Comparative Efficacy and Safety of Ciprofloxacin 0.3% and Dexamethasone 0.1% in Acute Otitis Externa

Inclusion Criteria

• Male or female, 6 months of age and over;
• Clinically documented AOE consistent with the diagnostic guidelines of the American Academy of Otolaryngology-Head and Neck Surgery Foundation in 1 or both ears;
• Inflammation and/or edema ≥2 on the AOE scale, and otorrhea and/or tenderness present;
• AOE of 6 months prior to Baseline;
• Four or more episodes of otitis externa (OE) in the previous year;
• Uncontrolled diabetes mellitus;
• Immunosuppressive disorder, including known Human Immunodeficiency Virus infection;
• Renal insufficiency;
• Hepatitis or hepatic insufficiency;
• Receipt of systemic antibiotic concurrently or within 72 hours prior to Baseline;
• Receipt of topical otic antibiotic within 24 hours prior to Baseline;
• Use of systemic corticosteroid concurrently or within 30 days prior to Baseline;
• Use of topical otic corticosteroids concurrently or within 7 days prior to Baseline;
• Concurrent use of systemic or topical otic nonsteroidal or other anti-inflammatory drugs;
• Use of topical vinegar, alcohol, or other astringent otic preparations concurrently or within 24 hours prior to Baseline;
• Pregnancy, planned pregnancy, or lactation;
• Known sensitivity or intolerance to quinolone antibacterial agents;
• Previous participation in this trial;
• Participation in another investigational drug or vaccine trial concurrently or within 30 days; or
• Significant acute or chronic medical, neurologic, or psychiatric illness in the subject or parent/guardian that, in the judgment of the Principal Investigator, could compromise subject safety, limit the subject's ability to complete the study, and/or compromise the objectives of the study.