Phase 3 Study of OTO-201 in Acute Otitis Externa
Overview
This is a prospective, randomized, double-blind, sham-controlled, multicenter, Phase 3 study in which eligible subjects with acute otitis externa (AOE) will be randomized to receive a single administration of either 12 mg OTO-201 or Sham-Control (empty syringe) to the external auditory canal of the affected ear(s).
Full Title of Study: “A Prospective, Randomized, Double-Blind, Sham-Controlled, Multicenter, Phase 3 Study of OTO-201 Given as a Single Administration for Treatment of Acute Otitis Externa”
Study Type
- Study Type: Interventional
- Study Design
- Allocation: Randomized
- Intervention Model: Single Group Assignment
- Primary Purpose: Treatment
- Masking: Triple (Participant, Care Provider, Investigator)
- Study Primary Completion Date: November 2016
Interventions
- Drug: 12 mg ciprofloxacin
- Single administration of OTO-201
- Drug: Sham Control
- Simulated, single adminstration
Arms, Groups and Cohorts
- Experimental: OTO-201
- Sham Comparator: Control
Clinical Trial Outcome Measures
Primary Measures
- Number of Subjects Considered a Clinical Cure at Day 8
- Time Frame: At Day 8 (1 week after dosing)
- 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
Secondary Measures
- Number of Subjects Considered a Clinical Cure at Day 15
- Time Frame: At Day 15 (2 weeks after dosing)
- 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
Participating in This Clinical Trial
Inclusion Criteria includes, but is not limited to:
- Subject is a male or female age 6 months or older – Subject has a clinical diagnosis of unilateral or bilateral acute 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 eczematoid otitis externa – Subject has diabetes mellitus
Gender Eligibility: All
Minimum Age: 6 Months
Maximum Age: N/A
Are Healthy Volunteers Accepted: No
Investigator Details
- Lead Sponsor
- Otonomy, Inc.
- Provider of Information About this Clinical Study
- Sponsor
- Overall Official(s)
- Carl LeBel, PhD, Study Chair, Otonomy, Inc.
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