Jerkins Gary, Greiner Jack V, Tong Louis, Tan Jacqueline, Tauber Joseph, Mearza Ali, Srinivasan Sruthi
Advancing Vision Research, LLC, Nashville, TN, USA.
Clinical Eye Research of Boston, Boston, MA, USA.
Clin Ophthalmol. 2020 Jun 18;14:1665-1673. doi: 10.2147/OPTH.S256351. eCollection 2020.
The aim of this study was to compare the efficacy of two lipid-based lubricant eye drops in patients with lipid-deficient dry eye.
This Phase IV, multicenter, prospective, double-masked study enrolled adults (aged ≥18 years) who had a tear film breakup time (TFBUT) of ≤15 seconds(s), and unanesthetized Schirmer I test of ≥3 mm to ≤12 mm in at least one eye, at both screening and baseline visits. Eligible patients (n=231) were randomized (1:1) and received either Systane Balance (SYSB; n=117) or Refresh Optive Advanced (RFO-Ad, n=114), four-times a day, for 35 days. The primary endpoint was non-inferiority for change from baseline in TFBUT at Day 35 (non-inferiority was established if the lower limit of the 95% confidence interval (CI) for the difference between the treatment groups was > -1.0 s); secondary endpoints (test of superiority) were change in TFBUT and global ocular discomfort visual analog scale (VAS) score at Day 35. Other endpoints included the impact of dry eye on everyday life (IDEEL) treatment satisfaction scores (inconvenience and effectiveness) and safety.
At Day 35, the mean change from baseline in TFBUT was 0.998 s in the SYSB and 0.868 s in the RFO-Ad groups with a treatment difference: 0.130 s; (95% CI -0.34, 0.60; <0.0001) demonstrating non-inferiority of SYSB to RFO-Ad. The global ocular discomfort VAS scores improved in both groups, with a mean change from baseline of -9.7 and -8.8 in SYSB and RFO-Ad groups (treatment difference -0.8; =0.62), respectively. No meaningful difference was observed in IDEEL treatment effectiveness and treatment inconvenience scores between SYSB vs RFO-Ad (>0.05 for treatment difference). Both treatments were well tolerated.
SYSB lubricant eye drops were non-inferior to RFO-Ad for improvement in TFBUT in patients with lipid-deficient dry eye. Both lubricant eye drops improved TFBUT and ocular discomfort scores in patients with lipid-deficient dry eye.
本研究旨在比较两种脂质基润滑眼药水对脂质缺乏型干眼症患者的疗效。
这项IV期、多中心、前瞻性、双盲研究纳入了年龄≥18岁的成年人，这些患者在筛选和基线访视时，泪膜破裂时间（TFBUT）≤15秒，且至少一只眼睛的未麻醉Schirmer I试验结果为≥3毫米至≤12毫米。符合条件的患者（n = 231）被随机分为两组（1:1），分别接受思然倍润（SYSB；n = 117）或瑞珠新视界（RFO-Ad，n = 114），每天滴眼4次，持续35天。主要终点是第35天时TFBUT相对于基线的变化的非劣效性（如果治疗组之间差异的95%置信区间（CI）下限> -1.0秒，则确定为非劣效）；次要终点（优效性检验）是第35天时TFBUT的变化和整体眼部不适视觉模拟量表（VAS）评分。其他终点包括干眼症对日常生活的影响（IDEEL）治疗满意度评分（不便程度和有效性）以及安全性。
在第35天时，SYSB组TFBUT相对于基线的平均变化为0.998秒，RFO-Ad组为0.868秒，治疗差异为0.130秒；（95%CI -0.34，0.60；<0.0001），表明SYSB相对于RFO-Ad具有非劣效性。两组的整体眼部不适VAS评分均有所改善，SYSB组和RFO-Ad组相对于基线的平均变化分别为-9.7和-8.8（治疗差异-0.8；P = 0.62）。在SYSB和RFO-Ad之间，IDEEL治疗有效性和治疗不便程度评分未观察到有意义的差异（治疗差异>0.05）。两种治疗的耐受性均良好。
在改善脂质缺乏型干眼症患者的TFBUT方面，SYSB润滑眼药水不劣于RFO-Ad。两种润滑眼药水均改善了脂质缺乏型干眼症患者的TFBUT和眼部不适评分。
