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

Phase 3 Completed 768 enrolled Alcon Research

RandomizedParallel-groupDouble-blindTreatment

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

Outcome

Met primary endpoint

paper finafloxacin had a 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

Evaluation	Drug	Modality	Dose	Route
Subject	Finafloxacin	Small molecule	0.3 %	Topical