Dose Ranging Study of OTO-201 in AOMT

A 1-Month, Prospective, Multicenter, Randomized, Dose-Ranging, Sham-Controlled, Blinded Study of OTO-201 Given as a Single Administration for Treatment of Acute Otitis Media With Tympanostomy Tubes in Pediatric Subjects

Dose Ranging Study of OTO-201 in AOMT

This is a 1-month, prospective, multicenter, randomized, dose-ranging, sham-controlled, blinded study in which eligible subjects with either unilateral or bilateral acute otitis media with tympanostomy tubes (AOMT) will receive a single administration of 6 mg OTO-201, 12 mg OTO-201, or sham into the affected ear(s).

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