NCT01535599

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 768 (actual)
• Sponsor: Alcon Research · Industry
• Sex: All
• Age: 6 Months
• Healthy volunteers: Not accepted

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.

Conditions

• Acute Otitis Externa

Interventions

Type	Name	Description
DRUG	AL-60371, 0.3% Otic Suspension
OTHER	AL-60371 Vehicle	Inactive ingredients used as a placebo comparator

Timeline

• Start date: 2012-03-01
• Primary completion: 2013-05-01
• Completion: 2013-05-01
• First posted: 2012-02-20
• Last updated: 2014-07-08
• Results posted: 2014-06-18