Health TrialsbyHealthPanel

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).

ConditionNeuropathic Corneal Pain
Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorOkyo Pharma Ltd

About this trial

This study is testing a new investigational study drug called Urcosimod Ophthalmic Solution for the treatment of Neuropathic Corneal Pain (NCP).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Aged 18 years of age or older.

Able and willing to provide written informed consent prior to any study-related procedures.

Presence of symptoms of neuropathic corneal pain for at least 3 months defined as the presence of ocular pain associated or not with ocular symptoms of burning, stinging, light sensitivity or discomfort.

Ocular pain score of 5 or more on 0-10 Visual Analogue Scale (VAS) AND in the same eye

Disqualifiers

Evidence of any active ocular infection (bacterial, viral, fungal or protozoal) in either eye.

Evidence of any intraocular inflammation defined as anterior chamber flare > 0 and/or cells >0 by Standardization of Uveitis Nomenclature (SUN) grading, in either eye.

Presence of any other ocular surface condition that may cause ocular pain including confluent punctuate staining, any corneal epithelial defect or ulcer, angle-closure glaucoma or uveitis, in either eye.

Presence of eyelid abnormalities such as trichiasis and lagophthalmos that can be the primary cause of corneal epithelial damage and ocular pain.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Urcosimod ophthalmic solution is a preservative-free topical ophthalmic product; supplied in unit dose ampoules; administered QID for 12-weeks.

    Drug

    Topical ophthalmic solution, applied as 1 drop QID in affected eye(s)\* for the 12-week Treatment Period

  • Vehicle Ophthalmic Solution

    Other intervention

    Vehicle solution of the study drug (without active ingredient); preservative-free topical ophthalmic solution supplied in unit-dose ampoules; administered QID for 12-weeks.

Treatment groups

111 Participants
are divided into 2 treatment groups
Group A: Urcosimod Ophthalmic SolutionExperimental treatment 1 intervention
Group B: Vehicle ophthalmic solutionPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

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.

Secondary outcomes

1

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.
2

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.
3

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.

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Okyo Pharma Ltd

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: