Conditions: Acute Otitis Media AOMT
Keywords: Acute otitis media with tympanostomy tubes
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 39
Healthy volunteers: no

Brief summary:
This is a 1-month, prospective, multicenter, open-label study in pediatric subjects with either unilateral or bilateral acute otitis media with tympanostomy tubes (AOMT). Eligible subjects will receive a single dose of 6 mg OTO-201 to the affected ear(s). The study is designed to characterize safety, procedural factors and clinical effect of OTO-201 administered in subjects with AOMT.

Detailed description:

Arms:
arm 1: 6 mg OTO-201

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

Protocol document: