[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100657517":3},{"organization":4,"outcomesModule":7,"designInfo":27,"detailedDescription":39,"studyPopulation":26,"armGroups":40,"interventions":53,"overallOfficials":64,"centralContacts":26,"locations":68,"responsibleParty":88,"collaborators":26,"id":90,"slug":91,"hasResults":92,"nctId":93,"briefTitle":94,"officialTitle":95,"acronym":96,"eligibilityCriteria":97,"healthyVolunteers":92,"sex":98,"minAge":99,"maxAge":26,"enrollmentInfo":100,"targetDuration":26,"studyType":103,"phases":104,"briefSummary":106,"conditions":107,"keywords":109,"overallStatus":111,"whyStopped":26,"lastUpdateSubmitDate":112,"lastUpdatePostDateStruct":113,"startDateStruct":116,"completionDateStruct":118,"leadSponsor":120,"locationsCount":121},{"fullName":5,"class":6},"Okyo Pharma Ltd","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":26},[9],{"measure":10,"description":11,"timeFrame":12},"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\u002Fday in participants who have a documented ocular history of symptoms of neuropathic corneal pain.","From baseline (time of randomization) compared to Week 12.",[14,18,22],{"measure":15,"description":16,"timeFrame":17},"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.","Baseline visit compared to Week 12.",{"measure":19,"description":20,"timeFrame":21},"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.","Baseline visit compared to Weeks 4, 8 and 16.",{"measure":23,"description":24,"timeFrame":25},"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.","Baseline visit compared to Week 2 of treatment period.",null,{"allocation":28,"interventionModel":29,"interventionModelDescription":30,"primaryPurpose":31,"observationalModel":26,"timePerspective":26,"maskingInfo":32},"RANDOMIZED","PARALLEL","Phase 3 study is designed to evaluate the safety and efficacy of urcosimod 0.05% eye drops compared to vehicle as the placebo control when dosed QID for 12 weeks in participants with neuropathic corneal pain.\n\nStudy includes 6 planned site visits (Visit 1\u002FScreening \\[Day -7 to Day 1 prior to Baseline\\], Visit 2\u002FBaseline\u002FDay 1, Visit 3\u002FWeek 4, Visit 4\u002FWeek 8, Visit 5\u002FWeek 12\u002FEnd of Treatment Period, Visit 6\u002FWeek 16\u002FEnd of Study Visit. If eligibility criteria are met at Visit 2\u002FBaseline, participants will be randomized, Investigational Medicinal Product (IMP) dispensed and self-administration will start at Visit 2\u002FDay 1 and continue for 12 weeks (through Visit 5\u002FEnd of Treatment visit). After completion of treatment, participants will enter a 4-week follow-up period for post-treatment evaluation and safety follow-up with 1 clinic visit at Week 16\u002FEnd of Study (Visit 6)","TREATMENT",{"masking":33,"maskingDescription":34,"whoMasked":35},"TRIPLE","The randomization code will be computer-generated by the Sponsor designee. Randomization team members will not be involved in the day-to-day conduct of the study and work independently of the study team. Study personnel, study participants, the Sponsor, and project teams at the clinical research organization(s) (CRO) involved in the study will be masked to IMP assignments.",[36,37,38],"PARTICIPANT","CARE_PROVIDER","INVESTIGATOR","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.",[41,47],{"label":42,"type":43,"description":44,"interventionNames":45},"Urcosimod Ophthalmic Solution","EXPERIMENTAL","• Urcosimod 0.05% - one drop in affected eye(s), four times a day",[46],"Drug: Urcosimod ophthalmic solution is a preservative-free topical ophthalmic product; supplied in unit dose ampoules; administered QID for 12-weeks.",{"label":48,"type":49,"description":50,"interventionNames":51},"Vehicle ophthalmic solution","PLACEBO_COMPARATOR","Vehicle - one drop in affected eye(s), four times a day.",[52],"Other: Vehicle Ophthalmic Solution",[54,59],{"type":55,"name":56,"description":57,"armGroupLabels":58,"otherNames":26},"DRUG","Urcosimod ophthalmic solution is a preservative-free topical ophthalmic product; supplied in unit dose ampoules; administered QID for 12-weeks.","Topical ophthalmic solution, applied as 1 drop QID in affected eye(s)\\* for the 12-week Treatment Period",[42],{"type":60,"name":61,"description":62,"armGroupLabels":63,"otherNames":26},"OTHER","Vehicle Ophthalmic Solution","Vehicle solution of the study drug (without active ingredient); preservative-free topical ophthalmic solution supplied in unit-dose ampoules; administered QID for 12-weeks.",[48],[65],{"name":66,"affiliation":5,"role":67},"Flavio Mantelli, MD, PhD","STUDY_DIRECTOR",[69],{"facility":70,"status":26,"city":71,"state":72,"zip":73,"country":74,"countryCode":75,"cosmosGeoPoint":76,"geoPoint":81,"contacts":82},"Toyos Eye Clinic","Nashville","Tennessee","37215","United States","US",{"type":77,"coordinates":78},"Point",[79,80],-86.78444,36.16589,{"lat":80,"lon":79},[83],{"name":84,"role":85,"phone":86,"phoneExt":26,"email":87},"Study Coordinator","CONTACT","615-327-4015","hcheney@toyosclinic.com",{"type":89,"investigatorFullName":26,"investigatorTitle":26,"investigatorAffiliation":26,"oldNameTitle":26,"oldOrganization":26},"SPONSOR","100657517","phase-3-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-100657517",false,"NCT07838506","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).","A Phase 3, Multi-Center, Randomized, Double-Masked, Placebo-Controlled Study Assessing the Safety and Efficacy of Urcosimod (Formerly Called OK-101) Ophthalmic Solution in Participants With Neuropathic Corneal Pain (NCP).","NEPTUNE","Inclusion Criteria:\n\n1. Aged 18 years of age or older.\n2. Able and willing to provide written informed consent prior to any study-related procedures.\n3. 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.\n4. In at least one eye:\n\n   1. Ocular pain score of 5 or more on 0-10 Visual Analogue Scale (VAS) AND in the same eye\n   2. In Vivo Confocal Microscopy (IVCM) changes of the subbasal corneal nerve plexus assessed by an Investigator who has received study-specific training.\n5. Female participants must be one of the following: a) postmenopausal (defined as no menses for 1 year), b) surgically sterilized, c) practicing abstinence as a lifestyle choice (not as a form of contraception), or d) consistently and correctly using protocol-specified birth control for the duration of the study (e.g., a hormonal contraceptive, intrauterine device, diaphragm with spermicide, or condom with spermicide; see Appendix 3).\n6. Female participants who are neither postmenopausal nor surgically sterile require a negative urine pregnancy test at the Screening and Day 1\u002FBaseline visits.\n7. Best corrected distance visual acuity (BCDVA), in the study eye of at least Snellen \\>20\u002F200.\n8. Participants that require topical ophthalmic medications during the study may be included if the medications are not topical ophthalmic blood-derived products, amniotic-membrane derived medications, cenegermin (Oxervate®), topical ophthalmic anti-allergic, anti-inflammatory, immunosuppressive and immunomodulators such as lifitegrast, and the dose has been stable for at least 3 months prior to Screening and is expected to remain stable throughout the study period.\n9. Ability and willingness to comply with study procedures.\n\nExclusion Criteria:\n\nParticipants who meet any of the following criteria at Visit 1\u002FScreening or Visit 2\u002FBaseline will be excluded from the study.\n\n1. Evidence of any active ocular infection (bacterial, viral, fungal or protozoal) in either eye.\n2. Evidence of any intraocular inflammation defined as anterior chamber flare \\> 0 and\u002For cells \\>0 by Standardization of Uveitis Nomenclature (SUN) grading, in either eye.\n3. 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.\n4. Presence of eyelid abnormalities such as trichiasis and lagophthalmos that can be the primary cause of corneal epithelial damage and ocular pain.\n5. Evidence of any elevated corneal scars\u002Fcorneal edema.\n6. Any other concomitant medical condition that, in the judgment of the Principal Investigator (PI), might interfere with the conduct of the study, confound the interpretation of the study results, or endanger the participant's well-being.\n7. Use of topical ophthalmic calcineurin inhibitors such as Cyclosporin A, tacrolimus, pimecrolimus, or cenegermin (Oxervate®) in either eye in the 4 weeks prior to Visit 1\u002FScreening visit.\n8. History of severe systemic allergic condition or severe ocular allergy.\n9. Inability to suspend use of intranasal tear secretagogues such as varenicline or device for dry eye at Visit 1\u002FScreening and throughout the study period.\n10. Inability to suspend prohibited ocular topical medications at Visit 1\u002FScreening.\n11. Inability to suspend use of blood-derived ocular treatments (e.g., autologous serum tears, platelet-rich plasma, etc.) or amniotic membrane-derived products at Visit 1\u002FScreening visit.\n12. Inability to continue stable (for at least 3 months) oral medications for NCP without changes during the entire study period.\n13. No change or less than 50% improvement in ocular pain assessed by VAS score after topical anesthetic challenge.\n14. History of any ocular surgery within 3 months prior to Visit 1\u002FScreening.\n15. Any anticipated ocular surgery during the entire study period.\n16. Inability to suspend use of refractive\u002Ftherapeutic contact lenses (including scleral lenses), botulinum toxin or electro\u002Fmagnetic stimulation devices on the eye, face or scalp, during the entire study period.\n17. Prior use of periocular or ocular botulinum toxin (Botox) within 3 months of Visit 1\u002FScreening.\n18. Evidence of current drug or alcohol abuse or addiction.\n19. Participated in or used the investigational agent in another clinical study, within 30 days prior to Visit 1\u002FScreening.\n20. Known hypersensitivity to any of the components of the study drug, preservative-free artificial tears or procedural medications (e.g., fluorescein, anesthetic drops, etc.).\n21. Previous participation in a clinical study or extended access program with urcosimod eye drops.","ALL","18 Years",{"count":101,"type":102},111,"ESTIMATED","INTERVENTIONAL",[105],"PHASE3","This study is testing a new investigational study drug called Urcosimod Ophthalmic Solution for the treatment of Neuropathic Corneal Pain (NCP).",[108],"Neuropathic Corneal Pain",[110],"NEPTUNE, NCP, Ocular pain, Urcosimod","NOT_YET_RECRUITING","2026-09-24",{"date":114,"type":115},"2026-09-29","ACTUAL",{"date":117,"type":102},"2026-09",{"date":119,"type":102},"2027-10",{"name":5,"class":6},1]