Randomized clinical trial of the efficacy and safety of preservative-free tafluprost and timolol in patients with open-angle glaucoma or ocular hypertension.
作者： Almira Chabi , Rohit Varma , James C. Tsai , Robert Lupinacci , Joseph Pigeon
DOI: 10.1016/J.AJO.2011.11.008
关键词:
摘要: Purpose To compare the efficacy and safety of tafluprost, a preservative-free (PF) prostaglandin analogue, with PF timolol in patients open-angle glaucoma or ocular hypertension. Design Randomized, double-masked, multicenter clinical trial. Methods After discontinuation washout existing hypotensive treatment, who had intraocular pressure (IOP) ≥23 ≤36 mm Hg at least 1 eye 08:00 hour time point were randomized 1:1 to 12 weeks treatment either tafluprost 0.0015% 0.5%. IOP was measured 3 times during day (08:00, 10:00, 16:00 hours) baseline 2, 6, 12. It hypothesized that would be noninferior over regard change from IOP. The trial powered for noninferiority margin 1.5 each 9 points assessed. Results A total 643 618 completed (PF tafluprost=306, timolol=312). IOPs assessed visit ranged 23.8 26.1 group 23.5 26.0 group. 12-week 17.4 18.6 17.9 18.5 timolol. At all points, upper limits 2-sided 95% confidence intervals difference between treatments lowering less than prespecified margin. Similar percentages reported pain/stinging/irritation (4.4% vs 4.6%) pruritus (2.5% 1.5%). reporting conjunctival hyperemia 4.4% 1.2% (nominal P = .016). Conclusions IOP-lowering effect is an efficacious generally well-tolerated agent.
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