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

Salvat

Status and phase: Completed; Phase 3

Conditions: Acute Otitis Externa

Treatments: Drug: DF277; Drug: DF289 plus DF277; Drug: DF289

Study type: Interventional

Funder types: Industry

Identifiers

NCT03196973

DF289OT3-16IA01

Details and patient eligibility

About

The purpose of this study is to determine if a combination of an antibiotic plus a corticosteroid is safe and effective in treating AOE

Enrollment: 493 patients

Sex: All

Ages: 6+ months old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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493 participants in 3 patient groups

DF289 plus DF277

Experimental group

Description:

Otic solution

Treatment:

Drug: DF289 plus DF277

DF289

Active Comparator group

Description:

Otic solution

Treatment:

Drug: DF289

DF277

Active Comparator group

Description:

Otic solution

Treatment:

Drug: DF277