Overview

OTO-201 for the Treatment of Middle Ear Effusion in Pediatric Subjects Requiring Tympanostomy Tube Placement

Status:
Completed
Trial end date:
2014-05-01
Target enrollment:
0
Participant gender:
All
Summary
The purpose of this study is to confirm the effectiveness, safety and tolerability of OTO-201 in the treatment of pediatric subjects with bilateral middle ear effusion who require tympanostomy tube placement.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Otonomy, Inc.
Criteria
Inclusion Criteria includes, but is not limited to:

- Subject is a male or female aged 6 months to 17 years, inclusive

- Subject has a clinical diagnosis of bilateral middle ear effusion requiring
tympanostomy tube placement

- 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 a history of prior ear or mastoid surgery, not including myringotomy or
myringotomy with tympanostomy tube placement

- Subject has a history of sensorineural hearing loss

- Subject has a history of chronic or recurrent bacterial infections other than otitis
media that likely will require treatment with antibiotics during the course of the
study