Open-Label Study of OTO-201 in Pediatric Subjects With a History of Otitis Media Requiring Tympanostomy Tubes

Study Overview
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Brief Summary
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This is an 8-week, multicenter, open-label study in which eligible subjects with a history of otitis media requiring TT placement will receive 6 mg OTO-201 to each ear. The study is designed to evaluate the safety and efficacy of OTO-201 in subjects undergoing TT placement with common concurrent surgeries and any middle ear effusion status.

Official Title
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An 8-Week, Prospective, Multicenter, Open-Label Study of OTO-201 Given as a Single Administration in Pediatric Subjects With a History of Otitis Media Requiring Tympanostomy Tubes

Conditions
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Otitis Media

Intervention / Treatment
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* Drug: OTO-201 (ciprofloxacin)


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 history of otitis media requiring bilateral tympanostomy tube placement Subject's caregiver is willing to comply with the protocol and 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 TT placement Subject has been designated for any other surgical procedure that would occur concurrently with TT placement, except adenoidectomy, airway endoscopy, nasal endoscopy, and nasal cautery for epistaxis Subject has a history of sensorineural hearing loss

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: 0.1 mL OTO-201<br>Ciprofloxacin | Drug: OTO-201 (ciprofloxacin)<br> <br> * Other names: OTIPRIO;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Subjects With Post-surgical Otorrhea | Absence or presence of otorrhea (drainage from the middle ear) | Week 4 | 
| Number of Subjects With Post-surgical Otorrhea | Absence or presence of otorrhea (drainage from the middle ear) | 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse Events | Evaluation of adverse events | Up to Eight Weeks | 
| Caregiver Burden - Ear Discharge Control | Ear Drop Caregiver Burden Questionnaire at Week 4 | Week 4 | 
| Caregiver Burden - Ear Discharge Control | Ear Drop Caregiver Burden Questionnaire at Week 8 | Week 8 | 
| Caregiver Burden - Ear Drops Administration | Ear Drop Caregiver Burden Questionnaire at Week 8 | Week 8 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Ear infection, Otitis media, Tympanostomy tubes