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Abstract #69143 Published in IGR 18-1
Preservative-free tafluprost in the treatment of open-angle glaucoma or ocular hypertension in India: a phase III clinical trial
Chabi A; Baranak C; Lupinacci R; Herring WJInternational Journal of Clinical Pract 2016; 70: 577-586
AIM: 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. METHODS: This was a randomised, multicentre, double-masked, phase III trial. Subjects aged 18-80 years, following washout of current medication, with intraocular pressure (IOP) ≥ 24 and ≤ 36 mmHg in at least one eye were randomised in a 1:1 ratio to 0.0015% PF tafluprost or 0.5% PF timolol for 4 weeks. IOP was measured at 08:00, 10:00 and 16:00 hours 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 ≤ 1.5 mmHg. The secondary end-point was the proportion of subjects with ≥ 25% reduction in IOP from baseline at week 4. RESULTS: 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 4 weeks. 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. CONCLUSIONS: PF tafluprost was safe and efficacious in reducing IOP in Indian subjects.
Merck & Co., Inc., Kenilworth, NJ, USA.
Full articleClassification:
11.16 Vehicles, delivery systems, pharmacokinetics, formulation (Part of: 11 Medical treatment)
11.4 Prostaglandins (Part of: 11 Medical treatment)
9.2.1 Ocular hypertension (Part of: 9 Clinical forms of glaucomas > 9.2 Primary open angle glaucomas)
