Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE3
400 participants
INTERVENTIONAL
2010-02-28
2011-10-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Moxidex
Moxidex otic solution
Moxidex otic solution
4 drops into the infected ear(s) twice daily (morning and evening) for 7 days
Tympanostomy tubes
Tubes surgically inserted through the ear drum for the treatment of recurrent otitis media in children
Moxifloxacin
Moxifloxacin otic solution
Moxifloxacin otic solution
4 drops into the infected ear(s) twice daily (morning and evening) for 7 days
Tympanostomy tubes
Tubes surgically inserted through the ear drum for the treatment of recurrent otitis media in children
Vehicle
Vehicle
Vehicle
4 drops into the infected ear(s) twice daily (morning and evening) for 7 days
Tympanostomy tubes
Tubes surgically inserted through the ear drum for the treatment of recurrent otitis media in children
Interventions
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Moxidex otic solution
4 drops into the infected ear(s) twice daily (morning and evening) for 7 days
Moxifloxacin otic solution
4 drops into the infected ear(s) twice daily (morning and evening) for 7 days
Vehicle
4 drops into the infected ear(s) twice daily (morning and evening) for 7 days
Tympanostomy tubes
Tubes surgically inserted through the ear drum for the treatment of recurrent otitis media in children
Eligibility Criteria
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Inclusion Criteria
* Ear tubes in one or both ears
* Ear drainage visible by parent/guardian
* Ear drainage less than 21 days
Exclusion Criteria
* Ear tube with antimicrobial activity; ear tube longer than 2.5mm
* Non-tube otorrhea
* No otic surgery other than tube placement in the last year
* No menarchial females; no diabetic patients
* No patients with any disease or condition that would negatively affect the conduct of the study
* No patients taking 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
* Patients may not be predisposed to neurosensory hearing loss
6 Months
12 Years
ALL
No
Sponsors
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Alcon Research
INDUSTRY
Responsible Party
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Principal Investigators
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Contact Alcon Call Center
Role: STUDY_DIRECTOR
1-888-451-3937
Locations
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Contact Alcon Call Center for Trial Locations
Fort Worth, Texas, United States
Countries
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Other Identifiers
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C-09-033
Identifier Type: -
Identifier Source: org_study_id