Polihexanide (PHMB) Eye Drops in Patients Affected by Acanthamoeba Keratitis

Summary

Prospective randomized study to evaluate the efficacy, safety and tolerability of 0.08% polihexanide (PHMB) eye drops in patients affected by acanthamoeba keratitis. 130 subjects were assigned to one of the following 2 treatment groups: Group 1: 0.08% polihexanide (PHMB) + placebo Group 2: 0.02% polihexanide (PHMB) + 0.1% propamidine

Timeline

Start

2017-08-13

Primary completion

2021-06-30

Completion

2022-03-30

Publications

• Background Papa V, Rama P, Radford C, Minassian DC, Dart JKG. Acanthamoeba keratitis therapy: time to cure and visual outcome analysis for different antiamoebic therapies in 227 cases. Br J Ophthalmol. 2020 Apr;104(4):575-581. doi: 10.1136/bjophthalmol-2019-314485. Epub 2019 Aug 10.
• Background Papa V, van der Meulen I, Rottey S, Sallet G, Overweel J, Asero N, Minassian DC, Dart JKG. Safety and tolerability of topical polyhexamethylene biguanide: a randomised clinical trial in healthy adult volunteers. Br J Ophthalmol. 2022 Feb;106(2):190-196. doi: 10.1136/bjophthalmol-2020-317848. Epub 2020 Nov 25.
• Dart JKG, Papa V, Rama P, Knutsson KA, Ahmad S, Hau S, Sanchez S, Franch A, Birattari F, Leon P, Fasolo A, Kominek EM, Jadczyk-Sorek K, Carley F, Hossain P, Minassian DC. The Orphan Drug for Acanthamoeba Keratitis (ODAK) Trial: PHMB 0.08% (Polihexanide) and Placebo versus PHMB 0.02% and Propamidine 0.1. Ophthalmology. 2024 Mar;131(3):277-287. doi: 10.1016/j.ophtha.2023.09.031. Epub 2023 Oct 5.

Drugs

Indications