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Abstract #25828 Published in IGR 12-2
A phase II study on the duration and stability of the intraocular pressure-lowering effect and tolerability of tafluprost compared with latanoprost
Traverso CE; Ropo A; Papadia M; Uusitalo HJournal of Ocular Pharmacology and Therapeutics 2010; 26: 97-104
See also comment(s) by Shan Lin •
Purpose: Tafluprost is a novel prostaglandin F(2)-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 (greater-than or equal to)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.
C. E. Traverso. Centro di Ricerca Clinica e Laboratorio per Il Glaucoma e la Cornea, University of Genova, Azienda Ospedaliera Universitaria San Martino, Largo R. Benzi Genova 10-16132, Italy. mc8620@mclink.it
Classification:
11.14 Investigational drugs; pharmacological experiments (Part of: 11 Medical treatment)
11.4 Prostaglandins (Part of: 11 Medical treatment)