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

Overview

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.

Full Title of Study: “Safety and Efficacy of a Topical Otic Formulation in the Treatment of Acute Otitis Media With Otorrhea Through Tympanostomy Tubes (AOMT)”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: August 2008

Interventions

  • Drug: Moxidex otic solution
    • 4 drops into the infected ear(s) twice daily (morning and evening) for 7 days
  • Drug: Ofloxacin otic solution
    • 5 drops into the infected ear(s) twice daily (morning and evening) for 10 days
  • Device: Tympanostomy tubes
    • Tubes surgically inserted through the ear drum for the treatment of recurrent otitis media in children

Arms, Groups and Cohorts

  • Experimental: Moxidex
    • Moxidex otic solution
  • Active Comparator: FLOXIN
    • Ofloxacin otic solution

Clinical Trial Outcome Measures

Primary Measures

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

Secondary Measures

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

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 6 Months

Maximum Age: 12 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Alcon Research
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Contact Alcon Call Center, Study Director, 1-888-451-3937

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