Clinical Trial: A Phase III Study of an Otic Formulation in Acute Otitis Media With Tympanostomy Tubes
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: Safety and Efficacy of a Topical Otic Formulation in the Treatment of Acute Otitis Media With Otorrhea Through Tympanostomy Tubes (AOMT)
Brief Summary: The purpose of this study is to determine if an otic formulation is safe and effective in treating middle ear infections in patients with ear tubes.
Detailed Summary:
Sponsor: Alcon Research
Current Primary Outcome: Clinical cure rate at the test of cure visit as determined by the investigator [ Time Frame: From baseline ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Time to cessation of otorrhea [ Time Frame: From baseline ]
- Microbiological outcome [ Time Frame: From baseline ]
- Treatment failures [ Time Frame: From baseline ]
Original Secondary Outcome: Same as current
Information By: Alcon Research
Dates:
Date Received: December 19, 2007
Date Started: December 2005
Date Completion:
Last Updated: November 29, 2012
Last Verified: November 2012
