To compare the effects of a photochromic contact lens vs. a non-photochromic control lens on visual function. Methods: A subject-masked, prospective contralateral eye design was used. Sixty-one subjects were enroled based on age (using a 2:1 allocation ratio for ages 18-39 and 40-65 years, respectively). The study lenses were senofilcon A with photochromic additive (Test) that filtered over the entire lens, compared to a non-photochromic Control with no tint. The Test lens was partially activated during testing with a steady-state transmittance of approximately 62%. Eligible subjects were tested using both study lenses, with Test and Control lens randomized by eye. Five visual function outcomes were tested: photostress recovery (PSR), glare disability (GD), glare discomfort (GDC), chromatic contrast (CC) and vernier acuity (VA). Iris colour and macular pigment density were assessed as control variables. PSR was measured as the time needed to recover sight of a target after an intense xenon flash exposure; GD was evaluated as the energy needed to veil a central target by a surrounding xenon annulus; GDC was measured using bio-imaging of the squint response and by self-report using a 9-item Likert scale; CC was measured as thresholds for a yellow grating target superposed on a 460-nm background; VA was determined by measuring vernier offsets of light lines through apertures. Results: Based on our stimulus conditions, PSR was 43% faster using the Test vs. the Control. The eye wearing the Test had 38% less squint (GDC) compared to the Control. GD was improved by 36% in the Test vs. Control and CC was enhanced by 48% with the Test. There was no significant difference in VA. Conclusions: There was a beneficial influence on visual function when comparing the photochromic with the non-photochromic contact lens. This benefit was seen specifically with respect to PRT, GDC, GD and CC thresholds.

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Purpose To assess the visual effects of wearing both an activated and an inactivated photochromic contact lens, with a direct comparison to a non-photochromic contact lens worn in the fellow eye. This study focused on the visual effects of scatter quantified as the minimum distance between two points of light, and the diameter of the halo and starbursts that surround a bright white point source. Methods 60 subjects (aged 18–65 years) were measured in a contralateral design where lens type was randomly assigned, one type to each eye. During activated testing, all visual measures of both study lenses were made while each eye was illuminated by a violet ( λ max = 365, half bandwidth 20 nm) activator, which caused steady-state activation of the photochromic lens during the period of testing. Two-point thresholds were determined by measuring the minimum distance between two points of broadband xenon light. Glare geometry was measured using an aperture (∼4 mm) that created a bright point source of light 45 inches from the plane of the eye. Between the point source and subject, a centering precision caliper was used to measure lateral spread of halos (diffusion around the source) and visual spokes. The head was stabilized using an adjustable head-rest assembly and the eye was aligned and monitored with a bore camera. Results Compared to the non-photochromic lens, and based on the stimulus conditions used in these measurements, the activated and inactivated photochromic lens reduced the light spread using the two-point threshold technique by 32% and 19% respectively; the diameter of the halos were reduced by 44% and 16% respectively; and the spokes were narrowed by 39% and 20% respectively. Based on 95% confidence interval testing, these effects were all statistically significant ( p < 0.05). Conclusions These results are consistent with previous data showing that soft contact lenses with a photochromic additive can improve many aspects of visual function, consistent with their level or activation. Our past data focused on visual function under bright light conditions (e.g., glare disability, discomfort, photostress recovery and chromatic contrast) with an activated photochromic. In this study, we found differences even in the inactivated state, using less intense stimuli (10 cd/m 2 at the source). This suggests that the photochromic lens improves the effects of light scatter even at lower luminance.

SIGNIFICANCE The first contact lens to incorporate a photochromic additive was cleared by the U.S. Food and Drug Administration last year. Because any ophthalmic lens that absorbs visible wavelengths will reduce retinal illuminance, it is important to understand the impact of this new photochromic contact lens on vision and both daytime and nighttime driving performance. PURPOSE The purpose of this study was to evaluate the effect of senofilcon A photochromic contact lens wear on vision and driving performance under real-world conditions by comparison with a nonphotochromic contact lens and plano photochromic spectacles. METHODS In this randomized four-visit bilateral crossover study, 24 licensed regular drivers and established wearers of soft contact lenses were enrolled. Subjects wore in random order each of three study lens types: the investigational photochromic soft contact lens (test), a nonphotochromic soft contact lens (control 1), and plano photochromic spectacle lenses (control 2). Driver performance was assessed on a closed-circuit driving track under challenging controlled conditions. The primary endpoint was overall driving performance score calculated as a composite Z score of six objective metrics. RESULTS All 24 subjects (mean age, 29.8 years) completed the study. For nighttime driving, the adjusted mean differences in Z score (95% confidence interval) between test and control 1 and between test and control 2 were 0.069 (−0.045 to +0.183) and 0.117 (0.003 to 0.231), respectively. For daytime driving, mean differences were 0.101 (−0.013 to +0.216) between test and control 1 and 0.044 (−0.070 to +0.158) between test and control 2. Results demonstrated noninferiority of the test lens relative to controls for nighttime and daytime driving performance using a noninferiority margin of −0.25 Z score. Noninferiority was also demonstrated on all logMAR and contrast threshold testing. No adverse events were reported during the study. CONCLUSIONS Study results revealed no evidence of concerns with either driving performance or vision while wearing photochromic contact lenses.

SIGNIFICANCE Photochromic soft contact lenses contain light-sensitive additives that allow them to darken when exposed to ultraviolet or violet light. One question, however, is whether the lenses influence vision indoors (minimally activated). In this study, we found that the minimally activated lenses improved many aspects of visual function under bright light. PURPOSE Photochromic contact lenses were designed to darken when exposed to outdoor sunlight. The filtering that results improves visual function under bright light conditions. Not all bright light exposures occur outdoors. In this study, we tested whether a photochromic contact lens improved visual function under conditions where the lens was minimally activated (i.e., no more than it normally would be in an indoor environment). METHODS A subject-masked contralateral design was used comparing a photochromic contact lens randomized to one eye against a nonphotochromic contact in the other eye of the same subject. Sixty subjects (mean = 34.90 ± 11.24 years) were tested. The primary endpoints consisted of four visual function outcomes: photostress recovery, glare disability, glare discomfort, and chromatic contrast. Photostress recovery was quantified by measuring the time needed to recover visual acquisition of a grating target after 5 seconds of an intense xenon white flash exposure; glare disability was evaluated as the energy in a surrounding xenon white annulus necessary to veil a central grating target; and glare discomfort was assessed using bioimaging of the squint response. Chromatic contrast was measured as thresholds for a green-yellow (580 nm) grating target superposed on a blue (460 nm) background. RESULTS The minimally activated photochromic contact demonstrated improved visual performance compared with the nonphotochromic control across all visual functions tested ( P < .01). CONCLUSIONS Even under conditions of exiguous activation (e.g., as would be expected indoors or while driving at night), a photochromic contact will improve many of the more deleterious aspects of bright light.