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Br J OphthalmolJuly 201887 citations

Preservatives in glaucoma medication.

Steven David W, Alaghband Pouya, Lim Kin Sheng


AI Summary

Despite known BAK toxicity, studies show no clear benefit of preservative-free glaucoma drops for all patients, but they are recommended for those with ocular surface disease or on multiple medications.

Abstract

Preservatives continue to be in widespread use in ophthalmic medications due to the convenience they provide, regulatory requirements and the higher cost of alternatives. Benzalkonium chloride (BAK) remains the most commonly used preservative but there is a trend towards the use of preservative-free (PF) drops for glaucoma, although at a higher price. An extensive body of literature explores BAK toxicity on ocular structures in animal and laboratory studies (in vitro and in vivo). Non-randomised controlled studies have provided some supporting evidence of its toxicity in patients, especially in those with pre-existing ocular surface disease (OSD) or on multiple medications. However, there have been very few randomised controlled trials that compare the same medication with and without BAK preservative. Several of these trials have never been published in any peer reviewed journals. Notwithstanding, those that have been published, have not demonstrated any clear benefits of the BAK-free formulations. Short duration and exclusion of those with OSD are limitations of these studies. There is a lack of evidence of clinically significant harm from a small number of BAK preserved drops in patients without OSD. This means that generally more expensive PF glaucoma medications should only be recommended for those on poly pharmacy or those with OSD but are not necessarily required for all patients.


MeSH Terms

Anterior Eye SegmentAntihypertensive AgentsGlaucomaHumansOphthalmic SolutionsPreservatives, Pharmaceutical

Key Concepts6

Published randomised controlled trials comparing glaucoma medication with and without benzalkonium chloride (BAK) preservative have not demonstrated any clear benefits of the BAK-free formulations, though these studies often have limitations such as short duration and exclusion of patients with ocular surface disease (OSD).

Comparative EffectivenessRCTRandomized Controlled Trialsn=Not specifiedCh28Ch29

There is a lack of evidence of clinically significant harm from a small number of benzalkonium chloride (BAK) preserved drops in patients without ocular surface disease (OSD).

TreatmentReviewn=Not applicableCh28Ch29

More expensive preservative-free (PF) glaucoma medications should only be recommended for patients on polypharmacy or those with ocular surface disease (OSD), and are not necessarily required for all glaucoma patients.

TreatmentExpert OpinionReviewn=Not applicableCh28Ch29

Benzalkonium chloride (BAK) remains the most commonly used preservative in ophthalmic medications for glaucoma, despite a trend towards preservative-free (PF) drops.

TreatmentReviewn=Not applicableCh28Ch29

An extensive body of literature from animal and laboratory studies (in vitro and in vivo) explores the toxicity of benzalkonium chloride (BAK) on ocular structures.

MechanismReviewn=Not applicableCh2Ch29

Non-randomised controlled studies have provided some supporting evidence of benzalkonium chloride (BAK) toxicity in patients, particularly in those with pre-existing ocular surface disease (OSD) or on multiple medications.

TreatmentCohortNon-randomised controlled studiesn=Not specifiedCh28Ch29

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