Glaucoma Unit, 1st University Department of Ophthalmology, Aristotle University, AHEPA Hospital, , Thessaloniki, Greece.
Br J Ophthalmol. 2013 Dec;97(12):1510-5. doi: 10.1136/bjophthalmol-2012-303026. Epub 2013 May 16.
To compare 24 h intraocular pressure (IOP) control obtained with preservative free (PF) tafluprost 0.0015% versus branded preservative containing latanoprost 0.005% administered as first choice monotherapy in patients with primary open angle glaucoma (POAG) or ocular hypertension (OHT).
This prospective, observer-masked, crossover study included consecutive newly diagnosed patients with POAG or OHT, and baseline IOP between 24 and 33 mm Hg. Qualifying patients underwent baseline untreated 24 h IOP monitoring in habitual positions, with Goldmann tonometry at times 10:00, 14:00, 18:00 and 22:00, and Perkins supine tonometry at times 02:00 and 06:00. They were then randomised to either latanoprost or tafluprost, administered in the evening, for 3 months and then switched to the opposite therapy for another 3 months. 24 h monitoring was repeated at the end of each treatment period.
38 patients completed the study. Mean untreated 24 h IOP (24.9 mm Hg) was significantly reduced with both prostaglandins (p<0.001). Tafluprost demonstrated similar mean 24 h efficacy compared with latanoprost (17.8 vs 17.7 mm Hg; p=0.417). Latanoprost demonstrated significantly better 24 h trough IOP (15.9 vs 16.3 mm Hg; p=0.041) whereas tafluprost provided significantly lower 24 h IOP fluctuation (3.2 vs 3.8 mm Hg; p=0.008). No significant difference existed between the two prostaglandins for any adverse event.
PF tafluprost achieved similar 24 h IOP reduction to branded latanoprost. The current study highlights the importance of complete assessment of efficacy over 24 h.
NCT01162603.
比较无防腐剂(PF)他氟前列素 0.0015%与含防腐剂的品牌拉坦前列素 0.005%在原发性开角型青光眼(POAG)或高眼压症(OHT)患者中作为一线单药治疗时 24 小时眼压(IOP)的控制情况。
这是一项前瞻性、观察者设盲、交叉研究,纳入了新诊断的 POAG 或 OHT 患者,基线 IOP 在 24 至 33mmHg 之间。符合条件的患者在惯常体位下进行未经治疗的基线 24 小时 IOP 监测,10:00、14:00、18:00 和 22:00 点用 Goldmann 眼压计测量,02:00 和 06:00 点用 Perkins 仰卧眼压计测量。然后将他们随机分为拉坦前列素或他氟前列素组,晚上给药,治疗 3 个月,然后再转换为另一种治疗方案治疗 3 个月。在每个治疗期末重复 24 小时监测。
38 例患者完成了研究。两种前列腺素均显著降低了未经治疗的 24 小时平均 IOP(24.9mmHg)(p<0.001)。他氟前列素与拉坦前列素的 24 小时平均疗效相似(17.8 与 17.7mmHg;p=0.417)。拉坦前列素的 24 小时谷值 IOP 明显更好(15.9 与 16.3mmHg;p=0.041),而他氟前列素的 24 小时 IOP 波动明显更低(3.2 与 3.8mmHg;p=0.008)。两种前列腺素在任何不良事件方面均无显著差异。
PF 他氟前列素达到了与品牌拉坦前列素相似的 24 小时 IOP 降低效果。本研究强调了对 24 小时内疗效进行全面评估的重要性。
NCT01162603。