Overview

Phase 3 Study of OTO-201 in Acute Otitis Externa

Status:
Completed
Trial end date:
2016-12-01
Target enrollment:
0
Participant gender:
All
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).
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Otonomy, Inc.
Treatments:
Ciprofloxacin
Criteria
Inclusion Criteria includes, but is not limited to:

- Subject is a male or female age 6 months or older

- Subject has a clinical diagnosis of unilateral or bilateral acute otitis externa

- Subject or subject's caregiver is willing to comply with the protocol and attend all
study visits

Exclusion Criteria includes, but is not limited to:

- Subject has tympanic membrane perforation

- Subject has eczematoid otitis externa

- Subject has diabetes mellitus