Phase III Study of an Otic Formulation in Acute Otitis Media With Tympanostomy Tubes

Safety and Efficacy of a Topical Otic Formulation in the Treatment of Acute Otitis Media With Otorrhea Through Tympanostomy Tubes (AOMT)

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.

Inclusion Criteria:

• 6 months to 12 years old
• Ear tubes in one or both ears
• Ear drainage visible by the parent / guardian
• Ear drainage less than 21 days
• Ear tube may not be silver oxide, silver salt, t-type tube or long-shafted tube
• Patient may not have non-tube otorrhea
• Patient may not have had otic surgery other than tube placement in the last year
• 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