Comparative Efficacy and Safety of Ciprofloxacin 0.3% and Dexamethasone 0.1% in Acute Otitis Externa (NCT02216071) | Clinical Trial Compass
CompletedPhase 3
Comparative Efficacy and Safety of Ciprofloxacin 0.3% and Dexamethasone 0.1% in Acute Otitis Externa
United States499 participantsStarted 2014-07-20
Plain-language 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.
Who can participate
Age range6 Months
SexALL
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Inclusion criteria
✓. Male or female, 6 months of age and over;
✓. Clinically documented AOE consistent with the diagnostic guidelines of the American Academy of Otolaryngology-Head and Neck Surgery Foundation in 1 or both ears;
✓. Inflammation and/or edema ≥2 on the AOE scale, and otorrhea and/or tenderness present;
✓. AOE of \<4 weeks duration;
✓. Intact tympanic membrane(s) in the treated ear(s);
✓. Willingness to refrain from swimming through the TOC/ Visit 5;
✓. For subjects with AOE associated with hearing aid use, willingness to discontinue the use of hearing aid(s) in the affected ear(s) through the TOC/Visit 5;
✓. Ability to complete the study in compliance with the protocol;
Exclusion criteria
✕. Acute or chronic suppurative otitis media;
✕. Post-tympanostomy tube acute otorrhea;
✕. Malignant otitis externa;
✕. Suspected or overt fungal or viral ear infection;
✕. Congenital abnormalities or obstructive bony exostoses of the external auditory canal of the treated ear(s);
What they're measuring
1
Number of Participants With Clinical Cure of AOE
Timeframe: 7 days after the completion of therapy; at Day 15 (+/- 1 day)