Safety and Efficacy of Moxidex Otic

• Status: Terminated
• Trial end date: 2011-10-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Alcon Research
• Treatments: Fluoroquinolones; Moxifloxacin; Norgestimate, ethinyl estradiol drug combination; Pharmaceutical Solutions

Criteria

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