Open-Label Study of OTO-201 for Treatment of AOMT

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.

Timeline

Start

2015-03

Primary completion

2015-05

Completion

2015-05

Drugs

Indications