Back to resultsOTO-201 for the Treatment of Otitis Externa
Primary Purpose
Otitis Externa
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
OTO-201 (ciprofloxacin)
Sponsored by
About this trial
This is an interventional treatment trial for Otitis Externa focused on measuring Otitis externa, Swimmer's ear, Ear infection
Eligibility 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
Sites / Locations
- Email Otonomy Central Contact for Trial Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
0.1 mL OTO-201
0.2 mL OTO-201
0.4 mL OTO-201
Arm Description
Ciprofloxacin
Ciprofloxacin
Ciprofloxacin
Outcomes
Primary Outcome Measures
Otoscopic Examination: Tympanic Membrane
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)
Otoscopic Examination: Middle Ear
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)
Feasibility of Administration
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".
Overall Adverse Events
Number of Subjects with and without adverse events during the study from dosing up to 1 month after dosing
Secondary Outcome Measures
Number of Subjects Considered a Clinical Cure at Day 15 (Intent-to-treat Analysis Set)
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
Number of Subjects Considered a Clinical Cure at Day 15 (Per-protocol Analysis Set)
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02511561
Brief Title
OTO-201 for the Treatment of Otitis Externa
Official Title
A 1-Month, Prospective, Multicenter, Open-Label Study of OTO-201 Given as a Single Administration for Treatment of Otitis Externa
Study Type
Interventional
2. Study Status
Record Verification Date
September 2020
Overall Recruitment Status
Completed
Study Start Date
July 2015 (undefined)
Primary Completion Date
November 2015 (Actual)
Study Completion Date
November 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Otonomy, Inc.
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Otitis Externa
Keywords
Otitis externa, Swimmer's ear, Ear infection
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
75 (Actual)
8. Arms, Groups, and Interventions
Arm Title
0.1 mL OTO-201
Arm Type
Experimental
Arm Description
Ciprofloxacin
Arm Title
0.2 mL OTO-201
Arm Type
Experimental
Arm Description
Ciprofloxacin
Arm Title
0.4 mL OTO-201
Arm Type
Experimental
Arm Description
Ciprofloxacin
Intervention Type
Drug
Intervention Name(s)
OTO-201 (ciprofloxacin)
Primary Outcome Measure Information:
Title
Otoscopic Examination: Tympanic Membrane
Description
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)
Time Frame
Up to 1 month
Title
Otoscopic Examination: Middle Ear
Description
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)
Time Frame
Up to 1 month
Title
Feasibility of Administration
Description
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".
Time Frame
Day1
Title
Overall Adverse Events
Description
Number of Subjects with and without adverse events during the study from dosing up to 1 month after dosing
Time Frame
up to 1 month
Secondary Outcome Measure Information:
Title
Number of Subjects Considered a Clinical Cure at Day 15 (Intent-to-treat Analysis Set)
Description
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
Day 15 (two weeks from dosing)
Title
Number of Subjects Considered a Clinical Cure at Day 15 (Per-protocol Analysis Set)
Description
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
Day 15 (2 weeks from dosing)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Months
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Carl LeBel, PhD
Organizational Affiliation
Otonomy, Inc.
Official's Role
Study Chair
Facility Information:
Facility Name
Email Otonomy Central Contact for Trial Locations
City
San Diego
State/Province
California
ZIP/Postal Code
92121
Country
United States
12. IPD Sharing Statement
Learn more about this trial
OTO-201 for the Treatment of Otitis Externa
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