At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 493 enrolled
Drug / intervention
DF289 plus DF277 +2 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase III, Multicenter, Randomized, Double-Blind Clinical Trial to Assess the Efficacy and Safety of DF289 Plus DF277 Otic Solution Compared to DF289 Otic Solution and to DF277 Otic Solution in the Treatment of Acute Otitis Externa (AOE)
In Brief
A Phase 3 clinical trial evaluating DF289 plus DF277, DF289, and 1 other intervention for Acute Otitis Externa. Completed, enrolled 493 participants across 1 site.
Detailed 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
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAcute Otitis Externa
CountriesSpain
Collaborators--
Timeline
Phase 3CompletedFinished
201820192020202120222023202420252026
First PostedJun 2017
Enrollment StartJul 2017
Primary CompletionAug 2018
Study CompletionSep 2018
TodayJul 2026
First PostedJun 23, 2017
Enrollment StartJul 22, 2017
Primary CompletionAug 31, 2018
Study CompletionSep 14, 2018
TodayJul 2, 2026
Enrollment to primary: 1.1 yearsPosted 9.0 years ago
Interventions
DF289 plus DF277drug
1 vial into the affected ear twice daily for 7 days
DF289drug
1 vial into the affected ear twice daily for 7 days
DF277drug
1 vial into the affected ear twice daily for 7 days