Phase 3 Study of OTO-201 in Acute Otitis Externa

Summary

This is a prospective, randomized, double-blind, sham-controlled, multicenter, Phase 3 study in which eligible subjects with acute otitis externa (AOE) will be randomized to receive a single administration of either 12 mg OTO-201 or Sham-Control (empty syringe) to the external auditory canal of the affected ear(s).

Timeline

Start

2016-06

Primary completion

2016-11

Completion

2016-12

Drugs

Indications