Safety and Efficacy of Moxidex Otic

Stopped early · Phase 3

Conditions studied: Acute Otitis Media

In brief

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.

Key facts

Study ID

NCT01071902

Run by

Alcon Research

People needed

400

Starts

2010-02-01

Expected to finish

2011-10-01

Last updated by the study team

2012-12-03

Who can join

Age: 1 and older, up to 12. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Contact Alcon Call Center for Trial Locations — Fort Worth, Texas, United States

Full record on ClinicalTrials.gov

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