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

Phase 3

Completed

• Conditions: Acute Otitis Media
• Interventions: Drug: Ofloxacin otic solution; Drug: Moxidex otic solution; Device: Tympanostomy tubes

• Registration Number: NCT00578474
• Lead Sponsor: Alcon Research

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2005-12
• Study First Submitted: 2007-12-19
• Study First Submitted QC: 2007-12-20
• Study First Posted: 2007-12-21
• Primary Completion: 2008-08
• Study Completion: 2008-08
• Status Verified: 2012-11
• Disposition First Submitted: 2012-11-28
• Disposition First Submitted QC: 2012-11-28
• Last Update Submitted: 2012-11-29
• Disposition First Posted: 2012-11-30
• Last Update Posted: 2012-12-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 911

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Moxidex	Tympanostomy tubes	Moxidex otic solution
FLOXIN	Ofloxacin otic solution	Ofloxacin otic solution
FLOXIN	Tympanostomy tubes	Ofloxacin otic solution
Moxidex	Moxidex otic solution	Moxidex otic solution

Primary Outcome Measures

Name	Time	Method
Clinical cure rate at the test of cure visit as determined by the investigator	From baseline

Secondary Outcome Measures

Name	Time	Method
Time to cessation of otorrhea	From baseline
Microbiological outcome	From baseline
Treatment failures	From baseline