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Randomized Controlled Trial
. 2016 Feb;125(2):105-14.
doi: 10.1177/0003489415599001. Epub 2015 Aug 20.

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

Eric A Mair  1 , Jonathan R Moss  2 , Joseph E Dohar  3 , Patrick J Antonelli  4 , Moraye Bear  5 , Carl LeBel  6
Affiliations
Randomized Controlled Trial

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

Eric A Mair et al. Ann Otol Rhinol Laryngol. 2016 Feb.

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.

Keywords: OTO-201; ciprofloxacin; culture; middle ear effusion; otitis media; otorrhea; sustained exposure; tympanostomy tube.

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Conflict of interest statement

Declaration of Conflicting Interests: The author(s) declared the following potential conflicts of interest with respect to the research, authorship, and/or publication of this article: E.A.M. was the lead investigator on the trial, has received financial compensation for regulatory consultation from Otonomy, Inc, but not related to his role on this trial, and drafted multiple versions of the manuscript. J.R.M. was an investigator on the trial, provided technical guidance on the trial, and was involved in manuscript review. J.E.D. and P.J.A. were members of the data safety monitoring board and were financially compensated for time spent reviewing, discussing, interpreting patient safety data, and in manuscript review. M.B. is a paid consultant to Otonomy, Inc and was involved in the trial design, statistical analysis, and manuscript review. C.L. is currently an employee of Otonomy, Inc and was involved in the trial design, operation, and manuscript drafting and review.

Figures

Figure 1.
Figure 1.
Flow of patients through the trial.
Figure 2.
Figure 2.
Proportion of treatment failures through days 4 to 15. Treatment failure is defined as any otorrhea, otic, or systemic antibiotics or loss-to-follow-up. Cochran-Mantel-Haenszel exact test P values = 0.023(*) and 0.043(**) versus pooled placebo/sham.
Figure 3.
Figure 3.
Proportion of treatment failures by baseline culture status. (A) Baseline culture negative. (B) Baseline culture positive.
See this image and copyright information in PMC

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