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

November 29, 2012 updated by: Alcon Research

Safety and Efficacy of a Topical Otic Formulation in the Treatment of Acute Otitis Media With Otorrhea Through Tympanostomy Tubes (AOMT)

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

911

Phase

  • Phase 3

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 12 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

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: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Moxidex
Moxidex otic solution
Drug: Moxidex otic solution
4 drops into the infected ear(s) twice daily (morning and evening) for 7 days
Device: Tympanostomy tubes
Tubes surgically inserted through the ear drum for the treatment of recurrent otitis media in children
Active Comparator: FLOXIN
Ofloxacin otic solution
Device: Tympanostomy tubes
Tubes surgically inserted through the ear drum for the treatment of recurrent otitis media in children
Drug: Ofloxacin otic solution
5 drops into the infected ear(s) twice daily (morning and evening) for 10 days
Other Names:
  • FLOXIN

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Clinical cure rate at the test of cure visit as determined by the investigator
Time Frame: From baseline
From baseline

Secondary Outcome Measures

Outcome Measure
Time Frame
Time to cessation of otorrhea
Time Frame: From baseline
From baseline
Microbiological outcome
Time Frame: From baseline
From baseline
Treatment failures
Time Frame: From baseline
From baseline

Collaborators and Investigators

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

Sponsor

Alcon Research

Investigators

  • Study Director: Contact Alcon Call Center, 1-888-451-3937

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

December 1, 2005

Primary Completion (Actual)

August 1, 2008

Study Completion (Actual)

August 1, 2008

Study Registration Dates

First Submitted

December 19, 2007

First Submitted That Met QC Criteria

December 20, 2007

First Posted (Estimate)

December 21, 2007

Study Record Updates

Last Update Posted (Estimate)

December 3, 2012

Last Update Submitted That Met QC Criteria

November 29, 2012

Last Verified

November 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • C-05-35

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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