Suzuki Eye Clinic, Yamaguchi, Japan.
Santen Pharmaceutical Co., Ltd., Osaka, Japan.
Adv Ther. 2018 Jun;35(6):796-808. doi: 10.1007/s12325-018-0718-9. Epub 2018 Jun 5.
This was the first exploratory randomized controlled study to compare the efficacy and safety of a preserved tafluprost/timolol fixed combination (TAF/TIM) with a preserved latanoprost/timolol fixed combination (LAT/TIM).
This prospective, randomized, open-label study was conducted in Japanese patients with primary open-angle glaucoma, including normal-tension glaucoma or ocular hypertension. Following a 4-week LAT/TIM run-in period, eligible patients entered a 12-week treatment period, during which they received either LAT/TIM or TAF/TIM. The efficacy endpoint was the change in intraocular pressure (IOP) from baseline to week 12 and the safety endpoints included the changes from baseline to week 12 in superficial punctate keratopathy (SPK) score, tear breakup time (TBUT), and hyperemia score, as well as adverse events (AEs). At week 6, ocular symptoms were evaluated using a questionnaire.
In total, 131 patients provided informed consent. Of these, 115 completed the run-in period and were assigned to receive TAF/TIM (n = 60) or LAT/TIM (n = 55). At week 12, there were no significant differences between the TAF/TIM and LAT/TIM groups in the change from baseline in trough IOP and IOP at 4-6 h after instillation. There were no significant differences between the two groups in the change from baseline to week 12 in SPK score, TBUT, and hyperemia score. However, only in the TAF/TIM group, the total SPK score and the inferior cornea SPK score were significantly lower at week 12 compared with baseline. Eye irritation and eye pain were significantly decreased in the TAF/TIM group compared with the LAT/TIM group. Two treatment-related AEs were reported in the TAF/TIM group (3.3%) and none in the LAT/TIM group, while no serious AEs were reported in either group.
TAF/TIM is as effective as LAT/TIM in terms of IOP-reducing effect, with fewer ocular symptoms. TAF/TIM was associated with a significant improvement in SPK scores.
UMIN Clinical Trials Registry Identifier, UMIN000023862.
Santen Pharmaceutical Co., Ltd., Osaka, Japan.
这是第一项比较他氟前列素/噻吗洛尔固定组合（TAF/TIM）与拉坦前列素/噻吗洛尔固定组合（LAT/TIM）疗效和安全性的探索性随机对照研究。
这是一项前瞻性、随机、开放性研究，在日本原发性开角型青光眼患者中进行，包括正常眼压性青光眼或高眼压症患者。在为期 4 周的 LAT/TIM 导入期后，符合条件的患者进入为期 12 周的治疗期，在此期间他们接受 LAT/TIM 或 TAF/TIM 治疗。疗效终点是从基线到第 12 周的眼压（IOP）变化，安全性终点包括从基线到第 12 周的浅层点状角膜病变（SPK）评分、泪膜破裂时间（TBUT）和充血评分的变化，以及不良事件（AE）。在第 6 周时，使用问卷评估眼部症状。
共有 131 名患者提供了知情同意。其中，115 名患者完成了导入期并被分配接受 TAF/TIM（n=60）或 LAT/TIM（n=55）治疗。在第 12 周时，TAF/TIM 组和 LAT/TIM 组从基线到第 12 周的 IOP 谷值和滴注后 4-6 小时的 IOP 变化无显著差异。两组从基线到第 12 周的 SPK 评分、TBUT 和充血评分变化无显著差异。然而，只有在 TAF/TIM 组，第 12 周时总 SPK 评分和下角膜 SPK 评分较基线显著降低。与 LAT/TIM 组相比，TAF/TIM 组的眼部刺激和眼痛明显减少。TAF/TIM 组报告了 2 例与治疗相关的不良事件（3.3%），LAT/TIM 组无不良事件报告，两组均无严重不良事件报告。
TAF/TIM 在降低眼压方面与 LAT/TIM 疗效相当，眼部症状更少。TAF/TIM 与 SPK 评分的显著改善相关。
UMIN 临床研究注册中心注册号，UMIN000023862。
日本大阪三共制药有限公司。
