A Randomized, Active-Controlled, Double-Masked, Crossover Study to Evaluate the Clinical Performance of Deseyne (Vifilcon C) Daily Disposable Soft Contact Lens for Presbyopia Extended Depth of Focus (EDOF)

The Deseyne daily disposable soft contact lens is intended for the correction of presbyopia and considered to be one of the growing class of extended depth of focus (EDOF) devices that uses a variety of strategies to provide useful intermediate and near vision. The lens is manufactured with vifilcon C material containing hyaluronic acid and tamarind seed polysaccharide, with a water content of 60% in a single diameter of 14.1 mm and base curve of 8.6 mm. The profile of the anterior surface is spherical across the 11-mm optic. Centrally, there is a 1.0 mm diameter zone that is optically inactive, contiguous with the optical zone. Light passes through the zone but is not intended to form a usable image. The central steep zone is at least 8.00 D steeper than the optical zone. The non-focusing central zone is intended to provide for an increased depth of focus, thus improving near and intermediate vision for the presbyopic patient. Deseyne (vifilcon C) daily disposable soft contact lenses are proposed to be indicated for the optical correction of refractive ametropia (myopia and hyperopia) in non-diseased eyes with up to 1.00 D of astigmatism that does not interfere with visual acuity (VA). A multicenter, randomized, active-controlled, double-masked, crossover study design will be used to compare the clinical performance of the Deseyne (vifilcon C) soft contact lens for Presbyopia EDOF (test) to the 1-Day Acuvue Moist (etafilcon A) soft contact lens for Single Vision (control). This is a 1-day crossover study (conducted over 2 visits) and will consist of approximately 75 subjects (75 study eyes \[all study eyes will be right eyes\]) randomly assigned in-office to wear the test or the control lens first. A 30-minute washout period will be scheduled between the crossover. Subjects must be otherwise healthy, with spectacle refraction between -6.00D and +4.00 D and astigmatism ≤1.00 D that does not interfere with VA.