OTO-201 for the Treatment of Otitis Externa

• Status: Completed
• Trial end date: 2015-11-01
• Target enrollment: 0
• Participant gender: All

Summary

This is a 1-month, multicenter, open-label study in subjects with unilateral otitis externa. Eligible subjects will receive a single dose of 6 mg OTO-201 to the affected ear. The study is designed to characterize safety, procedural factors and clinical effect of OTO-201 administered in subjects with otitis externa.

• Phase: Phase 2
• 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 aged 6 months to 80 years, inclusive

• Subject has a clinical diagnosis of unilateral 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 a history of known immunodeficiency disease

• Subject has fungal otitis externa, based on clinical signs