[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100505751":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":26,"centralContacts":26,"locations":30,"responsibleParty":101,"collaborators":26,"id":103,"slug":26,"hasResults":104,"nctId":105,"briefTitle":106,"officialTitle":107,"acronym":108,"eligibilityCriteria":109,"healthyVolunteers":104,"sex":110,"minAge":111,"maxAge":26,"enrollmentInfo":112,"targetDuration":26,"studyType":115,"phases":116,"briefSummary":118,"conditions":119,"keywords":26,"overallStatus":33,"whyStopped":26,"lastUpdateSubmitDate":121,"lastUpdatePostDateStruct":122,"startDateStruct":125,"completionDateStruct":127,"leadSponsor":129,"locationsCount":130},{"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],[31,48,61,75,88],{"facility":32,"status":33,"city":34,"state":26,"zip":26,"country":35,"cosmosGeoPoint":36,"geoPoint":41,"contacts":42},"Medical University Graz","RECRUITING","Graz","Austria",{"type":37,"coordinates":38},"Point",[39,40],15.44197,47.06733,{"lat":40,"lon":39},[43],{"name":44,"role":45,"phone":46,"phoneExt":26,"email":47},"Jutta Horwath-Winter, Dr","CONTACT","+43 316 385 80807","jutta.horwath@medunigraz.at",{"facility":49,"status":33,"city":50,"state":26,"zip":26,"country":35,"cosmosGeoPoint":51,"geoPoint":55,"contacts":56},"VIROS","Vienna",{"type":37,"coordinates":52},[53,54],16.37208,48.20849,{"lat":54,"lon":53},[57],{"name":58,"role":45,"phone":59,"phoneExt":26,"email":60},"Stefan Palkovits, Dr","+43 1 91 021 57573","stefan.palkovits@oegk.at",{"facility":62,"status":33,"city":63,"state":26,"zip":26,"country":64,"cosmosGeoPoint":65,"geoPoint":69,"contacts":70},"CHRU Brest","Brest","France",{"type":37,"coordinates":66},[67,68],-4.48628,48.39029,{"lat":68,"lon":67},[71],{"name":72,"role":45,"phone":73,"phoneExt":26,"email":74},"Beatrice Cochener, Prof.","+33 2 98 22 34 40","beatrice.cochener@univ-brest.fr",{"facility":76,"status":33,"city":77,"state":26,"zip":26,"country":64,"cosmosGeoPoint":78,"geoPoint":82,"contacts":83},"Hôpital Bicêtre","Le Kremlin-Bicêtre",{"type":37,"coordinates":79},[80,81],2.36073,48.81471,{"lat":81,"lon":80},[84],{"name":85,"role":45,"phone":86,"phoneExt":26,"email":87},"Marc Labetoulle","+33 1 45 21 36 90","marc.labetoulle@aphp.fr",{"facility":89,"status":33,"city":90,"state":26,"zip":26,"country":64,"cosmosGeoPoint":91,"geoPoint":95,"contacts":96},"CHU Nice","Nice",{"type":37,"coordinates":92},[93,94],7.26608,43.70313,{"lat":94,"lon":93},[97],{"name":98,"role":45,"phone":99,"phoneExt":26,"email":100},"Stéphanie Baillif, Prof.","+33 4 92 03 8025","baillif.s@chu-nice.fr",{"type":102,"investigatorFullName":26,"investigatorTitle":26,"investigatorAffiliation":26,"oldNameTitle":26,"oldOrganization":26},"SPONSOR","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":113,"type":114},80,"ESTIMATED","INTERVENTIONAL",[117],"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.",[120],"Dry Eye Disease","2026-06-01",{"date":123,"type":124},"2026-06-03","ACTUAL",{"date":126,"type":124},"2025-09-25",{"date":128,"type":114},"2027-06",{"name":5,"class":6},5]