[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100202214":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":30,"centralContacts":24,"locations":24,"responsibleParty":34,"collaborators":24,"id":36,"slug":37,"hasResults":38,"nctId":39,"briefTitle":40,"officialTitle":41,"acronym":24,"eligibilityCriteria":42,"healthyVolunteers":43,"sex":44,"minAge":45,"maxAge":46,"enrollmentInfo":47,"targetDuration":24,"studyType":50,"phases":51,"briefSummary":53,"conditions":54,"keywords":56,"overallStatus":61,"whyStopped":62,"lastUpdateSubmitDate":63,"lastUpdatePostDateStruct":64,"startDateStruct":66,"completionDateStruct":68,"leadSponsor":70,"locationsCount":24},{"fullName":5,"class":6},"Alcon Research","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"AL-60371\u002FAL-817","EXPERIMENTAL","AL-60371\u002FAL-817 otic suspension, 200 μL in affected ear(s) through tympanostomy tube on Day 1 (Visit 1)",[13],"Drug: AL-60371\u002FAL-817 otic suspension",{"label":15,"type":16,"description":17,"interventionNames":18},"CIPRODEX","ACTIVE_COMPARATOR","Ciprofloxacin 0.3%\u002Fdexamethasone 0.1% otic suspension, 4 drops in affected ear(s) twice daily through tympanostomy tube for 7 days",[19],"Drug: Ciprofloxacin 0.3%\u002Fdexamethasone 0.1% otic suspension",[21,26],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":24},"DRUG","AL-60371\u002FAL-817 otic suspension",null,[9],{"type":22,"name":27,"description":28,"armGroupLabels":29,"otherNames":24},"Ciprofloxacin 0.3%\u002Fdexamethasone 0.1% otic suspension","CIPRODEX®",[15],[31],{"name":32,"affiliation":5,"role":33},"Clinical Manager, GCRA, Pharma","STUDY_DIRECTOR",{"type":35,"investigatorFullName":24,"investigatorTitle":24,"investigatorAffiliation":24,"oldNameTitle":24,"oldOrganization":24},"SPONSOR","100202214","phase-2-proof-of-concept-study-of-a-single-application-of-an-investigational-otic-suspension-in-treatment-of-acute-otitis-media-with-tympanostomy-tubes-100202214",true,"NCT01908803","Proof-of-Concept Study of a Single Application of an Investigational Otic Suspension in Treatment of Acute Otitis Media With Tympanostomy Tubes","Proof of Concept of Single Application of AL-60371\u002FAL-817 Otic Suspension in Treatment of Acute Otitis Media With Tympanostomy Tubes Compared to CIPRODEX® (BID for 7 Days)","Inclusion Criteria:\n\n* Parent or guardian: Read and sign the informed consent. When required by the Institutional Review Board, child must agree to sign an approved assent form;\n* Presence of otorrhea (visible by parent or guardian) of 21 days or less in duration;\n* Presence of patent tympanostomy tubes;\n* Refrain from water immersion of the ears following surgery without the use of adequate ear protection during swimming, bathing, showering and other water-related activities;\n* Parent or guardian: Agree to comply with the requirements of the study, administer the study medication as directed, complete required study visits, and comply with the protocol;\n* Other protocol-defined inclusion criteria may apply.\n\nExclusion Criteria:\n\n* NOT otorrhea-free for at least seven days following tympanostomy tube surgery;\n* Menarcheal females;\n* Previous otologic surgery, except tympanic membrane, within one year of study entry;\n* History of\u002For current acute or chronic non-tube otorrhea (through existing perforation of the eardrum);\n* Current acute otitis externa, malignant otitis externa, or other conditions which could interfere with evaluation of the study drug;\n* Diabetic (controlled or uncontrolled);\n* Use of prohibited medications;\n* Other protocol-defined exclusion criteria may apply.",false,"ALL","6 Months","12 Years",{"count":48,"type":49},84,"ACTUAL","INTERVENTIONAL",[52],"PHASE2","The purpose of this study is to evaluate a single application of AL-60371\u002FAL-817 Otic Suspension relative to ototopical CIPRODEX for sustained clinical cure, microbiological success, and time to cessation of otorrhea.",[55],"Acute Otitis Media",[57,58,59,60],"AOMT","tympanostomy tubes","Otorrhea","anti-infective","TERMINATED","Management decision","2017-11-02",{"date":65,"type":49},"2017-12-06",{"date":67,"type":24},"2013-12",{"date":69,"type":49},"2014-08",{"name":5,"class":6}]