Phase 3
Completed N=493
Efficacy and Safety of DF289 Plus DF277 Otic Solution in the Treatment of Acute Otitis Externa
Acute Otitis Externa
Source: ClinicalTrials.gov NCT03196973 ↗
Enrolled (actual)
493
Serious AEs
0.2%
Results posted
Apr 2021
Primary outcomePrimary: Therapeutic Cure (Clinical + Microbiological Cure) — 63; 49; 20 Participants
◆ Published Evidence
Emerging
10citations · ~3 / year
Efficacy and Safety of Ciprofloxacin Plus Fluocinolone Acetonide Among Patients With Acute Otitis Externa: A Randomized Clinical Trial.
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
Linked Publications
-
Efficacy and Safety of Ciprofloxacin Plus Fluocinolone Acetonide Among Patients With Acute Otitis Externa: A Randomized Clinical Trial.
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 | — |
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
Data sourced from ClinicalTrials.gov (NCT03196973) and the linked publication. 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. Informational only — not medical advice.