Clinical Performance of a Novel Daily Disposable Soft Contact Lens

Abstract

Background and Objective: Verofilcon A (PRECISION1®; Alcon) silicone hydrogel daily disposable contact lenses were designed to address clinical issues associated with new wearer discontinuation, including vision quality, sustained comfort, and ease of handling. The present study assessed the objective and subjective performance of verofilcon A contact lenses in subjects needing optical correction for refractive ametropia. Material and Methods: Subjects aged 18 years and older with non-diseased eyes, a history of successful soft contact lens wear for distance correction in both eyes during the previous 3 months, and a best spectacle-corrected visual acuity of 20/25 or better with a manifest cylinder of ≤ 0.75 diopters in each eye were recruited. The primary endpoint was distance visual acuity. Secondary endpoints included subjective ratings of overall vision, comfort, and handling, and safety endpoints included adverse events and biomicroscopy/slit lamp examination findings. Results: This study recruited 70 subjects (140 eyes), aged 20–48 years, who were predominantly white (93%), non-Hispanic/Latino (94%), and female (73%); one subject discontinued due to a change in residence. Of the 140 eyes, 132 (94.3%) had 20/20 or better vision with their habitual contact lenses. Similarly, of the 138 eyes that completed the study, 136 (98.6%) had 20/20 or better vision at dispensation of verofilcon A lenses and 132 (95.7%) had 20/20 or better vision at 3 months. Mean ± SD subjective ratings of overall vision, overall comfort, and overall handling, each on a 10-point scale, were 9.4 ± 0.8, 9.4 ± 0.8, and 9.2 ± 1.3, respectively, at lens dispensing, and 9.4 ± 0.9, 9.5 ± 0.8, and 9.2 ± 1.0, respectively, at 3 months. Mean ± SD daily wear times at 1 week and 3 months were 14.71 ± 1.85 and 15.05 ± 1.27 hours, respectively, with 68.1% at 1 week and 73.9% at 3 months wearing verofilcon A lenses for 14–18 hours per day. None of the subjects experienced a serious adverse event or discontinued lens wear, with biomicroscopy/slit lamp examination showing no evidence of corneal edema or chemosis. Conclusion: Subjects wearing verofilcon A lenses had visual acuity similar to that when wearing their habitual lens. Verofilcon A lenses were highly rated for vision quality, comfort, and handling. Verofilcon A lenses may be an option for subjects with refractive ametropia who desire lenses that can be worn for >14 hours per day and are easy to handle.