Tear film dynamics of a new soft contact lens.

Abstract

To present the objective metrics from a study that evaluated the clinical performance of a senofilcon A contact lens, both with and without a new manufacturing technique. This was a single-site, five-visit, controlled, randomised, subject-masked, 2 × 2 crossover study (May-August 2021) with a 2-week lens dispensing period (bilateral wear) and weekly follow-up visits. Healthy adult (18-39 years), habitual spherical silicone hydrogel contact lens wearers were included. The High-definition (HD) Analyzer™ was used to objectively measure the lens-on-eye optical system resulting from the study lenses at 1-week follow-up. Measurements assessed were vision break-up time (VBUT), modulation transfer function (MTF) cutoff, Strehl ratio (SR), potential visual acuity (PVA) for 100% contrast and objective scatter index (OSI). Of the 50 enrolled participants, 47 (94.0%) were randomly assigned to one of the two possible lens wear sequences (test/control or control/test) and dispensed at least one study lens. The estimated odds ratio of VBUT > 10 s was 1.582 (95% confidence interval [CI]: 1.009 to 2.482) in test versus control lens. The least squares mean difference estimates of MTF cutoff, SR and PVA for 100% contrast between test versus control lens were 2.243 (95% CI: 0.012 to 4.475), 0.011 (95% CI: -0.002 to 0.023) and 0.073 (95% CI: -0.001 to 0.147), respectively. The estimated ratio of median OSI between test versus control lens was 0.887 (95% CI: 0.727 to 1.081). The test lens demonstrated superiority over the control lens with respect to VBUT and MTF cutoff. No serious adverse events were reported; eight adverse events (three ocular, five non-ocular) were indicated by six participants during the study. The test lens demonstrated an increased probability of having a longer VBUT (>10 s). Future studies may be designed to assess the efficacy and long-term use of the test lens in a larger population.