JUL 30, 2012
This randomized, double-masked, multicenter trial found that preservative-free tafluprost was noninferior to preservative-free timolol over 12 weeks in terms of change from baseline IOP in patients with open-angle glaucoma (OAG) or ocular hypertension.
The authors randomized more than 600 patients with OAG or ocular hypertension to preservative-free tafluprost 0.0015% or preservative-free timolol 0.5%. IOP was measured three times daily (at 08:00, 10:00 and 16:00 hours) at baseline and at weeks two, six and 12.
The IOP-lowering effect of tafluprost was noninferior to timolol at all visits and time points over the 12-week treatment period. In addition, the upper boundary of the 95% CI was less than zero at four of nine time points, suggesting a numerical advantage for tafluprost.
Both treatments were generally well-tolerated. Adverse events were reported in about 20 percent of patients and the incidences were similar in both treatment groups. Few patients in either group discontinued treatment because of an adverse event, and relatively few adverse events were categorized as serious. As anticipated, ocular hyperemia occurred at a higher rate in the tafluprost group than the timolol group (4.4 percent vs. 1.2 percent).
The new prostaglandin analogue, tafluprost, appears to potentially offer advantages over other prostaglandin analogues. It may be better tolerated in patients with significant ocular surface disease and sensitivity to preservatives found in most ophthalmic drugs.