Comfort advantages demonstrated with a novel soft contact lens: A randomized clinical trial.

Purpose: 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.

Methods: 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.

Results: 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.

Conclusion: 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.