Open-Label Study of OTO-201 for Treatment of AOMT

Status:	Completed
Conditions:	Other Indications, Infectious Disease, Infectious Disease
Therapuetic Areas:	Immunology / Infectious Diseases, Other
Healthy:	No
Age Range:	Any - 17
Updated:	4/13/2015
Start Date:	March 2015
End Date:	June 2015
Contact:	JoAnn Dyangko
Email:	jdyangko@otonomy.com

A 1-Month, Prospective, Multicenter, Open-Label Study of OTO-201 Given as a Single Supra-Tympanostomy Tube Administration for Treatment of Acute Otitis Media With Tympanostomy Tubes in Pediatric Subjects

This is a 1-month, prospective, multicenter, open-label study in pediatric subjects with
either unilateral or bilateral acute otitis media with tympanostomy tubes (AOMT). Eligible
subjects will receive a single dose of 6 mg OTO-201 to the affected ear(s). The study is
designed to characterize safety, procedural factors and clinical effect of OTO-201
administered in subjects with AOMT.

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

We found this trial at

sites

Charlotte Eye, Ear, Nose & Throat Associates

Charlotte, North Carolina 28210

from

Charlotte, NC