Randomized Crossover Trial Evaluating the Impact of Senofilcon A Photochromic Lens on Driving Performance

Abstract

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.

The Effect of a Photochromic Contact Lens on Visual Function Indoors: A Randomized, Controlled Trial

“…These results do suggest that a photochromic contact lens could improve visual quality even when worn in a motor vehicle or inside buildings. Buch et al 17 showed that, relative to a matched clear contact, the photochromic contact (the same control and test lens as used in this study) improved sign recognition at a distance by 19% during nighttime driving (i.e., conditions of minimal activation). The question of whether it is the actual change in filtering or some other quality of the lens is not clear.…”

BCLA CLEAR – Contact lens technologies of the future

“…The recent introduction of photochromic lenses from Johnson & Johnson Vision (Jacksonville, FL, USA) may fill the gap left by the discontinuation of the MaxSight lenses, but to date no data on their use in athletes has been published. However, their value in reducing light scatter and improvements in other vision aspects have been presented [471][472][473]. Given the interest within the sports arena to even marginally improve any aspect of performance that provides a benefit to athletes, further development of tinted lenses for sports remains an area worthy of pursuit.…”

Lens fitting and subjective acceptance of senofilcon A with photochromic additive on a neophyte population

“…These disruptive lighting conditions include direct and reflected light from the sun, vehicle headlamps, and streetlights [18]. Current evidence suggests that drivers can safely wear photochromic contact lenses while driving during the day and at night [4]. A randomized, bilateral crossover trial found that both vision and driving performance were comparable between photochromic contact lenses, clear contact lenses, and photochromic spectacles.…”

“…The U.S. Food and Drug Administration approved the Test lens in April 2018 [2], and studies have investigated aspects of its performance, including its effect on visual recovery, squint response, and driving [3,4]. Nonetheless, the literature is yet to report the subjective vision experience of patients fitted with this lens.…”