Open-Label Study of OTO-201 for Middle Ear Effusion Evaluating Trans-Tympanostomy Tube Administration
Completed · Phase 3
Conditions studied: Bilateral Middle Ear Effusion
In brief
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.
Key facts
- Study ID
- NCT02350998
- Run by
- Otonomy, Inc.
- People needed
- 33
- Starts
- 2015-01-01
- Expected to finish
- 2015-03-01
- Last updated by the study team
- 2020-10-19
Who can join
Age: 1 and older, up to 17. Sex: any. Healthy volunteers: not accepted.
Where it is running
- Central California Ear, Nose and Throat — Fresno, California, United States
- Charlotte Eye, Ear, Nose and Throat Associates — Charlotte, North Carolina, United States
- Charlotte Eye, Ear, Nose and Throat Associates — Matthews, North Carolina, United States
- Piedmont Ear, Nose and Throat — Winston-Salem, North Carolina, United States
- Carolina Ear, Nose and Throat — Orangeburg, South Carolina, United States
Full record on ClinicalTrials.gov
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