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

• Published in: International journal of clinical practice (Esher) Vol. 70; no. 7; pp. 577 - 586
• Main Authors: Chabi, A., Baranak, C., Lupinacci, R., Herring, W. J.
• Format: Journal Article
• Language: English
• Published: England Blackwell Publishing Ltd 01.07.2016; John Wiley & Sons, Inc
• Subjects: Antihypertensive Agents - therapeutic use; Confidence intervals; Double-Blind Method; Female; Glaucoma; Glaucoma, Open-Angle - drug therapy; Humans; Hypertension; India; Intraocular Pressure - drug effects; Male; Middle Aged; Ocular Hypertension - drug therapy; Prescription drugs; Prostaglandins F - adverse effects; Prostaglandins F - therapeutic use; Prostaglandins, Synthetic - therapeutic use; Timolol - adverse effects; Timolol - therapeutic use
• ISSN: 1368-5031; 1742-1241; 1742-1241
• DOI: 10.1111/ijcp.12815

Summary 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.