{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,2,19]],"date-time":"2026-02-19T08:25:04Z","timestamp":1771489504049,"version":"3.50.1"},"reference-count":15,"publisher":"Wiley","issue":"2","license":[{"start":{"date-parts":[[2016,7,22]],"date-time":"2016-07-22T00:00:00Z","timestamp":1469145600000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"content-domain":{"domain":["aao-hnsfjournals.onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Otolaryngol.--head neck surg."],"published-print":{"date-parts":[[2016,8]]},"abstract":"<jats:sec><jats:title>Objective<\/jats:title><jats:p>To investigate the efficacy, safety, and microbiology of a thermosensitive otic suspension of ciprofloxacin (OTO\u2010201) in children with bilateral middle ear effusion undergoing tympanostomy tube placement.<\/jats:p><\/jats:sec><jats:sec><jats:title>Study Design<\/jats:title><jats:p>Two randomized, double\u2010blind, sham\u2010controlled phase 3 trials. Patients were randomized to intratympanic OTO\u2010201 or sham.<\/jats:p><\/jats:sec><jats:sec><jats:title>Setting<\/jats:title><jats:p>Children with bilateral middle ear effusion undergoing tympanostomy tube placement.<\/jats:p><\/jats:sec><jats:sec><jats:title>Subjects\/Methods<\/jats:title><jats:p>Studies evaluated 532 patients (6\u00a0months to 17 years old) in a combined analysis of efficacy (treatment failure: presence of otorrhea, otic or systemic antibiotic use, lost to follow\u2010up, missed visits), safety (audiometry, otoscopy, tympanometry), and microbiology.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>There was a lower cumulative proportion of treatment failures in patients receiving OTO\u2010201 vs tympanostomy tubes alone (1) on days 4, 8, 15, and 29; (2) on day 15, primary end point (23.0% vs 45.1%; age\u2010adjusted odds ratio, 0.341; <jats:italic>P<\/jats:italic> &lt;. 001; reduction in relative risk, 49%); and (3) on day 15, blinded\u2010assessor otorrhea treatment failure (7.0% vs 19.4%; age\u2010adjusted odds ratio, 0.303; <jats:italic>P<\/jats:italic> &lt;. 001; reduction in relative risk, 64%). Per\u2010protocol and subgroup analyses (baseline demographics, pathogen type, culture status, effusion type, microbiologic response) supported these findings. There were no drug\u2010related serious adverse events; the most frequent treatment\u2010emergent adverse events in both groups were pyrexia, postoperative pain, nasopharyngitis, cough, and upper respiratory tract infection. OTO\u2010201 administration had no evidence of increased tube occlusion and no negative effect on audiometry, tympanometry, or otoscopy.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusions<\/jats:title><jats:p>Combined analysis of 2\u00a0phase 3 trials demonstrated a lower cumulative proportion of treatment failures through day 15 compared with TT alone when OTO\u2010201 was administered intratympanically for otitis media with bilateral middle ear effusion at time of tympanostomy tube placement.<\/jats:p><\/jats:sec>","DOI":"10.1177\/0194599816645526","type":"journal-article","created":{"date-parts":[[2016,5,17]],"date-time":"2016-05-17T23:29:21Z","timestamp":1463527761000},"page":"324-331","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":15,"title":["Phase 3 Trials of Thermosensitive Ciprofloxacin Gel for Middle Ear Effusion in Children with Tubes"],"prefix":"10.1002","volume":"155","author":[{"given":"Albert H.","family":"Park","sequence":"first","affiliation":[{"name":"Department of Surgery and Pediatrics University of Utah Salt Lake City Utah USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"David R.","family":"White","sequence":"additional","affiliation":[{"name":"Medical University of South Carolina Charleston South Carolina USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Jonathan R.","family":"Moss","sequence":"additional","affiliation":[{"name":"Charlotte Eye, Ear, Nose, and Throat Associates Charlotte North Carolina USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Moraye","family":"Bear","sequence":"additional","affiliation":[{"name":"Forsythe and Bear, LLC Woodlands California USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Carl","family":"LeBel","sequence":"additional","affiliation":[{"name":"Otonomy, Inc San Diego California USA"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"311","published-online":{"date-parts":[[2016,7,22]]},"reference":[{"key":"e_1_2_10_2_1","doi-asserted-by":"publisher","DOI":"10.1177\/014556130508400712"},{"key":"e_1_2_10_3_1","doi-asserted-by":"publisher","DOI":"10.1371\/journal.pone.0036226"},{"key":"e_1_2_10_4_1","first-page":"1","article-title":"Ambulatory and inpatient procedures in the United States, 1996","volume":"139","author":"Owings MF","year":"1998","journal-title":"Vital Health Stat"},{"key":"e_1_2_10_5_1","doi-asserted-by":"publisher","DOI":"10.1177\/0194599811409862"},{"key":"e_1_2_10_6_1","doi-asserted-by":"publisher","DOI":"10.1542\/peds.107.6.1251"},{"key":"e_1_2_10_7_1","doi-asserted-by":"publisher","DOI":"10.1067\/mhn.2001.113941"},{"key":"e_1_2_10_8_1","first-page":"CD008512","article-title":"Interventions for the prevention of postoperative ear discharge after insertion of ventilation tubes (grommets) in children","volume":"4","author":"Syed MI","year":"2013","journal-title":"Cochrane Database Syst Rev"},{"key":"e_1_2_10_9_1","doi-asserted-by":"publisher","DOI":"10.1177\/0194599811399711"},{"key":"e_1_2_10_10_1","doi-asserted-by":"publisher","DOI":"10.1001\/jamaoto.2016.0001"},{"key":"e_1_2_10_11_1","volume-title":"Efficacy demonstrated in two phase 3 clinical trials of intratympanic extended\u2010release ciprofloxacin gel in children with middle ear effusion undergoing tympanostomy tube placement","author":"Park A","year":"2015"},{"key":"e_1_2_10_12_1","doi-asserted-by":"publisher","DOI":"10.1097\/MAO.0000000000000261"},{"key":"e_1_2_10_13_1","doi-asserted-by":"publisher","DOI":"10.1177\/0003489415599001"},{"key":"e_1_2_10_14_1","volume-title":"(ciprofloxacin 0.3% \/ dexamethasone 0.1%) sterile otic suspension [package insert]","author":"CIPRODEX","year":"2009"},{"key":"e_1_2_10_15_1","unstructured":"Patient\u2010Centered Outcomes Research Institute.http:\/\/www.pcori.org\/. 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