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

This was a Phase 3, multicenter, randomized, double-blind, active-controlled, parallel-group study in adults and children (age 6 months and older) with a diagnosis of AOE with a 2-day screening period followed by a 2-week participation period. Subjects were administered study drug, EXL CDOS or RLD, 4 drops in the affected ear(s) BID for 7 days. The primary endpoint, the proportion of subjects with a clinical AOE score of 0, was measured at the TOC Visit on Day 15.

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 <4 weeks duration;
• Intact tympanic membrane(s) in the treated ear(s);
• Willingness to refrain from swimming through the TOC/ Visit 5;
• 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;
• Ability to complete the study in compliance with the protocol;
• For adult subjects, ability to understand and provide written informed consent; and
• For pediatric subjects, a parent or legal guardian has provided written informed consent; and
• For children age 6 and above, ability to understand and provide assent according to institutional requirements.

Exclusion criteria

• Acute or chronic suppurative otitis media;
• Post-tympanostomy tube acute otorrhea;
• Malignant otitis externa;
• Suspected or overt fungal or viral ear infection;
• Congenital abnormalities or obstructive bony exostoses of the external auditory canal of the treated ear(s);
• Seborrheic dermatitis or other dermatologic conditions of the external auditory canal of the treated ear(s) which could confound evaluation;
• Mastoiditis or other suppurative infectious or non-infectious disorders of the treated ear(s);
• Malignant tumors of the external auditory canal of the treated ear(s);
• History of otologic surgery of the treated ear(s), with the exception of tympanic membrane surgery >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.