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OpenTrials
Completed

NCT Number: NCT00578474

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

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.

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Key information

Conditions

Acute Otitis Media Ear Diseases Otitis Otitis Media Otorhinolaryngologic Diseases

Age range

6 month–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Moxidex otic solution

Drug

4 drops into the infected ear(s) twice daily (morning and evening) for 7 days

Ofloxacin otic solution

Drug

5 drops into the infected ear(s) twice daily (morning and evening) for 10 days

Other names: FLOXIN

Tympanostomy tubes

Device

Tubes surgically inserted through the ear drum for the treatment of recurrent otitis media in children

Primary outcomes

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

    Time frame: From baseline

Secondary outcomes

  1. Time to cessation of otorrhea

    Time frame: From baseline

  2. Microbiological outcome

    Time frame: From baseline

  3. Treatment failures

    Time frame: From baseline

Sponsors and collaborators

Lead sponsor

Alcon Research

Industry

Registry information

Official study title

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

Important dates

Study start
2005
Primary completion
2008
Study completion
2008
First posted
Dec 21, 2007
Registry last updated
Dec 3, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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