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Urcosimod is a preservative-free product; supplied in unit dose ampoules; administered QID for 12-weeks

Phase 3

Neuropathic Corneal Pain | Small molecule | Neurology |OKYO Pharma Limited|Last Updated: Sep 24, 2026

Success Probability

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment111

FDA Designations

FAST_TRACKBREAKTHROUGH_THERAPY

Clinical trial landscape

Urcosimod is a preservative-free product; supplied in unit dose ampoules; administered QID for 12-weeks · 1 trial · 1 indication

Phase 3 1
NCT07838506Phase 3, Multi-Center, Randomized, Double-Masked, Placebo-Controlled Study Assessing the Safety and Efficacy of Urcosimod Ophthalmic Solution in Participants With Neuropathic Corneal Pain (NCP).Neuropathic Corneal Pain
NOT YET_RECRUITING111 Analytics
PHASE3NOT YET_RECRUITING
Phase 3, Multi-Center, Randomized, Double-Masked, Placebo-Controlled Study Assessing the Safety and Efficacy of Urcosimod Ophthalmic Solution in Participants With Neuropathic Corneal Pain (NCP).
Neuropathic Corneal Pain
NCT07838506111
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Study Endpoints

Primary Endpoints

The change from baseline at Week 12 in ocular pain assessed by VAS score.
From baseline (time of randomization) compared to Week 12.

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.

Secondary Endpoints

Change from baseline at Week 12 in Quality-of-Life scores (7 QoL questions from OPAS survey).
Baseline visit compared to Week 12.
Change from baseline at Weeks 4, 8, and 16 in ocular pain assessed by VAS score.
Baseline visit compared to Weeks 4, 8 and 16.
Change from baseline at Week 2 in ocular pain assessed by VAS score in the participant diary.
Baseline visit compared to Week 2 of treatment period.
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Study Design & Arms

AllocationRANDOMIZED
MaskingTRIPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Urcosimod Ophthalmic SolutionEXPERIMENTAL• Urcosimod 0.05% - one drop in affected eye(s), four times a day
Vehicle ophthalmic solutionPLACEBO_COMPARATORVehicle - one drop in affected eye(s), four times a day.

Interventions

NameTypeDescription
Urcosimod ophthalmic solution is a preservative-free topical ophthalmic product; supplied in unit dose ampoules; administered QID for 12-weeks.DRUGVehicle solution of the study drug (without active ingredient); preservative-free topical ophthalmic solution supplied in unit-dose ampoules; administered QID for 12-weeks.
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: 1. Aged 18 years of age or older. 2. Able and willing to provide written informed consent prior to any study-related procedures. 3. Presence of symptoms of neuropathic corneal pain for at least 3 months defined as the presence of ocular pain associated or not with ocular symptom...

Countries:United States
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Recent Changes (Last 90 Days)

LOWSep 24, 2026NCT07838506NEW_TRIAL: changed
LOWSep 24, 2026NCT07838506NEW_TRIAL: changed

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