Conditions: Bilateral Middle Ear Effusion
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 33
Healthy volunteers: no

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.

Detailed description:

Arms:
arm 1: 6 mg OTO-201 administered trans-tympanostomy tube

Interventions: intervention 1: OTO-201
Intervention descriptions: intervention 1: None

Protocol document: