Open-Label Study of OTO-201 in Pediatric Subjects With a History of Otitis Media Requiring Tympanostomy Tubes

September 21, 2020 updated by: Otonomy, Inc.

An 8-Week, Prospective, Multicenter, Open-Label Study of OTO-201 Given as a Single Administration in Pediatric Subjects With a History of Otitis Media Requiring Tympanostomy Tubes

This is an 8-week, multicenter, open-label study in which eligible subjects with a history of otitis media requiring TT placement will receive 6 mg OTO-201 to each ear. The study is designed to evaluate the safety and efficacy of OTO-201 in subjects undergoing TT placement with common concurrent surgeries and any middle ear effusion status.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

501

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • California
      • San Diego, California, United States, 92121
        • Email Otonomy Central Contact for Trial Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 months to 17 years (CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria includes, but is not limited to:

  • Subject is a male or female aged 6 months to 17 years, inclusive
  • Subject has a history of otitis media requiring bilateral tympanostomy tube placement
  • 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 a history of prior ear or mastoid surgery, not including myringotomy or myringotomy with TT placement
  • Subject has been designated for any other surgical procedure that would occur concurrently with TT placement, except adenoidectomy, airway endoscopy, nasal endoscopy, and nasal cautery for epistaxis
  • Subject has a history of sensorineural hearing loss

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: 0.1 mL OTO-201
Ciprofloxacin
Other Names:
  • OTIPRIO

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Subjects With Post-surgical Otorrhea
Time Frame: Week 4
Absence or presence of otorrhea (drainage from the middle ear)
Week 4
Number of Subjects With Post-surgical Otorrhea
Time Frame: 8 weeks
Absence or presence of otorrhea (drainage from the middle ear)
8 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adverse Events
Time Frame: Up to Eight Weeks
Evaluation of adverse events
Up to Eight Weeks
Caregiver Burden - Ear Discharge Control
Time Frame: Week 4
Ear Drop Caregiver Burden Questionnaire at Week 4
Week 4
Caregiver Burden - Ear Discharge Control
Time Frame: Week 8
Ear Drop Caregiver Burden Questionnaire at Week 8
Week 8
Caregiver Burden - Ear Drops Administration
Time Frame: Week 8
Ear Drop Caregiver Burden Questionnaire at Week 8
Week 8

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Investigators

  • Study Chair: Dean Hakanson, MD, Otonomy, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2015

Primary Completion (ACTUAL)

July 1, 2016

Study Completion (ACTUAL)

July 1, 2016

Study Registration Dates

First Submitted

November 5, 2015

First Submitted That Met QC Criteria

November 5, 2015

First Posted (ESTIMATE)

November 9, 2015

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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