A phase II study on the duration and stability of the intraocular pressure-lowering effect and tolerability of Tafluprost compared with latanoprost.
OBJECTIVE
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.
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.
Carlo E
CE
Traverso
Auli
A
Ropo
Marina
M
Papadia
Hannu
H
Uusitalo
D004311:Double-Blind Method; D017889:Exfoliation Syndrome / Q000188:drug therapy / Q000503:physiopathology; D005123:Eye / Q000187:drug effects; D005260:Female; D005901:Glaucoma / Q000188:drug therapy* / Q000503:physiopathology*; D005902:Glaucoma, Open-Angle / Q000188:drug therapy / Q000503:physiopathology; D006801:Humans; D007429:Intraocular Pressure / Q000187:drug effects*; D000077338:Latanoprost; D008297:Male; D009798:Ocular Hypertension / Q000188:drug therapy* / Q000503:physiopathology*; D011460:Prostaglandins F / Q000009:adverse effects / Q000627:therapeutic use*; D011461:Prostaglandins F, Synthetic / Q000009:adverse effects / Q000627:therapeutic use*; D013997:Time Factors; D016896:Treatment Outcome; D055815:Young Adult
D011460:Prostaglandins F; D011461:Prostaglandins F, Synthetic; C485333:tafluprost; D000077338:Latanoprost