A Phase II Study of an Otic Formulation in Treating Peri-Operative Tube Otorrhea

Safety and Efficacy of a Topical Otic Formulation in the Treatment of Peri-Operative Tube Otorrhea

The purpose of this study is to determine if an otic formulation is safe and effective in treating peri-operative tube otorrhea.

Inclusion Criteria:

• 6 months to 12 years old
• Diagnosed with recurrent acute otitis media or chronic otitis media with effusion
• Must be first set of ear tubes.
• Patient may not have had any other previous otologic-related surgery.
• Ear tube may not be silver oxide, silver salt, t-type tube or long-shafted tube
• Patient may not have existing perforation of the eardrum.
• Patient must not require another surgical procedure other than myringotomy and tube insertion.
• 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