Mizoue Shiro, Nakano Tadashi, Fuse Nobuo, Iwase Aiko, Matsumoto Shun, Yoshikawa Keiji
Department of Ophthalmology, Ehime University Graduate School of Medicine, Ehime, Japan.
Department of Ophthalmology, Jikei University School of Medicine, Tokyo, Japan.
Clin Ophthalmol. 2014 Feb 3;8:347-54. doi: 10.2147/OPTH.S57640. eCollection 2014.
This study aimed to evaluate the effect of travoprost with sofZia® preservative system for lowering the intraocular pressure (IOP) of Japanese normal tension glaucoma (NTG) patients.
In this prospective, multicenter, open-label study, Japanese NTG patients with baseline IOPs <20 mmHg were enrolled after three consecutive time measurements taken at screening and baseline visits. Travoprost with sofZia® was instilled once daily. Lowering effect on IOP, conjunctival hyperemia, superficial punctate keratopathy, and adverse events were examined at week 4, 8, and 12 after drug instillation.
One-hundred and three of the 107 enrolled patients (baseline IOP =15.2±2.0 mmHg [mean ± standard deviation]) completed the study. The mean IOP value as well as percent reduction was significantly reduced at each visit after travoprost with sofZia® initiation (P<0.0001). The conjunctival hyperemia score was 1 or less throughout the study, though it increased significantly over time. No significant change was observed in superficial punctate keratopathy. The cumulative incidence of side effects such as eyelash changes, eyelid pigmentation, and deepening of the upper lid was 47.6%, 27.2%, and 16.5%, respectively.
Travoprost preserved with sofZia® effectively lowered the IOP of Japanese NTG patients. It was well tolerated with few discontinuations due to adverse events.
本研究旨在评估含sofZia®防腐剂系统的曲伏前列素对降低日本正常眼压性青光眼(NTG)患者眼压的效果。
在这项前瞻性、多中心、开放标签研究中,筛选和基线访视时连续三次测量基线眼压<20 mmHg的日本NTG患者被纳入。含sofZia®的曲伏前列素每日滴注一次。在滴注药物后的第4、8和12周检查对眼压的降低效果、结膜充血、浅层点状角膜炎和不良事件。
107名入组患者中的103名(基线眼压=15.2±2.0 mmHg[平均值±标准差])完成了研究。开始使用含sofZia®的曲伏前列素后,每次访视时的平均眼压值以及降低百分比均显著降低(P<0.0001)。在整个研究过程中,结膜充血评分≤1,尽管随时间显著增加。浅层点状角膜炎未观察到显著变化。睫毛改变、眼睑色素沉着和上睑加深等副作用的累积发生率分别为47.6%、27.2%和16.5%。
含sofZia®保存的曲伏前列素可有效降低日本NTG患者的眼压。耐受性良好,因不良事件停药的情况很少。