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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Alcon Research
ClinicalTrials.gov Identifier:
NCT00578474
First received: December 19, 2007
Last updated: November 29, 2012
Last verified: November 2012
  Purpose

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.


Condition Intervention Phase
Acute Otitis Media
Drug: Moxidex otic solution
Drug: Ofloxacin otic solution
Device: Tympanostomy tubes
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Safety and Efficacy of a Topical Otic Formulation in the Treatment of Acute Otitis Media With Otorrhea Through Tympanostomy Tubes (AOMT)

Resource links provided by NLM:


Further study details as provided by Alcon Research:

Primary Outcome Measures:
  • Clinical cure rate at the test of cure visit as determined by the investigator [ Time Frame: From baseline ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Time to cessation of otorrhea [ Time Frame: From baseline ] [ Designated as safety issue: No ]
  • Microbiological outcome [ Time Frame: From baseline ] [ Designated as safety issue: No ]
  • Treatment failures [ Time Frame: From baseline ] [ Designated as safety issue: No ]

Enrollment: 911
Study Start Date: December 2005
Study Completion Date: August 2008
Primary Completion Date: August 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Drug: Ofloxacin otic solution
5 drops into the infected ear(s) twice daily (morning and evening) for 10 days
Other Name: FLOXIN
Device: Tympanostomy tubes
Tubes surgically inserted through the ear drum for the treatment of recurrent otitis media in children

  Eligibility

Ages Eligible for Study:   6 Months to 12 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00578474

Sponsors and Collaborators
Alcon Research
Investigators
Study Director: Contact Alcon Call Center 1-888-451-3937
  More Information

No publications provided

Responsible Party: Alcon Research
ClinicalTrials.gov Identifier: NCT00578474     History of Changes
Other Study ID Numbers: C-05-35
Study First Received: December 19, 2007
Last Updated: November 29, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Alcon Research:
Acute otitis media
Tympanostomy tubes

Additional relevant MeSH terms:
Otitis
Otitis Media
Ear Diseases
Otorhinolaryngologic Diseases
Ofloxacin
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Infective Agents, Urinary
Renal Agents

ClinicalTrials.gov processed this record on July 20, 2014