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