Conditions: Acute Otitis Externa
Keywords: Acute otitis externa
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 589
Healthy volunteers: no

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

Detailed description:
Participants or legal guardians completed a telephone diary twice daily to record assessments of ear pain, ear medication use, and impact of ear pain on sleep and other daily activities.

Arms:
arm 1: AL-60371, 0.3% otic suspension, 4 drops in the affected ear(s) twice daily for 7 days arm 2: AL-60371 Vehicle, 4 drops in 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: Investigational otic suspension intended for the treatment of acute otitis externa intervention 2: Inactive ingredients used as placebo

Protocol document: