Clinical Drug Experience Knowledgebase

Criteria

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.