Phase 3 Study of OTO-201 in Acute Otitis Externa

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

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 Overview

• Status: Completed
• Conditions: Acute Otitis Externa; Swimmer's Ear
• Intervention / Treatment: Drug: 12 mg ciprofloxacin; Drug: Sham Control

• Study Type: Interventional
• Enrollment (Actual): 262
• Phase: Phase 3

Contacts and Locations

Study Locations

• Canada
  • Saskatoon, Canada
    • Call Otonomy call center for trial locations
• United States
  • California
    • San Diego, California, United States, 92121
      • Call Otonomy call center for trial locations

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 months and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Sham Comparator: Control	Drug: Sham Control; Simulated, single adminstration
Experimental: OTO-201	Drug: 12 mg ciprofloxacin; Single administration of OTO-201; Other Names: OTIPRIO

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	At Day 8 (1 week after dosing)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	At Day 15 (2 weeks after dosing)

Collaborators and Investigators

• Sponsor: Otonomy, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2016
• Primary Completion (Actual): November 1, 2016
• Study Completion (Actual): December 1, 2016

Study Registration Dates

• First Submitted: June 13, 2016
• First Submitted That Met QC Criteria: June 13, 2016
• First Posted (Estimate): June 15, 2016

Study Record Updates

• Last Update Posted (Actual): October 19, 2020
• Last Update Submitted That Met QC Criteria: September 21, 2020
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Otorhinolaryngologic Diseases; Ear Diseases; Otitis Externa; Otitis; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Enzyme Inhibitors; Antineoplastic Agents; Topoisomerase II Inhibitors; Topoisomerase Inhibitors; Anti-Bacterial Agents; Cytochrome P-450 Enzyme Inhibitors; Cytochrome P-450 CYP1A2 Inhibitors; Ciprofloxacin
• Other Study ID Numbers: 201-201609

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO