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 superiority of AL-60371 relative to Vehicle based on clinical cures at test-of-cure (TOC) for the treatment of acute otitis externa (AOE).

Timeline

Start

2012-04

Primary completion

2012-10

Completion

2012-10

Outcome

Met primary endpoint

paper clinical cure rate of 70.2% on day 11 (test of cure visit, ToC) compared to 36.6% in the vehicle group (P < .0001). PMID 42210509 ↗

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