A phase II study on the duration and stability of the intraocular
pressure-lowering effect and tolerability of Tafluprost compared with
latanoprost.
Author(s): Traverso CE, Ropo A, Papadia M, Uusitalo H.
Affiliation(s): Centro di Ricerca Clinica e Laboratorio per il Glaucoma e la Cornea, DiNOG,
Clinica Oculistica University of Genova, Azienda Ospedaliera Universitaria San
Martino, Genova, Italy.
Publication date & source: 2010, J Ocul Pharmacol Ther. , 26(1):97-104
PURPOSE: Tafluprost is a novel prostaglandin F(2alpha)-receptor agonist shown to
lower intraocular pressure (IOP) in healthy humans and patients with elevated
IOP. We investigated the efficacy, safety, and tolerability of tafluprost 0.0015%
compared with latanoprost 0.005% in patients with primary open-angle glaucoma,
exfoliation glaucoma, or ocular hypertension.
METHODS: This was a randomized, double-masked, active-controlled, parallel-group,
multinational, and multicenter phase II study. Patients received either
tafluprost 0.0015% (n = 19) or latanoprost 0.005% (n = 19), both once daily. The
extent and duration of action of the IOP-lowering effects at Day 42 and Day 43
were the primary efficacy endpoints. Efficacy and safety parameters were analyzed
throughout.
RESULTS: Maximum IOP reduction was achieved by Day 7 and was sustained until Day
42 in both groups (mean [standard deviation] change from baseline -9.7 [3.3] mm
Hg for tafluprost and -8.8 [4.3] mm Hg for latanoprost). The overall treatment
group difference was 0.17 mm Hg (95% confidence interval -1.27 to 1.61; P =
0.811). The IOP-lowering effect was maintained for >or=24 h after the last dose
in both groups. Most adverse events were ocular and were similar in frequency and
severity between groups. There were 3 severe adverse events, all ocular, and all
in the tafluprost group (3/19 = 16%).
CONCLUSIONS: Tafluprost and latanoprost have comparable effects on the extent,
duration, and stability of IOP reduction, and are well tolerated in patients.
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