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

• Status: Completed
• Trial end date: 2013-06-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to describe the safety and tolerability of two dose levels of OTO-201, placebo and sham when administered intra-operatively in pediatric subjects with bilateral middle ear effusion who require tympanostomy tube placement.

• Phase: Phase 1
• 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 12 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