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

Otonomy, Inc.39 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Acute Otitis Media AOMT

Interventions

OTO-201DRUG

Eligibility

Sex: ALLMin age: 6 MonthsMax age: 17 Years

Medical Language ↔ Plain English

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

Locations (5)

Central California Ear, Nose and Throat

Fresno, California, United States

South Florida Pediatric Otolaryngology

Fort Lauderdale, Florida, United States

Charlotte Eye, Ear, Nose and Throat Associates

Charlotte, North Carolina, United States

Charlotte Eye, Ear, Nose and Throat Associates

Matthews, North Carolina, United States

Outcomes

Primary Outcomes

Number of Ears With Otorrhea (Drainage From the Middle Ear)

Acute otitis media with tympanostomy tubes in place (AOMT) refers to subjects that have ear tubes present, but have a middle ear infection. Otorrhea is fluid drainage from the middle ear. This outcome is assessed during the otoscopic examination of each affected ear (the ear with the infection). All subjects have otorrhea in the affected ear at Baseline and the assessment is done after administering OTO-201 to be sure there is no infection remaining or no new infection.

Time frame: Day 29

Feasibility of Administration Questionnaire

Issues Administering OTO-201 onto the Tympanic Membrane and the Auditory Canal-facing Side of the Tympanostomy Tube (answered "yes")

Time frame: Day 1

Secondary Outcomes

Number of Ears With no More Otorrhea (Drainage From the Middle Ear)

Acute otitis media with tympanostomy tubes in place (AOMT) refers to subjects that have ear tubes present, but have a middle ear infection. Otorrhea is fluid drainage from the middle ear. This outcome is assessed during the otoscopic examination of each affected ear (the ear with the infection). All subjects have otorrhea in the affected ear at Baseline and the assessment is done 15 days after administering OTO-201 to see if it worked and there is no more drainage from the middle ear.

Time frame: Day 15

Data from ClinicalTrials.gov

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