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

David F Garway-Heath, Prof David P Crabb, Catey Bunce, Gerassimos Lascaratos, Francesca Amalfitano, Nitin Anand, Prof Augusto Azuara-Blanco, Prof Rupert R Bourne, David C Broadway, Ian A Cunliffe, Jeremy P Diamond, Scott G Fraser, Tuan A Ho, Prof Keith R Martin, Andrew I McNaught, Anil Negi, Krishna Patel, Richard A Russell, Ameet Shah, Paul G SpryKatsuyoshi Suzuki, Edward T White, Richard P Wormald, Wen Xing, Prof Thierry G Zeyen

Research output: Contribution to journalArticlepeer-review

260 Citations (Scopus)

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
Original languageEnglish
Pages (from-to)1295-1304
Number of pages11
JournalLancet
Volume385
Issue number9975
Early online date19 Dec 2014
DOIs
Publication statusPublished - 04 Apr 2015

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