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

• Microbiological Success [ Time Frame: Day 11 ] [ Designated as safety issue: No ]
  Microbiological success is attained if all pre-therapy bacteria are absent from the exit specimen.
• Time to Cessation of Ear Pain [ Time Frame: Days ] [ Designated as safety issue: No ]
  Cessation of ear pain will be defined as occurring on the first time point that ear pain is absent (morning or evening) and does not return for all subsequent diary entries (as reported by the patient or parent/guardian).

The purpose of this study is to evaluate an investigational drug intended to treat acute otitis externa (AOE).

• Drug: AL-60371, 0.3% Otic Suspension
  Investigational otic suspension intended for the treatment of acute otitis externa
• Other: AL-60371 Vehicle
  Otic suspension with no active ingredients

• Experimental: AL-60371 0.3%
  Four drops, twice daily, to affected ear(s) for 7 days
  Intervention: Drug: AL-60371, 0.3% Otic Suspension
• Placebo Comparator: AL-60371 Vehicle
  Four drops, twice daily, to affected ear(s) for 7 days
  Intervention: Other: AL-60371 Vehicle

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.