Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

OTO-201 for the Treatment of 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.
 
ClinicalTrials.gov Identifier: NCT02511561
Recruitment Status : Completed
First Posted : July 30, 2015
Results First Posted : September 22, 2020
Last Update Posted : October 19, 2020
Sponsor:
Information provided by (Responsible Party):
Otonomy, Inc.

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Otitis Externa Drug: OTO-201 (ciprofloxacin) Phase 2

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 75 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A 1-Month, Prospective, Multicenter, Open-Label Study of OTO-201 Given as a Single Administration for Treatment of Otitis Externa
Study Start Date : July 2015
Actual Primary Completion Date : November 2015
Actual Study Completion Date : November 2015

Resource links provided by the National Library of Medicine


Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Experimental: 0.1 mL OTO-201
Ciprofloxacin
 Drug: OTO-201 (ciprofloxacin)
Experimental: 0.2 mL OTO-201
Ciprofloxacin
 Drug: OTO-201 (ciprofloxacin)
Experimental: 0.4 mL OTO-201
Ciprofloxacin
 Drug: OTO-201 (ciprofloxacin)


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Otoscopic Examination: Tympanic Membrane [ Time Frame: Up to 1 month ]
    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)

  2. Otoscopic Examination: Middle Ear [ Time Frame: Up to 1 month ]
    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)

  3. Feasibility of Administration [ Time Frame: Day1 ]
    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".

  4. Overall Adverse Events [ Time Frame: up to 1 month ]
    Number of Subjects with and without adverse events during the study from dosing up to 1 month after dosing


Secondary Outcome Measures :
  1. Number of Subjects Considered a Clinical Cure at Day 15 (Intent-to-treat Analysis Set) [ Time Frame: Day 15 (two weeks from 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


  2. Number of Subjects Considered a Clinical Cure at Day 15 (Per-protocol Analysis Set) [ Time Frame: Day 15 (2 weeks from 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



Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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.


Layout table for eligibility information
Ages Eligible for Study:   6 Months to 80 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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 ClinicalTrials.gov identifier (NCT number): NCT02511561


Locations
Layout table for location information
United States, California
Email Otonomy Central Contact for Trial Locations
San Diego, California, United States, 92121
Sponsors and Collaborators
Otonomy, Inc.
Investigators
Layout table for investigator information
Study Chair: Carl LeBel, PhD Otonomy, Inc.
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Otonomy, Inc.
ClinicalTrials.gov Identifier: NCT02511561    
Other Study ID Numbers: 201-201506
First Posted: July 30, 2015    Key Record Dates
Results First Posted: September 22, 2020
Last Update Posted: October 19, 2020
Last Verified: September 2020
Keywords provided by Otonomy, Inc.:
Otitis externa
Swimmer's ear
Ear infection
Additional relevant MeSH terms:
Layout table for MeSH terms
Otitis
Otitis Externa
Ear Diseases
Otorhinolaryngologic Diseases
Ciprofloxacin
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