Phase 3 Study of OTO-201 in Acute Otitis Externa

Otonomy, Inc.262 enrolled

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).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

262

Conditions

Acute Otitis Externa Swimmer's Ear

Interventions

12 mg ciprofloxacinDRUG

Single administration of OTO-201

Sham ControlDRUG

Simulated, single adminstration

Eligibility

Sex: ALLMin age: 6 Months

Medical Language ↔ Plain English

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

Locations (2)

Call Otonomy call center for trial locations

San Diego, California, United States

Call Otonomy call center for trial locations

Saskatoon, Canada

Outcomes

Primary Outcomes

Number of Subjects Considered a Clinical Cure at Day 8

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

Time frame: At Day 8 (1 week after dosing)

Secondary Outcomes

Number of Subjects Considered a Clinical Cure at Day 15

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

Time frame: At Day 15 (2 weeks after dosing)

Data from ClinicalTrials.gov

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