NCT00578773
Completed
Phase 2
Safety and Efficacy of a Topical Otic Formulation in the Treatment of Peri-Operative Tube Otorrhea
ConditionsAcute Otitis Media
Overview
- Phase
- Phase 2
- Intervention
- Moxidex otic solution
- Conditions
- Acute Otitis Media
- Sponsor
- Alcon Research
- Enrollment
- 303
- Primary Endpoint
- Time to cessation of otorrhea as recorded by the parent or guardian via a patient diary
- Status
- Completed
- Last Updated
- 13 years ago
Overview
Brief Summary
The purpose of this study is to determine if an otic formulation is safe and effective in treating peri-operative tube otorrhea.
Investigators
Eligibility Criteria
Inclusion Criteria
- •6 months to 12 years old
- •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
Exclusion Criteria
- •Other protocol-defined exclusion criteria may apply
Arms & Interventions
Moxidex
Moxidex otic solution
Intervention: Moxidex otic solution
Moxidex
Moxidex otic solution
Intervention: Tympanostomy tubes
Moxifloxacin
Moxifloxacin otic solution
Intervention: Moxifloxacin otic solution
Moxifloxacin
Moxifloxacin otic solution
Intervention: Tympanostomy tubes
TT only
Tympanostomy tubes only
Intervention: Tympanostomy tubes
Outcomes
Primary Outcomes
Time to cessation of otorrhea as recorded by the parent or guardian via a patient diary
Time Frame: From baseline
Secondary Outcomes
- Clinical cures at each visit(From baseline)
- Absence of otorrhea at each visit(From baseline)
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