Safety and Efficacy Evaluation of Topical AL-60371 Otic Suspension, 0.3% for the Treatment of Acute Otitis Externa

Inclusion Criteria:

- At least 6 months of age.

- Clinical diagnosis of acute otitis externa (AOE) based on clinical observation and of
presumed bacterial origin in at least one ear.

- Combined numerical score of ≥4 in at least one affected ear at the Day 1 exam for
tenderness, erythema, and edema.

- Agree to refrain from water immersion of the ears during the conduct of the entire
study.

- Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

- Duration of signs or symptoms of AOE greater than 28 days in the affected ear(s) as
reported by patient or parent/guardian.

- Presence of a tympanostomy tube or perforated tympanic membrane in the affected
ear(s).

- Clinically diagnosed otic disease other than AOE (eg,malignant otitis externa) in the
affected ear(s).

- Known or suspected ear infection of yeast, fungal or mycobacterial origin in the
affected ear(s).

- Prior otologic surgery within 6 months of study entry in the affected ear(s).

- Known or suspected allergy or hypersensitivity to quinolones or other ingredients
present in the medications to be used in the study.

- Patients who use ear plugs, head phones or ear buds and are unwilling to discontinue
their use during the study period.

- Other protocol-defined exclusion criteria may apply.