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Clinical Trials/NCT00578474
NCT00578474
Completed
Phase 3

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

Alcon Research0 sites911 target enrollmentDecember 2005
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ConditionsAcute Otitis Media
InterventionsMoxidex otic solutionTympanostomy tubesOfloxacin otic solution
DrugsMoxidex otic solutionOfloxacin otic solution

Overview

Phase
Phase 3
Intervention
Moxidex otic solution
Conditions
Acute Otitis Media
Sponsor
Alcon Research
Enrollment
911
Primary Endpoint
Clinical cure rate at the test of cure visit as determined by the investigator
Status
Completed
Last Updated
13 years ago
OverviewInvestigatorsEligibility CriteriaArms & InterventionsOutcomesSimilar Trials

Overview

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.

Registry
clinicaltrials.gov
Start Date
December 2005
End Date
August 2008
Last Updated
13 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

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

Exclusion Criteria

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

Arms & Interventions

Moxidex

Moxidex otic solution

Intervention: Moxidex otic solution

Moxidex

Moxidex otic solution

Intervention: Tympanostomy tubes

FLOXIN

Ofloxacin otic solution

Intervention: Ofloxacin otic solution

FLOXIN

Ofloxacin otic solution

Intervention: Tympanostomy tubes

Outcomes

Primary Outcomes

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

Time Frame: From baseline

Secondary Outcomes

  • Microbiological outcome(From baseline)
  • Treatment failures(From baseline)
  • Time to cessation of otorrhea(From baseline)

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