Buch John R, Martin Patricia, Xu Jie
Vision at Johnson & Johnson, USA.
Heliyon. 2024 Oct 30;10(21):e39995. doi: 10.1016/j.heliyon.2024.e39995. eCollection 2024 Nov 15.
To compare comfort outcomes between a novel daily disposable contact lens - designed to maximize comfort - and an established control. The hypothesis was that the test lens would be superior to the control for four key comfort questionnaire items: end-of-day comfort, all-day comfort, visual comfort while driving at night, and reduction of ocular fatigue from digital device use.
This randomized, controlled, subject-masked, parallel-arm study enrolled young (18-39 years), healthy, myopic, contact lens wearers with an up-to-date prescription at 19 investigational sites in the United States. Subjects wore either the test (ACUVUE® OASYS MAX 1-Day, senofilcon A) or control (Dailies Total1®, delefilcon A) lens for 2 weeks of bilateral, daily disposable wear before completing comfort questionnaire items, each of which had 5 or 6 response options. For each item, the odds ratio for positive (top-two-box) responses was estimated from a binomial generalized linear mixed model. A gatekeeping approach combined with the truncated Hochberg procedure was used for multiplicity adjustment.
Of 344 enrolled subjects, 342 subjects were randomized and dispensed lenses, with 171 subjects per lens group. Among the 342 subjects, 68.4% were female, 83.6% were White, and the average age was 29.7 (±5.53) years. The test lens was statistically superior to the control for all four comfort questions: odds ratios (test vs. control) were 2.01 (95% CI: 1.25, 3.22) for end-of-day comfort, 2.17 (alpha-adjusted CI: 1.30, 3.64) for all-day comfort, 2.00 (alpha-adjusted CI: 1.18, 3.41) for reducing ocular fatigue from digital device use, and 1.77 (95% CI: 1.04, 3.02) for comfortable vision while driving at night.
The test lens demonstrated statistically superior physical and visual comfort, as measured by the four comfort endpoints, compared to the control. The test lens had significantly greater odds of favorable responses for all comfort items compared to the control.
比较一种旨在最大化舒适度的新型日抛型隐形眼镜与一种既定对照产品在舒适度方面的结果。假设是，对于四个关键舒适度调查问卷项目，测试镜片在以下方面优于对照产品：一天结束时的舒适度、全天舒适度、夜间驾驶时的视觉舒适度以及使用数字设备导致的眼疲劳减轻情况。
这项随机、对照、受试者遮蔽、平行组研究在美国19个研究地点招募了年龄在18至39岁之间、健康、近视且有最新处方的隐形眼镜佩戴者。受试者佩戴测试镜片（ACUVUE® OASYS MAX 1-Day，senofilcon A）或对照镜片（Dailies Total1®，delefilcon A）进行为期2周的双侧日抛佩戴，然后完成舒适度调查问卷项目，每个项目有5或6个回答选项。对于每个项目，从二项式广义线性混合模型估计阳性（前两档）回答的比值比。采用守门法结合截断的霍奇伯格程序进行多重性调整。
在344名入组受试者中，342名受试者被随机分组并分发镜片，每个镜片组有171名受试者。在这342名受试者中，68.4%为女性，83.6%为白人，平均年龄为29.7（±5.53）岁。对于所有四个舒适度问题，测试镜片在统计学上优于对照产品：一天结束时舒适度的比值比（测试组与对照组）为2.01（95%置信区间：1.25，3.22），全天舒适度为2.17（α调整后置信区间：1.30，3.64），使用数字设备导致的眼疲劳减轻情况为2.00（α调整后置信区间：1.18，3.41），夜间驾驶时的舒适视觉为1.77（95%置信区间：1.04，3.02）。
与对照产品相比，通过四个舒适度终点指标衡量，测试镜片在物理和视觉舒适度方面在统计学上更优。与对照产品相比，测试镜片在所有舒适度项目上获得有利回答的几率显著更高。
