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

Overview

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.

Full Title of Study: “Prospective, Randomized, Double-Blind, Sham-Controlled, Multicenter, P3 Study of OTO-201 Given as a Single IT Injection For Intra-Operative Treatment of Middle Ear Effusion in Pediatric Subjects Requiring Tympanostomy Tube Placement”

Study Type

• Study Type: Interventional
• Study Design
  • Allocation: Randomized
  • Intervention Model: Parallel Assignment
  • Primary Purpose: Treatment
  • Masking: Triple (Participant, Care Provider, Outcomes Assessor)
• Study Primary Completion Date: May 2014

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.

Interventions

• Drug: OTO-201
  • Single, intratympanic injection
• Drug: Sham
  • Simulated single, intratympanic injection

Arms, Groups and Cohorts

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

Clinical Trial Outcome Measures

Primary Measures

• Percentage of Participants Who Were Treatment Failures
  • Time Frame: 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 Measures

• Evaluation of Adverse Events, Otoscopic Exams, Audiometry, and Tympanometry
  • Time Frame: Up to one month
  • Safety variables included the frequency of adverse events (AEs) and results from otoscopic examinations, tympanometry, audiometry, vital sign measurements, and physical examinations.
• Microbiological Response
  • Time Frame: Day 15 – 2 weeks after dosing
  • Subjects whose samples tested positive for bacteria in either or both ears.

Participating in This Clinical Trial

Inclusion Criteria includes, but is not limited to:

• Subject is a male or female aged 6 months to 17 years, inclusive – Subject has a clinical diagnosis of bilateral middle ear effusion requiring tympanostomy tube placement – Subject's caregiver is willing to comply with the protocol and attend all study visits Exclusion Criteria includes, but is not limited to: – Subject has a history of prior ear or mastoid surgery, not including myringotomy or myringotomy with tympanostomy tube placement – Subject has a history of sensorineural hearing loss – Subject has a history of chronic or recurrent bacterial infections other than otitis media that likely will require treatment with antibiotics during the course of the study

Gender Eligibility: All

Minimum Age: 6 Months

Maximum Age: 17 Years

Are Healthy Volunteers Accepted: No

Investigator Details

• Lead Sponsor
  • Otonomy, Inc.
• Provider of Information About this Clinical Study
  • Sponsor
• Overall Official(s)
  • Carl LeBel, PhD, Study Director, Otonomy, Inc.