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

Acute Otitis Media Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02408796
• Other study ID #: 201-201505
• Status: Completed
• Phase: Phase 2
• Start date: March 2015
• Est. completion date: May 2015

Study information

• Verified date: September 2020
• Source: Otonomy, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 39
• Est. completion date: May 2015
• Est. primary completion date: May 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Months to 17 Years

Eligibility

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

Related Conditions & MeSH terms

• Acute Otitis Media
• AOMT
• Otitis
• Otitis Media

Intervention

Drug:
• OTO-201

Locations

Country	Name	City	State
United States	Charlotte Eye, Ear, Nose and Throat Associates	Charlotte	North Carolina
United States	South Florida Pediatric Otolaryngology	Fort Lauderdale	Florida
United States	Central California Ear, Nose and Throat	Fresno	California
United States	Charlotte Eye, Ear, Nose and Throat Associates	Matthews	North Carolina
United States	Carolina Ear, Nose and Throat	Orangeburg	South Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Otonomy, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Day 29
Primary	Feasibility of Administration Questionnaire	Issues Administering OTO-201 onto the Tympanic Membrane and the Auditory Canal-facing Side of the Tympanostomy Tube (answered "yes")	Day 1
Secondary	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.	Day 15