Phase 3Completed
Comparative Efficacy and Safety of Ciprofloxacin 0.3% and Dexamethasone 0.1% in Acute Otitis Externa
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
- Sponsor
- Exela Pharma Sciences, LLC. (Industry)
- Enrolment
- 499 enrolled
- Conditions
- Acute Otitis Externa
- Interventions
- Ciprodex®; EXL CDOS (Ciprofloxacin 0.3% and Dexamethasone 0.1%) Sterile Otic Suspension
- Ages
- children, adults, older adults
- Registry
- NCT02216071
Full record on ClinicalTrials.gov
From the registry
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.
Primary outcomes
- Number of Participants With Clinical Cure of AOE
History
Results first posted
Last registry update
Primary completion
Registered
Started