Overview

Comparative Efficacy and Safety of Ciprofloxacin 0.3% and Dexamethasone 0.1% in Acute Otitis Externa

Status:
Completed
Trial end date:
2015-08-11
Target enrollment:
Participant gender:
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.
Phase:
Phase 3
Details
Lead Sponsor:
Exela Pharma Sciences, LLC.
Treatments:
BB 1101
Ciprofloxacin
Dexamethasone
Dexamethasone 21-phosphate
Dexamethasone acetate