Lehfilcon A和Lotrafilcon B每日佩戴每月更换硅水凝胶多焦点隐形眼镜在老视患者中的临床表现和佩戴成功率的比较

摘要(中文译文)

比较和评估lehfilcon A与lotrafilcon B多焦点软性接触镜（MfSCLs）的临床性能和验配成功率。这是一项前瞻性、随机、双盲、交叉、发放临床研究。符合条件的佩戴者双眼验配并佩戴研究用MfSCLs（每天≥8小时，每周≥5天），持续30天。终点指标：第30天远距离（4 m）、中距离（80 cm）和近距离（40 cm）的双眼视力（VA）；验配成功率；第1次访视时眼保健专业人员（ECP）对研究发放镜片度数的评分；发放时和第30天的镜片验配及表面特征；安全性评估。共纳入101名受试者。第30天时，lehfilcon A MfSCLs在远、中、近距离VA方面非劣效于lotrafilcon B MfSCLs（非劣效界值：0.05；LSM差异的95% UCL为0.00、0.02、0.04；平均VA，lehfilcon A：-0.10 ± 0.08、-0.10 ± 0.08和0.01 ± 0.12；lotrafilcon B：-0.09 ± 0.07、-0.11 ± 0.08和-0.02 ± 0.11）。第1次访视时，两种MfSCLs中≥99.5%仅需每眼1-2片镜片即实现成功验配。ECP对验配便捷性的平均评分：lehfilcon A为9.8 ± 0.6；lotrafilcon B为9.7 ± 0.6。两种镜片均有约96.0%的受试者双眼球镜度数（D）相同，100.0%的受试者双眼ADD度数相同。所有MfSCLs均达到最佳/可接受验配。大多数MfSCLs（>96%）的前表面润湿性和前/后表面沉积物为0/1级。未报告严重不良事件（AEs），所有裂隙灯显微镜检查结果均为2级（轻度）或更低。Lehfilcon A多焦点接触镜在30天日常佩戴期间综合了出色的视觉性能、高验配成功率和稳定、舒适的佩戴体验。凭借其水梯度表面、良好的安全性特征和验配便捷性，它们是临床医生在为老视患者选择多焦点镜片时可以考虑的一种可靠且有益的选择。

Abstract

To compare and evaluate the clinical performance and fit success of lehfilcon A and lotrafilcon B multifocal soft contact lenses (MfSCLs). This was a prospective, randomized, double-masked, crossover, dispensing clinical study. Eligible wearers were fitted and wore study MfSCLs bilaterally (≥8 hours/day, ≥5 days/week) over 30 days. Endpoints: binocular visual acuity (VA) at distance (4 m), intermediate (80 cm), and near (40 cm) at day 30; fit rate success; eye care professional (ECP) rating, study dispensed lens power at visit 1; lens fit, and surface characteristics at dispense and day 30; safety assessments. Overall, 101 subjects were enrolled. At day 30, lehfilcon A MfSCLs were noninferior to lotrafilcon B MfSCLs for distance, intermediate, and near VA (non-inferiority margin: 0.05; 95% UCL of LSM difference 0.00, 0.02, 0.04; mean VA, lehfilcon A: -0.10 ± 0.08, -0.10 ± 0.08, and 0.01 ± 0.12; lotrafilcon B: -0.09 ± 0.07, -0.11 ± 0.08, and -0.02 ± 0.11). At visit 1, ≥99.5% of both MfSCLs achieved successful fit with 1-2 lenses/eye. Mean ECP ratings for ease of fit: lehfilcon A 9.8 ± 0.6; lotrafilcon B: 9.7 ± 0.6. About 96.0% of subjects had same sphere (D) power and 100.0% had same ADD power in both eyes for both lenses. All MfSCLs had optimal/acceptable fit. Majority of MfSCLs (>96%) had grade 0/1 front surface wettability and front/back surface deposits. No serious AEs were reported, and all biomicroscopy findings were graded 2 (mild) or lower. Lehfilcon A multifocal contact lenses combine excellent visual performance, high fit success, and a stable, comfortable wearing experience over 30 days of daily wear. With their water-gradient surface, favorable safety profile, and ease of fit, they represent a reliable and beneficial option for clinicians to consider when selecting multifocal lenses for presbyopic patients.

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