drugset / Trial / NCT02216071

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

NCT02216071

Phase 3 Completed 499 enrolled Exela Pharma Sciences, LLC.
RandomizedParallel-groupQuadruple-blindTreatment

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.

Timeline

Start
2014-07-20
Primary completion
2015-08-11
Completion
2015-08-11

Drugs

EvaluationDrugModalityDoseRoute
Subject Ciprofloxacin Small molecule 0.3 %
Subject Dexamethasone Small molecule 0.1 %

Indications