Open-Label Study of OTO-201 for Middle Ear Effusion Evaluating Trans-Tympanostomy Tube Administration

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 bilateral middle ear effusion requiring tympanostomy tube placement. Eligible subjects will receive a single dose to each ear of 6 mg OTO-201, administered intraoperatively into the middle ear through the lumen of the tympanostomy tube (trans-tympanostomy tube TTT). The study is designed to characterize safety and any procedural issues associated with TTT drug administration of OTO-201.

Official Title
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A 1-Month, Prospective, Multicenter, Open-Label Study of OTO-201 Given as a Single Trans-Tympanic Tube Administration for Intra-Operative Treatment of Middle Ear Effusion in Pediatric Subjects With Otitis Media Requiring Tympanostomy Tube Placement

Conditions
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Bilateral Middle Ear Effusion

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 bilateral middle ear effusion requiring tympanostomy tube placement 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 prior ear or mastoid surgery, not including myringotomy or myringotomy with tympanostomy tube placement Subject has a history of sensorineural hearing loss Subject has been designated for any other surgical procedure that would occur concurrently with TT placement, such as, but not limited to adenoidectomy or tonsillectomy

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 administered trans-tympanostomy tube | Drug: OTO-201<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Otoscopic Examination: Auricle and Meatus | Number of ears whose external ear and ear canal (auricle and meatus), when examined through an otoscope, appeared normal at Baseline and appeared abnormal at Day 29 | Up to 1 month | 
| Otoscopic Examination: Tympanic Membrane | Number of ears whose ear drum (tympanic membrane), when examined through an otoscope, appeared normal at Baseline and appeared abnormal at Day 29 | up to 1 month | 
| Otoscopic Examination: Tube Patency | Subjects with at least one ear tube patent (i.e., not blocked) at Day 29 | Up to 1 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Feasibility of Administration | Ease of administering OTO-201 through the tympanostomy tube: Number of subjects that investigators rated ease of administration as either easy or very easy | Day 1 |