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
Overview
- Phase
- Phase 2
- Intervention
- OTO-201
- Conditions
- Acute Otitis Media
- Sponsor
- Otonomy, Inc.
- Enrollment
- 39
- Locations
- 4
- Primary Endpoint
- Feasibility of Administration Questionnaire
- Status
- Completed
- Last Updated
- 5 years ago
Overview
Brief 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.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
OTO-201
6 mg OTO-201
Intervention: OTO-201
Outcomes
Primary Outcomes
Feasibility of Administration Questionnaire
Time Frame: Day 1
Issues Administering OTO-201 onto the Tympanic Membrane and the Auditory Canal-facing Side of the Tympanostomy Tube (answered "yes")
Number of Ears With Otorrhea (Drainage From the Middle Ear)
Time Frame: Day 29
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.
Secondary Outcomes
- Number of Ears With no More Otorrhea (Drainage From the Middle Ear)(Day 15)