Clinical Trial: Comparative Efficacy and Safety of Two Ciprofloxacin 0.3% and Dexamethasone 0.1% Formulations in Subjects With Acute Otitis Externa

Study Status: Terminated
Recruit Status: Unknown status
Study Type: Interventional

Official Title: A Phase 3, Randomized, Double-Blind, Active-Controlled, Parallel-Group Study of the Comparative Efficacy and Safety of EXL CDOS in Subjects With Acute Otitis Externa

Brief Summary: The purpose of the study is to demonstrate the clinical therapeutic non-inferiority of EXL CDOS to commercially available Ciprofloxacin 0.3% and Dexamethasone 0.1% Sterile Otic Suspension (Ciprodex®, Alcon) in the treatment of acute otitis externa (AOE) when administered twice daily for 7 days.

Detailed Summary:
Sponsor: Exela Pharma Sciences, LLC.

Current Primary Outcome: Clinical Cure of AOE [ Time Frame: 7 days after the completion of therapy ]

Original Primary Outcome: Same as current

Current Secondary Outcome: Microbiological Cure (MC) [ Time Frame: 7 days after the completion of therapy ]

Original Secondary Outcome: Same as current

Information By: Exela Pharma Sciences, LLC.

Dates:
Date Received: August 11, 2014
Date Started: July 2014
Date Completion: December 2014
Last Updated: August 12, 2014
Last Verified: August 2014