A Phase II Study of an Otic Formulation in Treating Peri-Operative Tube Otorrhea
Phase 2
Completed
- Conditions
- Acute Otitis Media
- Interventions
- Registration Number
- NCT00578773
- Lead Sponsor
- Alcon Research
- Brief Summary
The purpose of this study is to determine if an otic formulation is safe and effective in treating peri-operative tube otorrhea.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 303
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
- 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
- Other protocol-defined exclusion criteria may apply
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Moxidex Moxidex otic solution Moxidex otic solution Moxidex Tympanostomy tubes Moxidex otic solution Moxifloxacin Moxifloxacin otic solution Moxifloxacin otic solution Moxifloxacin Tympanostomy tubes Moxifloxacin otic solution TT only Tympanostomy tubes Tympanostomy tubes only
- Primary Outcome Measures
Name Time Method Time to cessation of otorrhea as recorded by the parent or guardian via a patient diary From baseline
- Secondary Outcome Measures
Name Time Method Clinical cures at each visit From baseline Absence of otorrhea at each visit From baseline