Randomized Clinical Trial of a Sustained-Exposure Ciprofloxacin for Intratympanic Injection During Tympanostomy Tube Surgery

Author:

Mair Eric A.1,Moss Jonathan R.1,Dohar Joseph E.2,Antonelli Patrick J.3,Bear Moraye4,LeBel Carl5

Affiliation:

1. Charlotte Eye, Ear, Nose, and Throat Associates, Charlotte, North Carolina, USA

2. Children’s Hospital of Pittsburgh, UPMC, Pittsburgh, Pennsylvania, USA

3. Department of Otolaryngology, University of Florida, Gainesville, Florida, USA

4. Forsythe and Bear, LLC, Woodland Hills, California, USA

5. Otonomy, Inc, San Diego, California, USA

Abstract

Objective: 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. Methods: 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). Results: 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 ≥3 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. Conclusions: Results of this first clinical trial suggest that OTO-201 was well tolerated and shows preliminary clinical activity in treating tympanostomy tube otorrhea.

Publisher

SAGE Publications

Subject

General Medicine,Otorhinolaryngology

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