Adjunctive Use of Tafluprost with Timolol Provides Additive Effects for Reduction of Intraocular Pressure in Patients with Glaucoma

Abstract

Purpose This study investigated the efficacy and safety of tafluprost as an adjunctive therapy to timolol in patients with open-angle glaucoma or ocular hypertension, uncontrolled by timolol monotherapy. Methods This was a randomized, double-masked, parallel-group, multinational and multicenter 12-week phase III study. Tafluprost 0.0015% (once daily: 20:10) or vehicle were administered as adjunctive therapy to timolol 0.5% (twice daily: 08:00 and 20:00) for 6 weeks, after which all patients received tafluprost for 6 weeks. Intraocular pressure (IOP) measurements were conducted at 08:00, 10:00, and 16:00 at baseline, and weeks 2, 4, 6, and 12. Results A total of 185 patients were randomized to tafluprost (n = 96) or vehicle (n = 89). Reductions in IOP were seen in both groups, which were consistently more pronounced with tafluprost. At week 6, the change from baseline in diurnal IOP ranged from −5.49 to −5.82 mm Hg, and the overall treatment difference (tafluprost vehicle) was −1.49 mmHg (upper 95% confidence interval, −0.66; p<0.001, intention-to-treat population, repeated measurements of the analysis of covariance model). At week 12, the change from baseline ranged from −6.22 to −6.79 mmHg in the tafluprost group. Patients switched from vehicle to tafluprost achieved a similar decrease in IOP to those who received tafluprost throughout the study (group difference at 12 weeks, −0.09 mmHg, p=0.812). There were more ocular adverse events with tafluprost compared with vehicle (42% vs. 29%, respectively), but most were mild in severity. Conclusions As adjunctive therapy to timolol, tafluprost achieved a consistently greater reduction in IOP compared with vehicle, and was well tolerated.