NCT02216071

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 499 (actual)
• Sponsor: Exela Pharma Sciences, LLC. · Industry
• Sex: All
• Age: 6 Months
• Healthy volunteers: Not accepted

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 description

This was a Phase 3, multicenter, randomized, double-blind, active-controlled, parallel-group study in adults and children (age 6 months and older) with a diagnosis of AOE with a 2-day screening period followed by a 2-week participation period. Subjects were administered study drug, EXL CDOS or RLD, 4 drops in the affected ear(s) BID for 7 days. The primary endpoint, the proportion of subjects with a clinical AOE score of 0, was measured at the TOC Visit on Day 15.

Conditions

• Acute Otitis Externa

Interventions

Type	Name	Description
DRUG	Ciprodex®	Treatment of acute otitis externa (AOE) when administered twice daily for 7 days
DRUG	EXL CDOS (Ciprofloxacin 0.3% and Dexamethasone 0.1%) Sterile Otic Suspension	Treatment of acute otitis externa (AOE) when administered twice daily for 7 days

Timeline

• Start date: 2014-07-20
• Primary completion: 2015-08-11
• Completion: 2015-08-11
• First posted: 2014-08-13
• Last updated: 2021-05-28
• Results posted: 2021-05-28

Locations

48 sites across 2 countries: United States, Puerto Rico