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

Inclusion Criteria: 1. Male or female, 6 months of age and over; 2. Clinically documented AOE consistent with the diagnostic guidelines of the American Academy of Otolaryngology-Head and Neck Surgery Foundation in 1 or both ears; 3. Inflammation and/or edema ≥2 on the AOE scale, and otorrhea and/or tenderness present; 4. AOE of \<4 weeks duration; 5. Intact tympanic membrane(s) in the treated ear(s); 6. Willingness to refrain from swimming through the TOC/ Visit 5; 7. For subjects with AOE associated with hearing aid use, willingness to discontinue the use of hearing aid(s) in the affected ear(s) through the TOC/Visit 5; 8. Ability to complete the study in compliance with the protocol; 9. For adult subjects, ability to understand and provide written informed consent; and 10. For pediatric subjects, a parent or legal guardian has provided written informed consent; and 11. For children age 6 and above, ability to understand and provide assent according to institutional requirements. Exclusion Criteria: 1. Acute or chronic suppurative otitis media; 2. Post-tympanostomy tube acute otorrhea; 3. Malignant otitis externa; 4. Suspected or overt fungal or viral ear infection; 5. Congenital abnormalities or obstructive bony exostoses of the external auditory canal of the treated ear(s); 6. Seborrheic dermatitis or other dermatologic conditions of the external auditory canal of the treated ear(s) which could confound evaluation; 7. Mastoiditis or other suppurative infectious or non-infectious disorders of the treated ear(s); 8. Malignant tumors of the external auditory canal of the treated ear(s); 9. History of otologic surgery of the treated ear(s), with the exception of tympanic membrane surgery \>6 months prior to Baseline; 10. Four or more episodes of otitis externa (OE) in the previous year; 11. Uncontrolled diabetes mellitus; 12. Immunosuppressive disorder, including known Human Immunodeficiency Virus infection; 13. Renal insufficiency; 14. Hepatitis or hepatic insufficiency; 15. Receipt of systemic antibiotic concurrently or within 72 hours prior to Baseline; 16. Receipt of topical otic antibiotic within 24 hours prior to Baseline; 17. Use of systemic corticosteroid concurrently or within 30 days prior to Baseline; 18. Use of topical otic corticosteroids concurrently or within 7 days prior to Baseline; 19. Concurrent use of systemic or topical otic nonsteroidal or other anti-inflammatory drugs; 20. Use of topical vinegar, alcohol, or other astringent otic preparations concurrently or within 24 hours prior to Baseline; 21. Pregnancy, planned pregnancy, or lactation; 22. Known sensitivity or intolerance to quinolone antibacterial agents; 23. Previous participation in this trial; 24. Participation in another investigational drug or vaccine trial concurrently or within 30 days; or 25. 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.