Safety and Efficacy of Moxidex Otic

November 29, 2012 updated by: Alcon Research

Safety and Efficacy Evaluation of Topical Moxidex Otic Solution in the Treatment of Acute Otitis Media With Otorrhea in Tympanostomy Tubes

The purpose of this study is to determine if Moxidex otic solution is safe and effective in treating middle ear infections in patients with ear tubes.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

400

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

  • United States
    • Texas
      • Fort Worth, Texas, United States, 76134
        • Contact Alcon Call Center 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

2 years to 8 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 6 months to 12 years of age
  • Ear tubes in one or both ears
  • Ear drainage visible by parent/guardian
  • Ear drainage less than 21 days
  • Other protocol-defined inclusion criteria may apply

Exclusion Criteria:

  • Patients not otorrhea-free for 7 or less following tympanostomy tube surgery
  • Ear tube with antimicrobial activity; ear tube longer than 2.5mm
  • Non-tube otorrhea
  • No otic surgery other than tube placement in the last year
  • No menarchial females; no diabetic patients
  • No patients with any disease or condition that would negatively affect the conduct of the study
  • No patients taking 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
  • Patients may not be predisposed to neurosensory hearing loss
  • 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: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Vehicle
Device: Tympanostomy tubes
Tubes surgically inserted through the ear drum for the treatment of recurrent otitis media in children
Other: Vehicle
4 drops into the infected ear(s) twice daily (morning and evening) for 7 days
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: Moxifloxacin
Moxifloxacin otic solution
Device: Tympanostomy tubes
Tubes surgically inserted through the ear drum for the treatment of recurrent otitis media in children
Drug: Moxifloxacin otic solution
4 drops into the infected ear(s) twice daily (morning and evening) for 7 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Clinical Cure at End of Treatment
Time Frame: Day 8
Day 8

Secondary Outcome Measures

Outcome Measure
Time Frame
Time to Cessation of Otorrhea
Time Frame: From First Dose
From First Dose
Microbiological Success at End of Treatment
Time Frame: Day 8
Day 8

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

February 1, 2010

Primary Completion (Actual)

October 1, 2011

Study Completion (Actual)

October 1, 2011

Study Registration Dates

First Submitted

February 18, 2010

First Submitted That Met QC Criteria

February 18, 2010

First Posted (Estimate)

February 19, 2010

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-09-033

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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