{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,7,20]],"date-time":"2026-07-20T09:15:39Z","timestamp":1784538939300,"version":"3.55.0"},"reference-count":14,"publisher":"SAGE Publications","issue":"2","license":[{"start":{"date-parts":[[2015,8,20]],"date-time":"2015-08-20T00:00:00Z","timestamp":1440028800000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/journals.sagepub.com\/page\/policies\/text-and-data-mining-license"}],"content-domain":{"domain":["journals.sagepub.com"],"crossmark-restriction":true},"short-container-title":["Ann Otol Rhinol Laryngol"],"published-print":{"date-parts":[[2016,2]]},"abstract":"<jats:sec>\n                    <jats:title>Objective:<\/jats:title>\n                    <jats:p>This exploratory clinical trial evaluated the safety and clinical activity of a novel, sustained-exposure formulation of ciprofloxacin microparticulates in poloxamer (OTO-201) administered during tympanostomy tube placement in children.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods:<\/jats:title>\n                    <jats:p>Double-blind, randomized, prospective, placebo- and sham-controlled, multicenter Phase 1b trial in children (6 months to 12 years) with bilateral middle ear effusion requiring tympanostomy tube placement. Patients were randomized to intraoperative OTO-201 (4 mg or 12 mg), placebo, or sham (2:1:1 ratio).<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results:<\/jats:title>\n                    <jats:p>Eighty-three patients (52 male\/31 female; mean age, 2.80 years) were followed for safety (otoscopic exams, cultures, audiometry, and tympanometry) and clinical activity, defined as treatment failure (physician-documented otorrhea and\/or otic or systemic antibiotic use \u22653 days post surgery). At baseline, 14.3% to 36.8% of children showed positive cultures of middle ear effusion samples in at least 1 ear. Through day 15, treatment failures accounted for 14.3%, 15.8%, 45.5%, and 42.9% of patients (OTO-201 4 mg, OTO-201 12 mg, placebo, and sham, respectively); treatment failure reductions for OTO-201 doses were significant compared to pooled control ( P values = .023 and .043, respectively). Observed OTO-201 safety profile was indistinguishable from placebo or sham.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions:<\/jats:title>\n                    <jats:p>Results of this first clinical trial suggest that OTO-201 was well tolerated and shows preliminary clinical activity in treating tympanostomy tube otorrhea.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1177\/0003489415599001","type":"journal-article","created":{"date-parts":[[2015,8,21]],"date-time":"2015-08-21T20:28:58Z","timestamp":1440188938000},"page":"105-114","update-policy":"https:\/\/doi.org\/10.1177\/sage-journals-update-policy","source":"Crossref","is-referenced-by-count":10,"title":["Randomized Clinical Trial of a Sustained-Exposure Ciprofloxacin for Intratympanic Injection During Tympanostomy Tube Surgery"],"prefix":"10.1177","volume":"125","author":[{"given":"Eric A.","family":"Mair","sequence":"first","affiliation":[{"name":"Charlotte Eye, Ear, Nose, and Throat Associates, Charlotte, North Carolina, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jonathan R.","family":"Moss","sequence":"additional","affiliation":[{"name":"Charlotte Eye, Ear, Nose, and Throat Associates, Charlotte, North Carolina, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Joseph E.","family":"Dohar","sequence":"additional","affiliation":[{"name":"Children\u2019s Hospital of Pittsburgh, UPMC, Pittsburgh, Pennsylvania, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Patrick J.","family":"Antonelli","sequence":"additional","affiliation":[{"name":"Department of Otolaryngology, University of Florida, Gainesville, Florida, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Moraye","family":"Bear","sequence":"additional","affiliation":[{"name":"Forsythe and Bear, LLC, Woodland Hills, California, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Carl","family":"LeBel","sequence":"additional","affiliation":[{"name":"Otonomy, Inc, San Diego, California, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"179","published-online":{"date-parts":[[2015,8,20]]},"reference":[{"issue":"139","key":"bibr1-0003489415599001","first-page":"1","volume":"13","author":"Owings MF","year":"1998","journal-title":"Vital Health Stat"},{"key":"bibr2-0003489415599001","doi-asserted-by":"publisher","DOI":"10.1177\/0194599811409862"},{"key":"bibr3-0003489415599001","doi-asserted-by":"publisher","DOI":"10.1542\/peds.107.6.1251"},{"issue":"4","key":"bibr4-0003489415599001","first-page":"416","volume":"20","author":"Zipfel TE","year":"1999","journal-title":"Am J Otol"},{"key":"bibr5-0003489415599001","doi-asserted-by":"publisher","DOI":"10.1001\/archotol.1995.01890040069011"},{"key":"bibr6-0003489415599001","doi-asserted-by":"publisher","DOI":"10.1097\/MAO.0000000000000261"},{"key":"bibr7-0003489415599001","unstructured":"Alcon, Inc. CIPRODEX (ciprofloxacin 0.3% and dexamethasone 0.1%) sterile otic suspension. 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