The purpose of this study is to determine if an 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
911
4 drops into the infected ear(s) twice daily (morning and evening) for 7 days
5 drops into the infected ear(s) twice daily (morning and evening) for 10 days
Tubes surgically inserted through the ear drum for the treatment of recurrent otitis media in children
Clinical cure rate at the test of cure visit as determined by the investigator
Time frame: From baseline
Time to cessation of otorrhea
Time frame: From baseline
Microbiological outcome
Time frame: From baseline
Treatment failures
Time frame: From baseline
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