The purpose of this study is to determine if a topical otic formulation is safe and effective in treating middle ear infections in patients with ear tubes.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
776
4 drops into the infected ear(s) twice daily (morning and evening) for 7 days
4 drops into the infected ear(s) twice daily (morning and evening) for 7 days
Tubes surgically inserted through the ear drum for the treatment of recurrent otitis media in children
Time to cessation of otorrhea as recorded by the parent or guardian via a patient diary
Time frame: From baseline
Clinical cure rate
Time frame: From baseline
Microbiological outcome
Time frame: From baseline
Treatment failures
Time frame: From baseline
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