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.
J Ocul Pharmacol Ther. 2010 Feb;26(1):97-104. doi: 10.1089/jop.2009.0066.
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.
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.
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%).
Tafluprost and latanoprost have comparable effects on the extent, duration, and stability of IOP reduction, and are well tolerated in patients.
他氟前列素是一种新型前列腺素 F（2α）-受体激动剂，已被证明可降低健康人群和高眼压患者的眼内压（IOP）。我们研究了他氟前列素 0.0015%与拉坦前列素 0.005%在原发性开角型青光眼、剥脱性青光眼或高眼压症患者中的疗效、安全性和耐受性。
这是一项随机、双盲、阳性对照、平行分组、多国和多中心的 II 期研究。患者接受他氟前列素 0.0015%（n=19）或拉坦前列素 0.005%（n=19），每日一次。第 42 天和第 43 天 IOP 降低作用的程度和持续时间是主要的疗效终点。整个研究过程中分析了疗效和安全性参数。
两组患者在第 7 天达到最大 IOP 降低，并持续至第 42 天（他氟前列素组和拉坦前列素组从基线的平均（标准差）变化分别为-9.7[3.3]mmHg 和-8.8[4.3]mmHg）。总的治疗组差异为 0.17mmHg（95%置信区间-1.27 至 1.61；P=0.811）。两组患者在最后一次给药后 >24 小时内 IOP 降低作用均得到维持。大多数不良事件为眼部，且两组的发生频率和严重程度相似。有 3 例严重不良事件，均为眼部，均发生在他氟前列素组（3/19=16%）。
他氟前列素和拉坦前列素在 IOP 降低的程度、持续时间和稳定性方面具有相似的作用，且在患者中具有良好的耐受性。
