[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100084421":3},{"organization":4,"armGroups":7,"interventions":8,"overallOfficials":12,"centralContacts":7,"locations":7,"responsibleParty":7,"collaborators":7,"id":17,"slug":18,"hasResults":19,"nctId":20,"briefTitle":21,"officialTitle":22,"acronym":7,"eligibilityCriteria":23,"healthyVolunteers":19,"sex":24,"minAge":25,"maxAge":26,"enrollmentInfo":7,"targetDuration":7,"studyType":27,"phases":28,"briefSummary":30,"conditions":31,"keywords":7,"overallStatus":33,"whyStopped":7,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":35,"startDateStruct":38,"completionDateStruct":40,"leadSponsor":42,"locationsCount":7},{"fullName":5,"class":6},"Laboratoires Thea","INDUSTRY",null,[9],{"type":10,"name":11,"description":7,"armGroupLabels":7,"otherNames":7},"DRUG","Azithromycin",[13],{"name":14,"affiliation":15,"role":16},"Isabelle COCHEREAU, Professor","CHU d'Angers, France","PRINCIPAL_INVESTIGATOR","100084421","phase-3-efficacy-and-safety-of-2-dosing-regimens-of-t1225-eye-drops-15-versus-oral-azithromycin-in-treatment-of-trachoma-100084421",false,"NCT00356720","Efficacy and Safety of 2 Dosing Regimens of T1225 Eye Drops 1.5% Versus Oral Azithromycin in Treatment of Trachoma","Clinical Efficacy and Safety of 2 Dosing Regimens of T1225 Eye Drops 1.5% (Instilled Twice Daily for 2 or 3 Days) Versus Oral Azithromycin in Treatment of Trachoma","Inclusion Criteria:\n\n* Male or female aged 1-10 years;\n* written informed consent by legally acceptable representative;\n* TF+ TI0 (trachomatous inflammation - follicular) or TF+TI+ (trachomatous inflammation - follicular and intense) on simplified World Health Organisation (WHO) grading system\n\nExclusion Criteria:\n\n* Trichiasis or corneal opacity;\n* palpebral deformation;\n* clinically significant ocular abnormality;\n* ocular infection;\n* organic amblyopia;\n* hypersensitivity to treatments' components;\n* immunosuppressive conditions;\n* systemic AZM or steroids;\n* topical ophthalmic antibiotics within 3 months;\n* other systemic antibiotics within 1 month;\n* topical (ocular, nasal, bronchial etc.) treatments within 1 week;\n* systemic non-steroidal anti-inflammatory drugs on day before Day 0","ALL","1 Year","10 Years","INTERVENTIONAL",[29],"PHASE3","To assess in children the efficacy and safety of 2 dosing regimens of T1225 1.5% eye drops, in comparison to a reference product, single-dose oral azithromycin (AZM) 20 mg\u002Fkg, for the treatment of active trachoma. Evaluation of clinical efficacy was primary (% of clinical cure at Day 60 in Per Protocol Set), microbiological evaluation was secondary",[32],"Trachoma","COMPLETED","2006-07-25",{"date":36,"type":37},"2006-07-26","ESTIMATED",{"date":39,"type":7},"2004-01",{"date":41,"type":7},"2004-05",{"name":5,"class":6}]