[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100631684":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":25,"centralContacts":30,"locations":35,"responsibleParty":271,"collaborators":25,"id":273,"slug":274,"hasResults":275,"nctId":276,"briefTitle":277,"officialTitle":278,"acronym":25,"eligibilityCriteria":279,"healthyVolunteers":275,"sex":280,"minAge":281,"maxAge":25,"enrollmentInfo":282,"targetDuration":25,"studyType":285,"phases":286,"briefSummary":288,"conditions":289,"keywords":291,"overallStatus":38,"whyStopped":25,"lastUpdateSubmitDate":296,"lastUpdatePostDateStruct":297,"startDateStruct":300,"completionDateStruct":302,"leadSponsor":304,"locationsCount":305},{"fullName":5,"class":6},"Dompé Farmaceutici S.p.A","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"DFL24498","EXPERIMENTAL","Participants will receive DFL24498 opthalmic solution administered topically in both eyes.",[13],"Drug: DFL24498",{"label":15,"type":16,"description":17,"interventionNames":18},"Vehicle","PLACEBO_COMPARATOR","Participants will receive vehicle opthalmic solution administered topically in both eyes.",[19],"Other: Vehicle",[21,26],{"type":22,"name":9,"description":23,"armGroupLabels":24,"otherNames":25},"DRUG","One drop of reconstituted DFL24498 will be instilled topically in each eyes 4 times a day (QID) for 12 weeks.",[9],null,{"type":27,"name":15,"description":28,"armGroupLabels":29,"otherNames":25},"OTHER","One drop of reconstituted Vehicle will be instilled topically in each eyes QID for 12 weeks.",[15],[31],{"name":32,"role":33,"phone":34,"phoneExt":25,"email":25},"Dompé farmaceutici S.p.A. Via Santa Lucia, 6, 20122 Milan (MI)","CONTACT","+39 02 583 831",[36,50,60,69,78,88,97,106,116,125,135,145,155,165,174,184,193,202,212,222,232,242,251,261],{"facility":37,"status":38,"city":39,"state":40,"zip":41,"country":42,"countryCode":43,"cosmosGeoPoint":44,"geoPoint":49,"contacts":25},"Arizona Eye Center","RECRUITING","Chandler","Arizona","85224","United States","US",{"type":45,"coordinates":46},"Point",[47,48],-111.84125,33.30616,{"lat":48,"lon":47},{"facility":51,"status":38,"city":52,"state":53,"zip":54,"country":42,"countryCode":43,"cosmosGeoPoint":55,"geoPoint":59,"contacts":25},"Canyon City Eyecare","Azusa","California","91702",{"type":45,"coordinates":56},[57,58],-117.90756,34.13362,{"lat":58,"lon":57},{"facility":61,"status":38,"city":62,"state":53,"zip":63,"country":42,"countryCode":43,"cosmosGeoPoint":64,"geoPoint":68,"contacts":25},"Global Research Management, Inc.","Glendale","91204",{"type":45,"coordinates":65},[66,67],-118.25508,34.14251,{"lat":67,"lon":66},{"facility":70,"status":38,"city":71,"state":53,"zip":72,"country":42,"countryCode":43,"cosmosGeoPoint":73,"geoPoint":77,"contacts":25},"United Medical Research Institute","Inglewood","90301",{"type":45,"coordinates":74},[75,76],-118.35313,33.96168,{"lat":76,"lon":75},{"facility":79,"status":80,"city":81,"state":53,"zip":82,"country":42,"countryCode":43,"cosmosGeoPoint":83,"geoPoint":87,"contacts":25},"LoBue Laser and Eye Medical Center","NOT_YET_RECRUITING","Murrieta","82562",{"type":45,"coordinates":84},[85,86],-117.21392,33.55391,{"lat":86,"lon":85},{"facility":89,"status":38,"city":90,"state":53,"zip":91,"country":42,"countryCode":43,"cosmosGeoPoint":92,"geoPoint":96,"contacts":25},"Eye Research Foundation","Newport Beach","92663",{"type":45,"coordinates":93},[94,95],-117.92895,33.61891,{"lat":95,"lon":94},{"facility":98,"status":38,"city":99,"state":53,"zip":100,"country":42,"countryCode":43,"cosmosGeoPoint":101,"geoPoint":105,"contacts":25},"NVision Clinical Research, LLC","Torrance","90505",{"type":45,"coordinates":102},[103,104],-118.34063,33.83585,{"lat":104,"lon":103},{"facility":107,"status":80,"city":108,"state":109,"zip":110,"country":42,"countryCode":43,"cosmosGeoPoint":111,"geoPoint":115,"contacts":25},"Shettle Eye Research, Inc.","Largo","Florida","33773",{"type":45,"coordinates":112},[113,114],-82.78842,27.90979,{"lat":114,"lon":113},{"facility":117,"status":80,"city":118,"state":109,"zip":119,"country":42,"countryCode":43,"cosmosGeoPoint":120,"geoPoint":124,"contacts":25},"University of South Florida - Marshall Student Center","Tampa","33612",{"type":45,"coordinates":121},[122,123],-82.45843,27.94752,{"lat":123,"lon":122},{"facility":126,"status":38,"city":127,"state":128,"zip":129,"country":42,"countryCode":43,"cosmosGeoPoint":130,"geoPoint":134,"contacts":25},"Clayton Eye Clinical Research","Morrow","Georgia","30260",{"type":45,"coordinates":131},[132,133],-84.33937,33.58317,{"lat":133,"lon":132},{"facility":136,"status":38,"city":137,"state":138,"zip":139,"country":42,"countryCode":43,"cosmosGeoPoint":140,"geoPoint":144,"contacts":25},"Price Vision Group \u002F Cornea Research Foundation of America","Indianapolis","Indiana","46260",{"type":45,"coordinates":141},[142,143],-86.15804,39.76838,{"lat":143,"lon":142},{"facility":146,"status":80,"city":147,"state":148,"zip":149,"country":42,"countryCode":43,"cosmosGeoPoint":150,"geoPoint":154,"contacts":25},"Minnesota Eye Consultants","Minnetonka","Minnesota","55305",{"type":45,"coordinates":151},[152,153],-93.50329,44.9133,{"lat":153,"lon":152},{"facility":156,"status":80,"city":157,"state":158,"zip":159,"country":42,"countryCode":43,"cosmosGeoPoint":160,"geoPoint":164,"contacts":25},"Tekwani Vision Center","St Louis","Missouri","63128",{"type":45,"coordinates":161},[162,163],-90.19789,38.62727,{"lat":163,"lon":162},{"facility":166,"status":80,"city":167,"state":158,"zip":168,"country":42,"countryCode":43,"cosmosGeoPoint":169,"geoPoint":173,"contacts":25},"Comprehensive Eye Care, Ltd.","Washington","63090",{"type":45,"coordinates":170},[171,172],-91.01209,38.55811,{"lat":172,"lon":171},{"facility":175,"status":80,"city":176,"state":177,"zip":178,"country":42,"countryCode":43,"cosmosGeoPoint":179,"geoPoint":183,"contacts":25},"Asheville Eye Associates - Regional Medical Park","Asheville","North Carolina","28803",{"type":45,"coordinates":180},[181,182],-82.55402,35.60095,{"lat":182,"lon":181},{"facility":185,"status":38,"city":186,"state":177,"zip":187,"country":42,"countryCode":43,"cosmosGeoPoint":188,"geoPoint":192,"contacts":25},"Oculus Research, Inc.","Garner","27529",{"type":45,"coordinates":189},[190,191],-78.61417,35.71126,{"lat":191,"lon":190},{"facility":194,"status":80,"city":195,"state":177,"zip":196,"country":42,"countryCode":43,"cosmosGeoPoint":197,"geoPoint":201,"contacts":25},"Core, Inc.","Shelby","28150",{"type":45,"coordinates":198},[199,200],-81.53565,35.29235,{"lat":200,"lon":199},{"facility":203,"status":80,"city":204,"state":205,"zip":206,"country":42,"countryCode":43,"cosmosGeoPoint":207,"geoPoint":211,"contacts":25},"Cincinnati Eye Institute","Mason","Ohio","45040",{"type":45,"coordinates":208},[209,210],-84.30994,39.36006,{"lat":210,"lon":209},{"facility":213,"status":38,"city":214,"state":215,"zip":216,"country":42,"countryCode":43,"cosmosGeoPoint":217,"geoPoint":221,"contacts":25},"Scott & Christie and Associates, PC","Cranberry Township","Pennsylvania","16066",{"type":45,"coordinates":218},[219,220],-80.10714,40.68496,{"lat":220,"lon":219},{"facility":223,"status":38,"city":224,"state":225,"zip":226,"country":42,"countryCode":43,"cosmosGeoPoint":227,"geoPoint":231,"contacts":25},"Total Eye Care, PA - Memphis","Memphis","Tennessee","38119",{"type":45,"coordinates":228},[229,230],-90.04898,35.14953,{"lat":230,"lon":229},{"facility":233,"status":80,"city":234,"state":235,"zip":236,"country":42,"countryCode":43,"cosmosGeoPoint":237,"geoPoint":241,"contacts":25},"Houston Eye Associates","Houston","Texas","77025",{"type":45,"coordinates":238},[239,240],-95.36327,29.76328,{"lat":240,"lon":239},{"facility":243,"status":38,"city":244,"state":235,"zip":245,"country":42,"countryCode":43,"cosmosGeoPoint":246,"geoPoint":250,"contacts":25},"Lake Travis Eye and Laser Center","Lakeway","78738",{"type":45,"coordinates":247},[248,249],-97.97959,30.36377,{"lat":249,"lon":248},{"facility":252,"status":80,"city":253,"state":254,"zip":255,"country":42,"countryCode":43,"cosmosGeoPoint":256,"geoPoint":260,"contacts":25},"Alpine Research Organization, Inc.","Clinton","Utah","84015",{"type":45,"coordinates":257},[258,259],-112.0505,41.13967,{"lat":259,"lon":258},{"facility":262,"status":38,"city":263,"state":264,"zip":265,"country":42,"countryCode":43,"cosmosGeoPoint":266,"geoPoint":270,"contacts":25},"Piedmont Eye Center","Lynchburg","Virginia","24502",{"type":45,"coordinates":267},[268,269],-79.14225,37.41375,{"lat":269,"lon":268},{"type":272,"investigatorFullName":25,"investigatorTitle":25,"investigatorAffiliation":25,"oldNameTitle":25,"oldOrganization":25},"SPONSOR","100631684","phase-2-an-exploratory-efficacy-and-safety-study-of-dfl24498-topical-ophthalmic-solution-compared-with-vehicle-in-participants-with-dry-eye-disease-100631684",false,"NCT07503886","An Exploratory Efficacy and Safety Study of DFL24498 Topical Ophthalmic Solution Compared With Vehicle in Participants With Dry Eye Disease","A 12-Week, Phase 2, Multicenter, Randomized, Double-Masked, Vehicle Controlled, Parallel Group Study With 2 Weeks of Follow-Up to Evaluate the Efficacy and Safety of DFL24498 0.08% Topical Ophthalmic Solution Versus Vehicle in Participants With Dry Eye Disease","Key Inclusion Criteria:\n\n* A diagnosis of DED at least 6 months before enrollment (current use or recommended use of artificial tears for the treatment of dry eye).\n* The global score of the SANDE questionnaire ≥ 30\n* DED in at least one eye which is characterized by the following clinical features:\n\n  1. Schirmer I test without anesthesia \\\u003C 10 mm\u002F5 minutes, and\n  2. Total CFS grade ≥ 4 assessed by the NEI grading system, and\n  3. Fluorescein tear film break-up time (TFBUT) \\\u003C 10 seconds.\n* Best corrected visual acuity (BCVA) score on early treatment of diabetic retinopathy study (ETDRS) chart of ≥ 35 letters (corresponding to ≥ 0.1 Snellen decimal units or ≤ 1.0 Logarithm of the Minimum Angle of Resolution (Chart) \\[LogMAR\\]) in each eye at the time of study enrollment.\n* Only participants who satisfy all informed consent requirements will be included in the study.\n\nKey Exclusion Criteria:\n\n* Inability to speak and understand the local language sufficiently to understand the nature of the study, to provide written informed consent, and to allow the completion of all study assessments.\n* Evidence of an active ocular infection in either eye.\n* Anticipated need for ocular surgery during the study period, or any prior ocular surgery for 6 months prior to screening.\n* Intraocular inflammation defined as anterior chamber cell or flare \\> 0 by Standardization of Uveitis Nomenclature (SUN) grading in either eye.\n* Known or suspected ocular malignancy (ocular surface, intraocular, ocular adnexa) in either eye.\n\nNote: Additional protocol defined Inclusion\u002FExclusion criteria apply.","ALL","18 Years",{"count":283,"type":284},417,"ESTIMATED","INTERVENTIONAL",[287],"PHASE2","This is a Phase 2, randomized, multicenter, double masked, vehicle controlled, parallel group study to evaluate the efficacy and safety of DFL24498 topical ophthalmic solution versus vehicle in participants with dry eye disease. Approximately 417 participants aged 18 years or older who meet all eligibility criteria will be enrolled at study sites in the US. The study duration will be up to 16 weeks and will consist of three periods.",[290],"Dry Eye Disease (DED)",[292,9,293,294,295],"Dry Eye Disease","Ocular discomfort","Eye dryness","Topical ophthalmic solution","2026-06-23",{"date":298,"type":299},"2026-06-26","ACTUAL",{"date":301,"type":299},"2026-05-12",{"date":303,"type":284},"2027-02-07",{"name":5,"class":6},24]