Safety and Efficacy of Moxidex Otic

Safety and Efficacy Evaluation of Topical Moxidex Otic Solution in the Treatment of Acute Otitis Media With Otorrhea in Tympanostomy Tubes

The purpose of this study is to determine if Moxidex otic solution is safe and effective in treating middle ear infections in patients with ear tubes.

Inclusion Criteria:

• 6 months to 12 years of age
• Ear tubes in one or both ears
• Ear drainage visible by parent/guardian
• Ear drainage less than 21 days
• Other protocol-defined inclusion criteria may apply

Exclusion Criteria:

• Patients not otorrhea-free for 7 or less following tympanostomy tube surgery
• Ear tube with antimicrobial activity; ear tube longer than 2.5mm
• Non-tube otorrhea
• No otic surgery other than tube placement in the last year
• No menarchial females; no diabetic patients
• No patients with any disease or condition that would negatively affect the conduct of the study
• No patients taking 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
• Patients may not be predisposed to neurosensory hearing loss
• Other protocol-defined exclusion criteria may apply