Latanoprost for open-angle glaucoma (UKGTS): a randomised, multicentre, placebo-controlled trial

Garway-Heath, David F. and Crabb, David P. and Bunce, Catey and Lascaratos, Gerassimos and Amalfitano, Francesca and Anand, Nitin and Azuara-Blanco, Augusto and Bourne, Rupert R. A. and Broadway, David C. and Cunliffe, Ian A. and Diamond, Jeremy P. and Fraser, Scott G. and Ho, Tuan A. and Martin, Keith R. and McNaught, Andrew I. and Negi, Anil and Patel, Krishna and Russell, Richard A. and Shah, Ameet and Spry, Paul G. and Suzuki, Katsuyoshi and White, Edward T. and Wormald, Richard P. and Xing, Wen and Zeyen, Thierry G. (2015) Latanoprost for open-angle glaucoma (UKGTS): a randomised, multicentre, placebo-controlled trial. The Lancet, 385 (9975). pp. 1295-1304. ISSN 1474-547X

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Official URL: https://doi.org/10.1016/S0140-6736(14)62111-5

Abstract

Background: Treatments for open-angle glaucoma aim to prevent vision loss through lowering of intraocular pressure, but to our knowledge no placebo-controlled trials have assessed visual function preservation, and the observation periods of previous (unmasked) trials have typically been at least 5 years. We assessed vision preservation in patients given latanoprost compared with those given placebo. Methods: In this randomised, triple-masked, placebo-controlled trial, we enrolled patients with newly diagnosed open-angle glaucoma at ten UK centres (tertiary referral centres, teaching hospitals, and district general hospitals). Eligible patients were randomly allocated (1:1) with a website-generated randomisation schedule, stratified by centre and with a permuted block design, to receive either latanoprost 0·005% (intervention group) or placebo (control group) eye drops. Drops were administered from identical bottles, once a day, to both eyes. The primary outcome was time to visual field deterioration within 24 months. Analyses were done in all individuals with follow-up data. The Data and Safety Monitoring Committee (DSMC) recommended stopping the trial on Jan 6, 2011 (last patient visit July, 2011), after an interim analysis, and suggested a change in primary outcome from the difference in proportions of patients with incident progression between groups to time to visual field deterioration within 24 months. This trial is registered, number ISRCTN96423140. Findings: We enrolled 516 individuals between Dec 1, 2006, and March 16, 2010. Baseline mean intraocular pressure was 19·6 mm Hg (SD 4·6) in 258 patients in the latanoprost group and 20·1 mm Hg (4·8) in 258 controls. At 24 months, mean reduction in intraocular pressure was 3·8 mm Hg (4·0) in 231 patients assessed in the latanoprost group and 0·9 mm Hg (3·8) in 230 patients assessed in the placebo group. Visual field preservation was significantly longer in the latanoprost group than in the placebo group: adjusted hazard ratio (HR) 0·44 (95% CI 0·28–0·69; p=0·0003). We noted 18 serious adverse events, none attributable to the study drug. Interpretation: This is the first randomised placebo-controlled trial to show preservation of the visual field with an intraocular-pressure-lowering drug in patients with open-angle glaucoma. The study design enabled significant differences in vision to be assessed in a relatively short observation period.

Item Type: Journal Article
Faculty: ARCHIVED Faculty of Health, Social Care & Education (until September 2018)
Depositing User: Lisa Blanshard
Date Deposited: 07 Feb 2020 16:16
Last Modified: 07 Feb 2020 16:16
URI: http://arro.anglia.ac.uk/id/eprint/705170

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