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

• Status: Completed
• Trial end date: 2018-09-14
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Salvat
• Treatments: Anti-Bacterial Agents; Antibiotics, Antitubercular; Pharmaceutical Solutions

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