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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Acute Otitis Media, AOMT

Intervention / Treatment
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* Drug: OTO-201


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 6 Months
Maximum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: OTO-201<br>6 mg OTO-201 | Drug: OTO-201<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Acute otitis media with tympanostomy tubes