A 1-Month, Prospective, Multicenter, Open-Label Study of OTO-201 Given as a Single Trans-Tympanic Tube Administration for Intra-Operative Treatment of Middle Ear Effusion in Pediatric Subjects With Otitis Media Requiring Tympanostomy Tube Placement
Overview
- Phase
- Phase 3
- Intervention
- OTO-201
- Conditions
- Bilateral Middle Ear Effusion
- Sponsor
- Otonomy, Inc.
- Enrollment
- 33
- Locations
- 4
- Primary Endpoint
- Otoscopic Examination: Auricle and Meatus
- Status
- Completed
- Last Updated
- 5 years ago
Overview
Brief Summary
This is a 1-month, prospective, multicenter, open-label study in pediatric subjects with bilateral middle ear effusion requiring tympanostomy tube placement. Eligible subjects will receive a single dose to each ear of 6 mg OTO-201, administered intraoperatively into the middle ear through the lumen of the tympanostomy tube (trans-tympanostomy tube TTT). The study is designed to characterize safety and any procedural issues associated with TTT drug administration of OTO-201.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
OTO-201
6 mg OTO-201 administered trans-tympanostomy tube
Intervention: OTO-201
Outcomes
Primary Outcomes
Otoscopic Examination: Auricle and Meatus
Time Frame: Up to 1 month
Number of ears whose external ear and ear canal (auricle and meatus), when examined through an otoscope, appeared normal at Baseline and appeared abnormal at Day 29
Otoscopic Examination: Tympanic Membrane
Time Frame: up to 1 month
Number of ears whose ear drum (tympanic membrane), when examined through an otoscope, appeared normal at Baseline and appeared abnormal at Day 29
Otoscopic Examination: Tube Patency
Time Frame: Up to 1 month
Subjects with at least one ear tube patent (i.e., not blocked) at Day 29
Secondary Outcomes
- Feasibility of Administration(Day 1)