Back to resultsOpen-Label Study of OTO-201 for Middle Ear Effusion Evaluating Trans-Tympanostomy Tube Administration
Primary Purpose
Bilateral Middle Ear Effusion
Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
OTO-201
Sponsored by
About this trial
This is an interventional treatment trial for Bilateral Middle Ear Effusion
Eligibility Criteria
Inclusion Criteria includes, but is not limited to:
- Subject is a male or female aged 6 months to 17 years, inclusive
- Subject has a clinical diagnosis of bilateral middle ear effusion requiring tympanostomy tube placement
- Subject's caregiver is willing to comply with the protocol an attend all study visits
Exclusion Criteria includes, but is not limited to:
- Subject has a history of prior ear or mastoid surgery, not including myringotomy or myringotomy with tympanostomy tube placement
- Subject has a history of sensorineural hearing loss
- Subject has been designated for any other surgical procedure that would occur concurrently with TT placement, such as, but not limited to adenoidectomy or tonsillectomy
Sites / Locations
- Central California Ear, Nose and Throat
- Charlotte Eye, Ear, Nose and Throat Associates
- Charlotte Eye, Ear, Nose and Throat Associates
- Piedmont Ear, Nose and Throat
- Carolina Ear, Nose and Throat
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
OTO-201
Arm Description
6 mg OTO-201 administered trans-tympanostomy tube
Outcomes
Primary Outcome Measures
Otoscopic Examination: Auricle and Meatus
Number of ears whose external ear and ear canal (auricle and meatus), when examined through an otoscope, appeared normal at Baseline and appeared abnormal at Day 29
Otoscopic Examination: Tympanic Membrane
Number of ears whose ear drum (tympanic membrane), when examined through an otoscope, appeared normal at Baseline and appeared abnormal at Day 29
Otoscopic Examination: Tube Patency
Subjects with at least one ear tube patent (i.e., not blocked) at Day 29
Secondary Outcome Measures
Feasibility of Administration
Ease of administering OTO-201 through the tympanostomy tube: Number of subjects that investigators rated ease of administration as either "easy" or "very easy"
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02350998
Brief Title
Open-Label Study of OTO-201 for Middle Ear Effusion Evaluating Trans-Tympanostomy Tube Administration
Official Title
A 1-Month, Prospective, Multicenter, Open-Label Study of OTO-201 Given as a Single Trans-Tympanic Tube Administration for Intra-Operative Treatment of Middle Ear Effusion in Pediatric Subjects With Otitis Media Requiring Tympanostomy Tube Placement
Study Type
Interventional
2. Study Status
Record Verification Date
September 2020
Overall Recruitment Status
Completed
Study Start Date
January 2015 (undefined)
Primary Completion Date
March 2015 (Actual)
Study Completion Date
March 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, prospective, multicenter, open-label study in pediatric subjects with bilateral middle ear effusion requiring tympanostomy tube placement. Eligible subjects will receive a single dose to each ear of 6 mg OTO-201, administered intraoperatively into the middle ear through the lumen of the tympanostomy tube (trans-tympanostomy tube TTT). The study is designed to characterize safety and any procedural issues associated with TTT drug administration of OTO-201.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bilateral Middle Ear Effusion
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
33 (Actual)
8. Arms, Groups, and Interventions
Arm Title
OTO-201
Arm Type
Experimental
Arm Description
6 mg OTO-201 administered trans-tympanostomy tube
Intervention Type
Drug
Intervention Name(s)
OTO-201
Primary Outcome Measure Information:
Title
Otoscopic Examination: Auricle and Meatus
Description
Number of ears whose external ear and ear canal (auricle and meatus), when examined through an otoscope, appeared normal at Baseline and appeared abnormal at Day 29
Time Frame
Up to 1 month
Title
Otoscopic Examination: Tympanic Membrane
Description
Number of ears whose ear drum (tympanic membrane), when examined through an otoscope, appeared normal at Baseline and appeared abnormal at Day 29
Time Frame
up to 1 month
Title
Otoscopic Examination: Tube Patency
Description
Subjects with at least one ear tube patent (i.e., not blocked) at Day 29
Time Frame
Up to 1 month
Secondary Outcome Measure Information:
Title
Feasibility of Administration
Description
Ease of administering OTO-201 through the tympanostomy tube: Number of subjects that investigators rated ease of administration as either "easy" or "very easy"
Time Frame
Day 1
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Months
Maximum Age & Unit of Time
17 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 17 years, inclusive
Subject has a clinical diagnosis of bilateral middle ear effusion requiring tympanostomy tube placement
Subject's caregiver is willing to comply with the protocol an attend all study visits
Exclusion Criteria includes, but is not limited to:
Subject has a history of prior ear or mastoid surgery, not including myringotomy or myringotomy with tympanostomy tube placement
Subject has a history of sensorineural hearing loss
Subject has been designated for any other surgical procedure that would occur concurrently with TT placement, such as, but not limited to adenoidectomy or tonsillectomy
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
Central California Ear, Nose and Throat
City
Fresno
State/Province
California
Country
United States
Facility Name
Charlotte Eye, Ear, Nose and Throat Associates
City
Charlotte
State/Province
North Carolina
Country
United States
Facility Name
Charlotte Eye, Ear, Nose and Throat Associates
City
Matthews
State/Province
North Carolina
Country
United States
Facility Name
Piedmont Ear, Nose and Throat
City
Winston-Salem
State/Province
North Carolina
Country
United States
Facility Name
Carolina Ear, Nose and Throat
City
Orangeburg
State/Province
South Carolina
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Open-Label Study of OTO-201 for Middle Ear Effusion Evaluating Trans-Tympanostomy Tube Administration
We'll reach out to this number within 24 hrs