Tear film dynamics of a new soft contact lens

Abstract

PurposeTo 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.MethodsThis 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).ResultsOf 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.ConclusionThe 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.