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

• Status: Completed
• Trial end date: 2013-05-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study was to demonstrate the superiority of AL-60371, 0.3% Otic Suspension relative to AL-60371 Vehicle based on clinical cures at test-of-cure (TOC) for the treatment of acute otitis externa (AOE).

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Alcon Research

Criteria

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.