[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100505751":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":26,"centralContacts":26,"locations":30,"responsibleParty":103,"collaborators":26,"id":105,"slug":106,"hasResults":107,"nctId":108,"briefTitle":109,"officialTitle":110,"acronym":111,"eligibilityCriteria":112,"healthyVolunteers":107,"sex":113,"minAge":114,"maxAge":26,"enrollmentInfo":115,"targetDuration":26,"studyType":118,"phases":119,"briefSummary":121,"conditions":122,"keywords":26,"overallStatus":33,"whyStopped":26,"lastUpdateSubmitDate":124,"lastUpdatePostDateStruct":125,"startDateStruct":128,"completionDateStruct":130,"leadSponsor":132,"locationsCount":133},{"fullName":5,"class":6},"TRB Chemedica International SA","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"BUFY02","EXPERIMENTAL","0.3% Sodium Hyaluronate (trometamol buffer) in single-dose containers of 0.45 mL",[13],"Device: BUFY02 eye drops in single-dose containers",{"label":15,"type":16,"description":17,"interventionNames":18},"TRB02","ACTIVE_COMPARATOR","0.3% Sodium Hyaluronate (phosphate buffer) in single-dose containers of 0.45 mL",[19],"Device: TRB02 eye drops in single-dose containers",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DEVICE","BUFY02 eye drops in single-dose containers","1 to 2 drops in each eye, as often as needed",[9],null,{"type":22,"name":28,"description":24,"armGroupLabels":29,"otherNames":26},"TRB02 eye drops in single-dose containers",[15],[31,49,62,77,90],{"facility":32,"status":33,"city":34,"state":26,"zip":26,"country":35,"countryCode":36,"cosmosGeoPoint":37,"geoPoint":42,"contacts":43},"Medical University Graz","RECRUITING","Graz","Austria","AT",{"type":38,"coordinates":39},"Point",[40,41],15.44197,47.06733,{"lat":41,"lon":40},[44],{"name":45,"role":46,"phone":47,"phoneExt":26,"email":48},"Jutta Horwath-Winter, Dr","CONTACT","+43 316 385 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Kremlin-Bicêtre",{"type":38,"coordinates":81},[82,83],2.36073,48.81471,{"lat":83,"lon":82},[86],{"name":87,"role":46,"phone":88,"phoneExt":26,"email":89},"Marc Labetoulle","+33 1 45 21 36 90","marc.labetoulle@aphp.fr",{"facility":91,"status":33,"city":92,"state":26,"zip":26,"country":65,"countryCode":66,"cosmosGeoPoint":93,"geoPoint":97,"contacts":98},"CHU Nice","Nice",{"type":38,"coordinates":94},[95,96],7.26608,43.70313,{"lat":96,"lon":95},[99],{"name":100,"role":46,"phone":101,"phoneExt":26,"email":102},"Stéphanie Baillif, Prof.","+33 4 92 03 8025","baillif.s@chu-nice.fr",{"type":104,"investigatorFullName":26,"investigatorTitle":26,"investigatorAffiliation":26,"oldNameTitle":26,"oldOrganization":26},"SPONSOR","100505751","efficacy-and-safety-of-bufy02-versus-trb02-in-the-treatment-of-dry-eye-disease-100505751",false,"NCT05865457","Efficacy and Safety of BUFY02 Versus TRB02 in the Treatment of Dry Eye Disease","Efficacy and Safety of BUFY02 Versus TRB02 in the Treatment of Dry Eye Disease: a Non-inferiority Investigation","BUSTON-02","Inclusion Criteria include:\n\n* At least a 3-month documented history of bilateral dry eye syndrome needing artificial tears;\n* At least one eye with Oxford score ≥ 4 and ≤ 9;\n* At least one objective sign of tear deficiency (in at least one eligible eye);\n* Having a health insurance.\n\nExclusion Criteria include:\n\n* Wear of contact lenses starting within the last 2 months;\n* Best-corrected visual acuity (BCVA) \\> 1.00;\n* Severe DED with one of the listed conditions:\n* Severe blepharitis;\n* Seasonal allergy;\n* Any issues of the ocular surface not related to DED;\n* History of ocular trauma, infection or inflammation not related to DED;\n* History of ocular surgery, including laser surgery;\n* Unstable glaucoma;\n* Use of artificial tears with preservative within the last 2 weeks;\n* Systemic (enteral or parenteral) or local (topical) use of one of the listed medications:\n* Known hypersensitivity to any constituent of the study treatments;\n* Pregnancy or breastfeeding;\n* Participation in another clinical study within the last 90 days;\n* Legally restricted autonomy, freedom of decision and action.","ALL","18 Years",{"count":116,"type":117},80,"ESTIMATED","INTERVENTIONAL",[120],"NA","The goal of this interventional investigation is to compare BUFY02 with TRB02 in the treatment of patients with dry eye disease. The main questions it aims to answer are:\n\n* Is BUFY02 non-inferior to TRB02 in terms of signs of DED?\n* Is BUFY02 non-inferior to TRB02 in terms of symptoms of DED?\n\nParticipants will be asked to:\n\n* Visit the trial site at 4 different timepoints\n* Use the allocated study treatment everyday until the end of the study (during 3 months)\n* Be examined by the investigator\n* Complete several questionnaires\n* Return unused study treatment.\n\nResearchers will compare BUFY02 to TRB02 to see if both study treatments provide similar effects on signs and symptoms of the disease, together with comparable safety.",[123],"Dry Eye Disease","2026-06-01",{"date":126,"type":127},"2026-06-03","ACTUAL",{"date":129,"type":127},"2025-09-25",{"date":131,"type":117},"2027-06",{"name":5,"class":6},5]