dose ampoules; administered QID for 12-weeks.
The change from baseline at Week 12 in ocular pain assessed by Visual Analogue Scale (0-10) score. (Score of 10 is "worst possible pain".)
Evaluate the efficacy and safety of urcosimod 0.05% as compared to placebo instilled 4 times/day in participants who have a documented ocular history of symptoms of neuropathic corneal pain.
Time frame: From baseline (time of randomization) compared to Week 12.
Change from baseline at Week 12 in Quality-of-Life score.
Evaluate improvement in quality-of-life as measured by the Ocular Pain Assessment Survey.
Time frame: Baseline visit compared to Week 12.
Change from baseline at Weeks 4, 8, and 16 in ocular pain assessed by Visual Analogue Scale (0-10) score. (Score of 10 is "worst possible pain".)
Evaluate improvement in ocular pain assessed by Visual Analogue Scale score.
Time frame: Baseline visit compared to Weeks 4, 8 and 16.
Change from baseline at Week 2 in ocular pain assessed by Visual Analogue Scale (0-10) score in the participant diary. (Score of 10 is "worst possible pain".)
Evaluate improvement in ocular pain assessed by Visual Analogue Scale (0-10) score.
Time frame: Baseline visit compared to Week 2 of treatment period.
Plan to share: No
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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