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A Phase III Study of an Otic Formulation in Acute Otitis Media With Tympanostomy Tubes

Primary Purpose

Acute Otitis Media

Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Moxidex otic solution
Ofloxacin otic solution
Tympanostomy tubes
Sponsored by
Alcon Research
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Otitis Media focused on measuring Acute otitis media, Tympanostomy tubes

Eligibility Criteria

6 Months - 12 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 6 months to 12 years old
  • Ear tubes in one or both ears
  • Ear drainage visible by the parent / guardian
  • Ear drainage less than 21 days
  • Ear tube may not be silver oxide, silver salt, t-type tube or long-shafted tube
  • Patient may not have non-tube otorrhea
  • Patient may not have had otic surgery other than tube placement in the last year
  • Patient may not be a menarchal female
  • Diabetic patients are not eligible
  • Patient may not have any disease or condition that would negatively affect the conduct of the study
  • Patient may not require any other systemic antimicrobial therapy during the study
  • Patient must meet certain medication washouts to be eligible
  • Analgesic use (other than acetaminophen) is not allowed
  • Patient may not be pre-disposed to neurosensory hearing loss
  • Other protocol-defined inclusion criteria may apply

Exclusion Criteria:

  • Age related
  • Other protocol-defined exclusion criteria may apply

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Moxidex

    FLOXIN

    Arm Description

    Moxidex otic solution

    Ofloxacin otic solution

    Outcomes

    Primary Outcome Measures

    Clinical cure rate at the test of cure visit as determined by the investigator

    Secondary Outcome Measures

    Time to cessation of otorrhea
    Microbiological outcome
    Treatment failures

    Full Information

    First Posted
    December 19, 2007
    Last Updated
    November 29, 2012
    Sponsor
    Alcon Research
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00578474
    Brief Title
    A Phase III Study of an Otic Formulation in Acute Otitis Media With Tympanostomy Tubes
    Official Title
    Safety and Efficacy of a Topical Otic Formulation in the Treatment of Acute Otitis Media With Otorrhea Through Tympanostomy Tubes (AOMT)
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    November 2012
    Overall Recruitment Status
    Completed
    Study Start Date
    December 2005 (undefined)
    Primary Completion Date
    August 2008 (Actual)
    Study Completion Date
    August 2008 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Alcon Research

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The purpose of this study is to determine if an otic formulation is safe and effective in treating middle ear infections in patients with ear tubes.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Acute Otitis Media
    Keywords
    Acute otitis media, Tympanostomy tubes

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    911 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Moxidex
    Arm Type
    Experimental
    Arm Description
    Moxidex otic solution
    Arm Title
    FLOXIN
    Arm Type
    Active Comparator
    Arm Description
    Ofloxacin otic solution
    Intervention Type
    Drug
    Intervention Name(s)
    Moxidex otic solution
    Intervention Description
    4 drops into the infected ear(s) twice daily (morning and evening) for 7 days
    Intervention Type
    Drug
    Intervention Name(s)
    Ofloxacin otic solution
    Other Intervention Name(s)
    FLOXIN
    Intervention Description
    5 drops into the infected ear(s) twice daily (morning and evening) for 10 days
    Intervention Type
    Device
    Intervention Name(s)
    Tympanostomy tubes
    Intervention Description
    Tubes surgically inserted through the ear drum for the treatment of recurrent otitis media in children
    Primary Outcome Measure Information:
    Title
    Clinical cure rate at the test of cure visit as determined by the investigator
    Time Frame
    From baseline
    Secondary Outcome Measure Information:
    Title
    Time to cessation of otorrhea
    Time Frame
    From baseline
    Title
    Microbiological outcome
    Time Frame
    From baseline
    Title
    Treatment failures
    Time Frame
    From baseline

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    6 Months
    Maximum Age & Unit of Time
    12 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: 6 months to 12 years old Ear tubes in one or both ears Ear drainage visible by the parent / guardian Ear drainage less than 21 days Ear tube may not be silver oxide, silver salt, t-type tube or long-shafted tube Patient may not have non-tube otorrhea Patient may not have had otic surgery other than tube placement in the last year Patient may not be a menarchal female Diabetic patients are not eligible Patient may not have any disease or condition that would negatively affect the conduct of the study Patient may not require any other systemic antimicrobial therapy during the study Patient must meet certain medication washouts to be eligible Analgesic use (other than acetaminophen) is not allowed Patient may not be pre-disposed to neurosensory hearing loss Other protocol-defined inclusion criteria may apply Exclusion Criteria: Age related Other protocol-defined exclusion criteria may apply
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Contact Alcon Call Center
    Organizational Affiliation
    1-888-451-3937
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Learn more about this trial

    A Phase III Study of an Otic Formulation in Acute Otitis Media With Tympanostomy Tubes

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