Summary
PURPOSE: As patients age, they experience both the onset of presbyopia and a greater likelihood of symptoms of dry eyes. Here, the visual performance, comfort, and safety results are presented from a 3-week, prospective, open-label, multicenter study (NCT05660577) evaluating the kalifilcon A daily disposable multifocal contact lens (CL) in a subset of subjects with self-reported dry eyes at baseline.
METHODS: Habitual multifocal CL wearers ≥40 years of age with near-add requirements of +0.75 to +2.50 D were fitted with kalifilcon A multifocal CLs to be worn daily for 3 weeks, with scheduled in-office visits at 1 and 3 weeks. The pre-specified cohort with self-reported dry eyes per study baseline questionnaire was evaluated as a subgroup of interest (N=89 subjects/178 eyes). The primary outcome measure was the proportion of subjects agreeing that the CLs provide clear vision near, far, and in-between. Supportive endpoints included ratings of comfort, overall visual performance, (absence of) CL dryness, and overall impression (0–100 scale; 100=most favorable). Safety outcomes included adverse events (AEs).
RESULTS: In this cohort, 84.7% of those with an opinion agreed the CLs provide clear vision near, far, and in-between. For overall comfort, end-of-day comfort, overall visual performance, (absence of) CL dryness, and overall impression, subjects gave the study CL respective mean ratings of 91.9, 83.1, 85.0, 86.1, and 88.5 at the 1-Week visit and 93.4, 85.7, 87.0, 87.4, and 89.7 at the 3-Week visit; compared to their habitual (prior) CL ratings, mean study CL ratings at the 3-Week visit improved +16.6 in overall comfort, +26.0 in comfort at end of day, +12.8 in overall visual performance, +21.7 in (absence of) CL dryness, and +14.1 in overall impression. No serious AEs were reported.
CONCLUSIONS: Kalifilcon A daily disposable multifocal CLs were well-tolerated and demonstrated high visual performance and improved comfort in presbyopic individuals with self-reported dry eyes.