Dose Ranging Study of OTO-201 in AOMT

Study Overview
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Brief Summary
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Dose Ranging Study of OTO-201 in AOMT

Detailed Description
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This is a 1-month, prospective, multicenter, randomized, dose-ranging, sham-controlled, blinded study in which eligible subjects with either unilateral or bilateral acute otitis media with tympanostomy tubes (AOMT) will receive a single administration of 6 mg OTO-201, 12 mg OTO-201, or sham into the affected ear(s).

Official Title
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A 1-Month, Prospective, Multicenter, Randomized, Dose-Ranging, Sham-Controlled, Blinded Study of OTO-201 Given as a Single 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: 6 mg ciprofloxacin
* Drug: 12 mg ciprofloxacin
* Other: Sham


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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 6 mg OTO-201<br>6 mg OTO-201 (sustained-release suspension of ciprofloxacin), single 0.1 mL supra-tympanostomy tube (STT) administration to the affected ear(s) | Drug: 6 mg ciprofloxacin<br>* Single administration of OTO-201<br>* Other names: OTIPRIO;|
| Experimental: 12 mg OTO-201<br>12 mg OTO-201 (sustained-release suspension of ciprofloxacin), single 0.2 mL supra-tympanostomy tube (STT) administration to the affected ear(s) | Drug: 12 mg ciprofloxacin<br>* Single administration of OTO-201<br>* Other names: OTIPRIO;|
| Sham Comparator: Sham (empty syringe)<br>Sham (empty syringe), single 0.1 mL STT administration to the affected ear(s) | Other: Sham<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Subjects With Adverse Events | Number of subjects with adverse events during the study from dosing up to 1 month after dosing | Up to 1 month | 
| Otoscopic Examination: Auricle and Meatus | Number of affected ears (i.e., those ears that were infected) whose external ear and ear canal (auricle and meatus), when examined through an otoscope, appeared normal at Baseline and appeared abnormal at Day 29. The auricle and meatus of each infected ear was examined using an otoscope and was assessed as either normal or abnormal at every visit. This outcome looks to see if there was a worsening of the condition of the auricle and meatus with treatment (i.e., a safety measure). | Up to 1 month | 
| Otoscopic Examination: Tympanic Membrane | Number of affected ears (i.e., those ears that were infected) whose ear drum (tympanic membrane), when examined through an otoscope, appeared normal at Baseline and appeared abnormal at Day 29. The tympanic membrane of each infected ear was examined using an otoscope and was assessed as either normal or abnormal at every visit. This outcome looks to see if there was a worsening of the condition of the tympanic membrane with treatment (i.e., a safety measure). | Up to 1 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Absence of Otorrhea | Absence of otorrhea (middle ear drainage) | Up to Two Weeks | 

 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, OTIPRIO