Phase 3 N=493 Randomized Quadruple-blind Treatment

Efficacy and Safety of DF289 Plus DF277 Otic Solution in the Treatment of Acute Otitis Externa

Acute Otitis Externa

Bottom Line

View on ClinicalTrials.gov: NCT03196973 ↗

Enrolled (actual)

493

Serious AEs

0.2%

Results posted

Apr 2021

Primary outcome: Primary: Therapeutic Cure (Clinical + Microbiological Cure) — 63; 49; 20 Participants

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: DF289 plus DF277 (Drug); DF289 (Drug); DF277 (Drug)
Age: Pediatric, Adult, Older Adult · 0+ yrs
Sex: All
Sponsor: Salvat
Primary completion: Aug 2018

Outcome Measures

Outcome	Result	p-value
PRIMARY Therapeutic Cure (Clinical + Microbiological Cure)	63; 49; 20	—
SECONDARY Time to End of Pain	5.0; 5.9; 7.7	—

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

Eligibility Criteria

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03196973). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.