1-Week Dispensing Evaluation of Kalifilcon A Toric Contact Lenses Compared to Ultra for Astigmatism

Overview

This single-site, randomized, double-masked (participant and investigator), 2-way crossover, repeated-measures dispensing study evaluated the visual performance of kalifilcon A daily disposable toric (LD213001) contact lenses compared with commercially available Ultra for Astigmatism (samfilcon A) contact lenses in experienced soft contact lens wearers requiring astigmatic correction. Each participant wore both lens types as daily disposable lenses for approximately one week each, in a randomized order.

Experienced toric soft contact lens wearers were enrolled and attended a Screening/Baseline visit (informed consent, eligibility, sphero-cylindrical baseline refraction). Participants were fit and dispensed either Test (kalifilcon A LD213001) or Comparator (Ultra for Astigmatism, samfilcon A) lenses in both eyes per a randomization schedule and wore them for \~1 week (7 ±3 days), ≥8 hours/day. Measurements (high-contrast logMAR visual acuity, visual quality, comfort, lens fit, and ocular health) were taken at the dispensing (insertion) visit and the 1-week follow-up visit. Participants then crossed over to the other lens type for a second \~1-week period. Continuous data were summarized with descriptive statistics; paired t-tests were used for parametric measures (p\<0.05 significant). Non-inferiority margin for mean binocular logMAR VA was 0.06.

Conditions

Interventions

Eligibility

Locations (1)

Outcomes