Dose Ranging Study of OTO-201 in AOMT

• Status: Completed
• Trial end date: 2016-07-01
• Target enrollment: 0
• Participant gender: All

Summary

Dose Ranging Study of OTO-201 in AOMT

• 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 17 years, inclusive

• Subject has a clinical diagnosis of acute otitis media with tympanostomy tubes (AOMT)

• Subject's caregiver is willing to comply with the protocol an attend all study visits

Exclusion Criteria includes, but is not limited to:

• Subject has a history of sensorineural hearing loss

• Subject has tympanic membrane perforation other than the surgical tympanostomy tube perforation

• Subject has a history of known immunodeficiency disease