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

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

Official Title
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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)

Conditions
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Acute Otitis Externa

Intervention / Treatment
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* Drug: DF289 plus DF277
* Drug: DF289
* Drug: DF277


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 6 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: DF289 plus DF277<br>Otic solution | Drug: DF289 plus DF277<br>* 1 vial into the affected ear twice daily for 7 days<br>* Other names: Antibiotic and Corticosteroid;|
| Active Comparator: DF289<br>Otic solution | Drug: DF289<br>* 1 vial into the affected ear twice daily for 7 days<br>* Other names: Antibiotic;|
| Active Comparator: DF277<br>Otic solution | Drug: DF277<br>* 1 vial into the affected ear twice daily for 7 days<br>* Other names: Corticosteroid;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Therapeutic Cure (Clinical + Microbiological Cure) | Therapeutic cure will be considered achieved if edema, otalgia and otorrhea are resolved with no further requirement of antimicrobial therapy and bacteriological response is Eradication or Presumed Eradication | End of Treatment (Day 8+2) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to End of Pain | First day on which there is no use of analgesics, the pain score is zero and remains zero until end of study | From baseline to End of Study (Day 15+2) |