OTO-201 for the Treatment of Middle Ear Effusion in Pediatric Subjects Requiring Tympanostomy Tube Placement

Phase 3

Completed

Brief Summary: The purpose of this study is to confirm the effectiveness, safety and tolerability of OTO-201 in the treatment of pediatric subjects with bilateral middle ear effusion who require tympanostomy tube placement.

Detailed Description: This is a prospective, randomized, double-blind, sham-controlled, multicenter, Phase 3 study of OTO-201 administered intraoperatively in pediatric subjects with bilateral middle ear effusion requiring TT (tympanostomy tube) placement. One dose level (6 mg) of OTO-201 was evaluated relative to sham (empty syringe).

Study subjects are required to have a clinical diagnosis of bilateral middle ear effusion requiring TT placement. On the day of surgery, prior to surgery, eligible subjects were examined via otoscope to confirm bilateral middle ear effusion. Subjects with bilateral middle ear effusion were randomized to either 6 mg OTO-201 or sham. Subjects without bilateral effusion on the day of surgery were not randomized and were considered screen failures.

Approximately 264 subjects are planned to be randomized to OTO-201 or sham using a 2:1 allocation ratio. Randomization to OTO-201 or sham was stratified by age: 6 months to 2 years or \>2 years.

Subjects are to visit the study site for safety assessments and otoscopic examination on Days 4, 8, 15, and 29. The assessment of otorrhea by the blinded assessor for the primary efficacy endpoint occurred on Days 4, 8, and 15.

Recruitment & Eligibility

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Arm && Interventions

Group	Intervention	Description
OTO-201	OTO-201	OTO-201: Single, intratympanic injection: One injection of 6 mg OTO-201 (ciprofloxacin in poloxamer 407) into each ear during surgery.
Sham	Sham	Sham: Simulated single, intratympanic injection: One sham injection into each ear during surgery.

Primary Outcome Measures

Name	Time	Method
Percentage of Participants Who Were Treatment Failures.	Day 15 - 2 weeks after dosing	Cumulative proportion of treatment failures: The efficacy endpoint for both trials was the cumulative proportion of study treatment failures through Day 15, defined as the occurrence of any of the following events: otorrhea as determined by a blinded assessor on or after 3 days post-surgery, otic or systemic antibacterial drug use for any reason any time post-surgery, as well as patients who missed visits or were lost-to-follow-up.

Secondary Outcome Measures

Name	Time	Method
Evaluation of Adverse Events, Otoscopic Exams, Audiometry and Tympanometry	Up to one month	Safety variables included the frequency of adverse events (AEs) and results from otoscopic examinations, tympanometry, audiometry measurements.
Microbiological Response	Day 15 - 2 weeks after dosing	Subjects whose samples tested positive for bacteria in either or both ears at baseline with documented eradication or presumed eradication post-baseline.