Conditions: Acute Otitis Externa
Keywords: Acute Otitis Externa
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 768
Healthy volunteers: no

Brief 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).

Detailed description:
Patients were evaluated for safety and efficacy during the visits conducted at Day 3 (on-therapy), Day 8 (end-of-therapy), and Day 11 (TOC). Patients or parents/legal guardians completed a telephone diary twice daily to record assessments of ear pain, ear pain medication use, and the impact of ear pain on sleep and other daily activities.

Arms:
arm 1: AL-60371, 0.3% Otic Suspension, 4 drops to the affected ear(s) twice daily for 7 days arm 2: AL-60371 Vehicle, 4 drops to the affected ear(s) twice daily for 7 days

Interventions: intervention 1: AL-60371, 0.3% Otic Suspension intervention 2: AL-60371 Vehicle
Intervention descriptions: intervention 1: None intervention 2: Inactive ingredients used as a placebo comparator

Protocol document: