[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100505745":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":26,"centralContacts":26,"locations":30,"responsibleParty":62,"collaborators":26,"id":64,"slug":65,"hasResults":66,"nctId":67,"briefTitle":68,"officialTitle":69,"acronym":70,"eligibilityCriteria":71,"healthyVolunteers":66,"sex":72,"minAge":73,"maxAge":26,"enrollmentInfo":74,"targetDuration":26,"studyType":77,"phases":78,"briefSummary":80,"conditions":81,"keywords":26,"overallStatus":33,"whyStopped":26,"lastUpdateSubmitDate":83,"lastUpdatePostDateStruct":84,"startDateStruct":87,"completionDateStruct":89,"leadSponsor":91,"locationsCount":92},{"fullName":5,"class":6},"TRB Chemedica International SA","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"BUFY01","EXPERIMENTAL","0.18% Sodium Hyaluronate (trometamol buffer) in single-dose containers of 0.3 mL",[13],"Device: BUFY01 eye drops in single-dose containers",{"label":15,"type":16,"description":17,"interventionNames":18},"SVS20","ACTIVE_COMPARATOR","0.18% Sodium Hyaluronate (phosphate buffer) in single-dose containers of 0.3 mL",[19],"Device: SVS20 eye drops in single-dose containers",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DEVICE","BUFY01 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},"SVS20 eye drops in single-dose containers",[15],[31,49],{"facility":32,"status":33,"city":34,"state":26,"zip":26,"country":35,"countryCode":36,"cosmosGeoPoint":37,"geoPoint":42,"contacts":43},"Hôpital des Quinze-Vingts","RECRUITING","Paris","France","FR",{"type":38,"coordinates":39},"Point",[40,41],2.3488,48.85341,{"lat":41,"lon":40},[44],{"name":45,"role":46,"phone":47,"phoneExt":26,"email":48},"Christiophe Baudouin","CONTACT","+33 1 40 02 13 06","cbaudouin@15-20.fr",{"facility":50,"status":33,"city":51,"state":26,"zip":26,"country":35,"countryCode":36,"cosmosGeoPoint":52,"geoPoint":56,"contacts":57},"CHU Saint-Etienne","Saint-Priest-en-Jarez",{"type":38,"coordinates":53},[54,55],4.37678,45.4739,{"lat":55,"lon":54},[58],{"name":59,"role":46,"phone":60,"phoneExt":26,"email":61},"Philippe Gain","+33 4 77 12 77 93","philippe.gain@univ-st-etienne.fr",{"type":63,"investigatorFullName":26,"investigatorTitle":26,"investigatorAffiliation":26,"oldNameTitle":26,"oldOrganization":26},"SPONSOR","100505745","efficacy-and-safety-of-bufy01-versus-svs20-in-the-treatment-of-dry-eye-disease-100505745",false,"NCT05865379","Efficacy and Safety of BUFY01 Versus SVS20 in the Treatment of Dry Eye Disease","Efficacy and Safety of BUFY01 Versus SVS20 in the Treatment of Dry Eye Disease: a Non-inferiority Investigation","BUSTON-01","Inclusion Criteria includes:\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 includes:\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":75,"type":76},80,"ESTIMATED","INTERVENTIONAL",[79],"NA","The goal of this interventional investigation is to compare BUFY01 with SVS20 in the treatment of patients with dry eye disease. The main questions it aims to answer are:\n\n* Is BUFY01 non-inferior to SVS20 in terms of signs of DED?\n* Is BUFY01 non-inferior to SVS20 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 BUFY01 to SVS20 to see if both study treatments provide similar effects on signs and symptoms of the disease, together with comparable safety.",[82],"Dry Eye Disease","2026-06-01",{"date":85,"type":86},"2026-06-03","ACTUAL",{"date":88,"type":76},"2026-06",{"date":90,"type":76},"2027-06",{"name":5,"class":6},2]