A Phase II Study of an Otic Formulation in Treating Peri-Operative Tube Otorrhea
NCT ID: NCT00578773
Last Updated: 2012-12-03
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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COMPLETED
PHASE2
303 participants
INTERVENTIONAL
2007-11-30
2009-01-31
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
SINGLE
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
TT only
Tympanostomy tubes only
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
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
* Diagnosed with recurrent acute otitis media or chronic otitis media with effusion
* Must be first set of ear tubes.
* Patient may not have had any other previous otologic-related surgery.
* Ear tube may not be silver oxide, silver salt, t-type tube or long-shafted tube
* Patient may not have existing perforation of the eardrum.
* Patient must not require another surgical procedure other than myringotomy and tube insertion.
* 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
Exclusion Criteria
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
Countries
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Other Identifiers
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C-05-38
Identifier Type: -
Identifier Source: org_study_id