Purpose: The objective of the study was to compare the long-term efficacy and safety of tafluprost 0.0015% with latanoprost 0.005% eye drops in patients with open-angle glaucoma or ocular hypertension.
Methods: This double-masked, active-controlled, parallel-group, multinational, multicentre, phase III study was conducted at 49 centres in 8 countries. Eligible patients were assigned to treatment administered once daily at 20:00 hrs for up to 24 months. Change from baseline intraocular pressure (IOP) was the primary efficacy variable. Adverse events were recorded and ocular safety was evaluated. Both tafluprost and latanoprost were preserved with benzalkonium chloride.
Results: From 533 patients randomized, 402 patients completed 24 months of therapy. Both treatments had a substantial IOP-lowering effect which persisted throughout the study (-7.1 mmHg for tafluprost and -7.7 mmHg for latanoprost at 24 months). Although the IOP-lowering effect during the study was slightly larger with latanoprost, this difference was clinically small and the noninferiority of tafluprost to latanoprost over all diurnal IOP measurements was shown with anova and almost reached with ancova (upper limits of the 95% confidence intervals 1.38 and 1.52 for the overall period, respectively). The noninferiority limit was 1.5 mmHg.
Conclusions: Tafluprost is a new effective and well-tolerated treatment for glaucoma and ocular hypertension.