Safety and Efficacy of Floxin Otic Solution in the Treatment of Acute Otitis Media in Children

A Pilot, Multicenter, Open Label, Non Comparative Study of the Safety and Efficacy of Floxin Otic Solution in the Treatment of Acute Otitis Media Twice Daily for Seven Days in Children With Tympanostomy Tubes

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.

Inclusion Criteria:

• Male or female
• 6 months of age to <12 years of age
• weight = or >4.5 kg
• Patent tympanostomy tube(s) in the affected ear(s)
• Purulent or mucopurulent otorrhea of recent onset of presumed bacterial origin

Exclusion Criteria:

• Non-bacterial otic infection
• Known or suspected hypersensitivity to ofloxacin
• Cystic fibrosis
• HIV infection
• Neutropenia
• Receiving immunosuppressive therapy