This was a pilot study to determine the safety and effectiveness of a twice daily, seven-day dosing regimen in acute, pediatric, otitis media in children with tympanostomy tubes. The currently approved regimen is twice daily for 10 days.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
96
ofloxacin otic solution 0.3% instilled twice a day for seven days
Sponsor determined clinical cure of otitis media
Time frame: 7 days
Sponsor determined microbiological cure of otitis media
Time frame: 7 days
Investigator determined clinical cure
Time frame: 7 days
Overall per-subject microbiological outcome
Time frame: 7 days
Overall per pathogen microbiological outcome
Time frame: 7 days
sign and symptoms of otitis media
Time frame: 7 days
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