Preservative-free tafluprost in the treatment of open-angle glaucoma or ocular hypertension in India: a phase III clinical trial.

Abstract

The aim of this study was to evaluate the efficacy and safety of preservative-free (PF) tafluprost compared with PF timolol in Indian subjects with open-angle glaucoma (OAG) or ocular hypertension. This was a randomised, multicentre, double-masked, phase III trial. Subjects aged 18-80years, following washout of current medication, with intraocular pressure (IOP) ≥24 and ≤36mmHg in at least one eye were randomised in a 1:1 ratio to 0.0015% PF tafluprost or 0.5% PF timolol for 4weeks. IOP was measured at 08:00, 10:00 and 16:00hours at baseline and at weeks 2 and 4. The primary efficacy end-point was the mean diurnal IOP change from baseline at week 4, and PF tafluprost was considered non-inferior to PF timolol if the upper bound of the 95% confidence interval (CI) for between-treatment differences was ≤1.5mmHg. The secondary end-point was the proportion of subjects with ≥25% reduction in IOP from baseline at week 4. In total, 190 subjects were randomised, 95 each, to PF tafluprost and PF timolol treatment. PF tafluprost was non-inferior to PF timolol with respect to diurnal IOP changes from baseline over 4weeks. The mean PF tafluprost-PF timolol difference in the diurnal IOP change was -1.7 (95% CI -2.6 to -0.7), suggestive of superiority for PF tafluprost. The secondary end-point was achieved in a higher proportion of PF tafluprost group subjects. Both PF tafluprost and PF timolol were well-tolerated with similar incidences of adverse events. PF tafluprost was safe and efficacious in reducing IOP in Indian subjects.