OTO-201 for the Treatment of Otitis Externa

Study Overview
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Brief Summary
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This is a 1-month, multicenter, open-label study in subjects with unilateral otitis externa. Eligible subjects will receive a single dose of 6 mg OTO-201 to the affected ear. The study is designed to characterize safety, procedural factors and clinical effect of OTO-201 administered in subjects with otitis externa.

Official Title
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A 1-Month, Prospective, Multicenter, Open-Label Study of OTO-201 Given as a Single Administration for Treatment of Otitis Externa

Conditions
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Otitis Externa

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 80 years, inclusive Subject has a clinical diagnosis of unilateral otitis externa Subject or 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 tympanic membrane perforation Subject has a history of known immunodeficiency disease Subject has fungal otitis externa, based on clinical signs

Ages Eligible for Study
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Minimum Age: 6 Months
Maximum Age: 80 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: 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> |
| Experimental: 0.2 mL OTO-201<br>Ciprofloxacin | Drug: OTO-201 (ciprofloxacin)<br> <br> |
| Experimental: 0.4 mL OTO-201<br>Ciprofloxacin | Drug: OTO-201 (ciprofloxacin)<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Otoscopic Examination: Tympanic Membrane | Number of subjects with a tympanic membrane that was rated as Not able to Visualize or Abnormal at Baseline that was rated as Normal at Day 29 (final study day) | Up to 1 month | 
| Otoscopic Examination: Middle Ear | Number of subjects with a middle ear that was rated as Not Able to Visualize or Abnormal at Baseline that had a middle ear rated as Normal at Day 29 (final study visit) | Up to 1 month | 
| Feasibility of Administration | Ease of administering OTO-201 to the external ear canal. Number of subjects that investigators rated ease of administration as either easy or very easy. | Day1 | 
| Overall Adverse Events | Number of Subjects with and without adverse events during the study from dosing up to 1 month after dosing | up to 1 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Subjects Considered a Clinical Cure at Day 15 (Intent-to-treat Analysis Set) | Clinical Signs (edema, erythema, otorrhea and otalgia) all had a score of 0 at Day 15. Each sign was graded as follows: None = 0 Mild = 1 Moderate = 2 Severe = 3 | Day 15 (two weeks from dosing) | 
| Number of Subjects Considered a Clinical Cure at Day 15 (Per-protocol Analysis Set) | Clinical Signs (edema, erythema, otorrhea and otalgia) all had a score of 0 at Day 15. Each sign was graded as follows: None = 0 Mild = 1 Moderate = 2 Severe = 3 | Day 15 (2 weeks from dosing) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Otitis externa, Swimmer's ear, Ear infection