[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100658280":3},{"organization":4,"outcomesModule":7,"designInfo":26,"detailedDescription":32,"studyPopulation":25,"armGroups":33,"interventions":40,"overallOfficials":46,"centralContacts":51,"locations":60,"responsibleParty":81,"collaborators":83,"id":87,"slug":88,"hasResults":89,"nctId":90,"briefTitle":91,"officialTitle":91,"acronym":92,"eligibilityCriteria":93,"healthyVolunteers":89,"sex":94,"minAge":95,"maxAge":25,"enrollmentInfo":96,"targetDuration":25,"studyType":99,"phases":100,"briefSummary":102,"conditions":103,"keywords":106,"overallStatus":109,"whyStopped":25,"lastUpdateSubmitDate":110,"lastUpdatePostDateStruct":111,"startDateStruct":114,"completionDateStruct":116,"leadSponsor":118,"locationsCount":119},{"fullName":5,"class":6},"University of South Florida","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":25},[9],{"measure":10,"description":11,"timeFrame":12},"Change in Unanesthetized Schirmer Test Score at Week 8","Mean change from the pre-dose measurement at baseline (Day 1) to the measurement taken 3 minutes after dosing at Week 8. Range: 0-35 mm Interpretation: Higher scores indicate greater tear production and a better outcome.","Time frame: Baseline to Week 8",[14,18,22],{"measure":15,"description":16,"timeFrame":17},"Acute Change in Unanesthetized Schirmer Test Score on Day 1","Mean change from the pre-dose measurement to the measurement taken 3 minutes after the first dose. Range: 0-35 mm Interpretation: Higher scores indicate greater tear production and a better outcome.","Pre-dose to 3 minutes post-dose on Day 1",{"measure":19,"description":20,"timeFrame":21},"Change in Neuropathic Ocular Symptom Intensity","Change in pain, discomfort, or another identified neuropathic symptom measured using a 0-10 visual analog scale (VAS). Range: 0-10 Interpretation: Higher scores indicate greater pain or symptom severity and a worse outcome.","Baseline to Week 8",{"measure":23,"description":24,"timeFrame":21},"Change in Ocular Pain-Related Quality of Life","Change in quality of life measured using the Ocular Pain Assessment Survey (OPAS). Range: 0-10 Interpretation: Higher scores indicate greater ocular pain and symptom severity and a worse outcome.",null,{"allocation":27,"interventionModel":28,"interventionModelDescription":25,"primaryPurpose":29,"observationalModel":25,"timePerspective":25,"maskingInfo":30},"NA","SINGLE_GROUP","TREATMENT",{"masking":31,"maskingDescription":25,"whoMasked":25},"NONE","AURORA is a prospective, open-label, single-center, single-arm investigator-initiated study evaluating TRYPTYR (acoltremon ophthalmic solution 0.003%) in 28 adults with neuropathic corneal pain and concurrent tear deficiency. Eligible participants must have neuropathic ocular symptoms for at least 3 months, a driving symptom score of at least 4 on a 0-10 VAS (Visual Analog Scale), reduced corneal nerve density and microneuromas on IVCM (In Vivo Confocal Microscopy), at least 50% symptom improvement following topical proparacaine, and an unanesthetized Schirmer score of at least 2 mm but less than 10 mm.\n\nParticipants will administer acoltremon 0.003% in both eyes twice daily for 8 weeks. One qualifying eye per participant will be designated as the study eye for analysis. There is no placebo or comparator group.\n\nThe primary endpoint is the mean change in unanesthetized Schirmer score from pre-drop baseline to 3 minutes post-drop at Week 8. Secondary endpoints include acute change in Schirmer score on Day 1, change in neuropathic ocular symptom intensity on the VAS (Visual Analog Scale), and change in quality of life measured by OPAS (Ocular Pain Assessment Survey). Exploratory outcomes include changes in corneal nerve structure and function, corneal sensitivity, OSDI (Ocular Surface Disease Index) scores, drop comfort, and treatment satisfaction.\n\nSafety monitoring will focus on corneal staining, visual acuity, discomfort following drop administration, and adverse events, with a safety assessment conducted after the first five participants.",[34],{"label":35,"type":36,"description":37,"interventionNames":38},"Acoltremon Group","EXPERIMENTAL","Patients will administer one drop of Acoltremon Ophthalmic Solution 0.003% twice a day for 8 weeks.",[39],"Drug: acoltremon ophthalmic solution 0.003%",[41],{"type":42,"name":43,"description":44,"armGroupLabels":45,"otherNames":25},"DRUG","acoltremon ophthalmic solution 0.003%","acoltremon ophthalmic solution 0.003%, one drop, twice a day, into the study eye, for 8 weeks.",[35],[47],{"name":48,"affiliation":49,"role":50},"Pedram Hamrah, MD","University of South Florida\u002FOphthalmology","PRINCIPAL_INVESTIGATOR",[52,57],{"name":53,"role":54,"phone":55,"phoneExt":25,"email":56},"Mya L. Reese","CONTACT","18139742020","MCOM-Eyeresearch@usf.edu",{"name":58,"role":54,"phone":59,"phoneExt":25,"email":56},"Susan Sherouse","8139742020",[61],{"facility":62,"status":25,"city":63,"state":64,"zip":65,"country":66,"countryCode":67,"cosmosGeoPoint":68,"geoPoint":73,"contacts":74},"The University of South Florida","Tampa","Florida","33612","United States","US",{"type":69,"coordinates":70},"Point",[71,72],-82.45843,27.94752,{"lat":72,"lon":71},[75,78,80],{"name":76,"role":54,"phone":59,"phoneExt":25,"email":77},"Mya Reese","mreese179@usf.edu",{"name":58,"role":54,"phone":59,"phoneExt":25,"email":79},"ssherous@usf.edu",{"name":48,"role":50,"phone":25,"phoneExt":25,"email":25},{"type":82,"investigatorFullName":25,"investigatorTitle":25,"investigatorAffiliation":25,"oldNameTitle":25,"oldOrganization":25},"SPONSOR",[84],{"name":85,"class":86},"Alcon Research","INDUSTRY","100658280","phase-4-effect-of-acoltremon-ophthalmic-solution-0003-on-tear-production-and-symptoms-in-patients-with-tear-deficiency-and-concurrent-neuropathic-corneal-pain-100658280",false,"NCT07849803","Effect of Acoltremon Ophthalmic Solution 0.003% on Tear Production and Symptoms in Patients With Tear Deficiency and Concurrent Neuropathic Corneal Pain","AURORA","Inclusion Criteria:\n\n1. Male or female aged ≥ 18 years\n2. Baseline unanesthetized Schirmer test ≥2 and \\\u003C 10 mm\n3. Symptoms of neuropathic corneal pain (such as burning, stinging, light sensitivity, discomfort, or pain) for at least 3 months with driving symptom rated at level 4 or higher on VAS.\n4. Positive IVCM findings evaluated by an experienced ophthalmologist (Pedram Hamrah, MD): for decreased nerve density AND evidence of microneuromas.\n5. Females of childbearing potential must have a negative pregnancy test.\n6. Change of 50% or more improvement in VAS score after topical 0.5% proparacaine hydrochloride (Alcaine, Alcon, Fort Worth, TX).\n\nExclusion Criteria:\n\n1. Evidence of any active ocular infection or any intraocular inflammation.\n2. Evidence of any persistent epithelial defect\u002Fulcer or any corneal scar\u002Fcorneal edema.\n3. Presence of any other ocular conditions that require topical medications during the treatment phase.\n4. History of severe systemic allergies or severe ocular allergies.\n5. Inability to suspend topical medications and varenicline 8 days prior to the starting date, except for artificial and serum tears for which subjects must be stable on current regimen for ≥3 months with no changes during the trial.\n6. History of any ocular surgery within three months before study Visit 1.\n7. Ocular surgery expected during the duration of the study.\n8. Use of refractive\u002Ftherapeutic contact lenses during the study period.\n9. Female subjects who are pregnant\u002Fhave a positive pregnancy test result or are breastfeeding or intend to become pregnant during the study treatment period.\n10. Drug addiction\u002Falcohol abuse within the last year.\n11. Participation in another clinical trial concurrently.","ALL","18 Years",{"count":97,"type":98},28,"ESTIMATED","INTERVENTIONAL",[101],"PHASE4","This study is designed to provide clinical data on how acoltremon ophthalmic solution 0.003% affects tear production and ocular symptoms in participants with tear deficiency and concurrent neuropathic corneal pain. Acoltremon is formulated to help increase natural tear production by activating TRPM8 (Transient Receptor Potential Melastatin 8) receptors on cold-sensitive corneal nerves. It is thought that this study treatment may help participants by increasing tear production while potentially reducing neuropathic ocular symptoms, including pain and discomfort.\n\nParticipants will be followed for 8 weeks, evaluating the mean change in unanesthetized Schirmer test score between 3 minutes post-drop at Week 8 compared to pre-drop at baseline (Day 1), change in neuropathic symptom intensity as measured by a 0-10 VAS (Visual Analog Scale) from baseline to Week 8, and change in quality of life as assessed by the Ocular Pain Assessment Survey (OPAS) from baseline to Week 8. The study will also evaluate changes in corneal nerve structure, nerve function, corneal sensitivity, ocular surface symptoms, and treatment satisfaction.",[104,105],"Ocular Pain","Dry Eye",[105,107,108],"Eye pain","tear deficiency","NOT_YET_RECRUITING","2026-10-01",{"date":112,"type":113},"2026-10-06","ACTUAL",{"date":115,"type":98},"2026-10",{"date":117,"type":98},"2027-06",{"name":5,"class":6},1]