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

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).

Timeline

Start

2012-03

Primary completion

2013-05

Completion

2013-05

Publications

• Edmunds A, Bentley C, Luckermann M, Voet B, Vente A. Efficacy and Safety of Finafloxacin Otic Suspension, 0.3% for the Treatment of Acute Otitis Externa: Results from two Phase III Randomized Clinical Studies. Ann Otol Rhinol Laryngol. 2026 May 28:34894261453726. doi: 10.1177/00034894261453726. Online ahead of print.

Drugs

Indications