Latanoprost for XXXX (UKGTS): a randomised, multicentre, placebo-controlled trial.

@entity1018 @entity1 @entity227 @entity1538 @entity34536
BACKGROUND: Treatments for @entity1538 aim to prevent @entity1018 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 @entity1 given latanoprost compared with those given placebo. METHODS: In this randomised, triple-masked, placebo-controlled trial, we enrolled @entity1 with newly diagnosed @entity1538 at ten UK centres (tertiary referral centres, teaching hospitals, and district general hospitals). Eligible @entity1 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 @entity227 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 @entity1 visit July, 2011), after an interim analysis, and suggested a change in primary outcome from the difference in proportions of @entity1 with incident progression between groups to time to @entity227 within 24 months. This trial is registered, number ISRCTN96423140. FINDINGS: We enrolled 516 individuals between @entity34536 , 2006, and March 16, 2010. Baseline mean intraocular pressure was 19  6 mm Hg (SD 4  6) in 258 @entity1 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 @entity1 assessed in the latanoprost group and 0  9 mm Hg (3  8) in 230 @entity1 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 @entity1 with @entity1538 . The study design enabled significant differences in vision to be assessed in a relatively short observation period. FUNDING: Pfizer, UK National Institute for Health Research Biomedical Research Centre.
