Preservative-free tafluprost in the treatment of open-angle glaucoma or ocular hypertension in India: a phase III clinical trial.
OBJECTIVE
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.
A
A
Chabi
Merck & Co., Inc., Kenilworth, NJ, USA.
C
C
Baranak
Merck & Co., Inc., Kenilworth, NJ, USA.
R
R
Lupinacci
Merck & Co., Inc., Kenilworth, NJ, USA.
W J
WJ
Herring
D000959:Antihypertensive Agents / Q000627:therapeutic use; D004311:Double-Blind Method; D005260:Female; D005902:Glaucoma, Open-Angle / Q000188:drug therapy*; D006801:Humans; D007194:India; D007429:Intraocular Pressure / Q000187:drug effects; D008297:Male; D008875:Middle Aged; D009798:Ocular Hypertension / Q000188:drug therapy*; D011460:Prostaglandins F / Q000009:adverse effects / Q000627:therapeutic use*; D011465:Prostaglandins, Synthetic / Q000627:therapeutic use*; D013999:Timolol / Q000009:adverse effects / Q000627:therapeutic use
D000959:Antihypertensive Agents; D011460:Prostaglandins F; D011465:Prostaglandins, Synthetic; C485333:tafluprost; D013999:Timolol