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Phase 3 Study of OTO-201 in Acute Otitis Externa

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02801370
Recruitment Status : Completed
First Posted : June 15, 2016
Last Update Posted : May 25, 2017
Information provided by (Responsible Party):
Otonomy, Inc.

Brief Summary:
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).

Condition or disease Intervention/treatment Phase
Acute Otitis Externa Swimmer's Ear Drug: 12 mg ciprofloxacin Drug: Sham Control Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 262 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : June 2016
Actual Primary Completion Date : November 2016
Actual Study Completion Date : December 2016

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: OTO-201 Drug: 12 mg ciprofloxacin
Single administration of OTO-201
Other Name: OTIPRIO

Sham Comparator: Control Drug: Sham Control
Simulated, single adminstration

Primary Outcome Measures :
  1. Clinical cure assessed by otoscopic examination [ Time Frame: Up to Day 8 ]

Secondary Outcome Measures :
  1. Safety as assessed by adverse events [ Time Frame: Up to 1 month ]
    Evaluation of adverse events

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   6 Months and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02801370

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United States, California
Call Otonomy call center for trial locations
San Diego, California, United States, 92121
Call Otonomy call center for trial locations
Saskatoon, Canada
Sponsors and Collaborators
Otonomy, Inc.
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Study Chair: Carl LeBel, PhD Otonomy, Inc.
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Responsible Party: Otonomy, Inc. Identifier: NCT02801370    
Other Study ID Numbers: 201-201609
First Posted: June 15, 2016    Key Record Dates
Last Update Posted: May 25, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Otitis Externa
Ear Diseases
Otorhinolaryngologic Diseases
Anti-Bacterial Agents
Anti-Infective Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Cytochrome P-450 CYP1A2 Inhibitors
Cytochrome P-450 Enzyme Inhibitors