Efficacy and Safety of DF289 Plus DF277 Otic Solution in the Treatment of Acute Otitis Externa (NCT03196973) | Clinical Trial Compass
CompletedPhase 3
Efficacy and Safety of DF289 Plus DF277 Otic Solution in the Treatment of Acute Otitis Externa
Spain493 participantsStarted 2017-07-22
Plain-language summary
The purpose of this study is to determine if a combination of an antibiotic plus a corticosteroid is safe and effective in treating AOE
Who can participate
Age range6 Months
SexALL
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Inclusion Criteria:
* Uncomplicated AOE of less tan 21 days, defined as a total symptom score of at least 2 for otalgia, 2 for edema and 1 for otorrhea
* Brighton Grading of II or III
* Culture-based diagnosis of acute bacterial otitis externa
* Willingness to refrain from swimming through end of the study
Exclusion Criteria:
* Previous episode of AOE within 4 weeks prior to enrollment, or 2 or more episodes of AOE within 6 months prior to the enrollment.
* Tympanic membrane perforation
* Any condition or situation likely to cause the patient to be unable or unwilling to comply with study treatment or attend all study visits
* Any condition in the patient or parent/guardian that, in the judgment of the principal investigator, could compromise patient safety, limit the patient's ability to complete the study, and/or compromise the objectives of the study