Abstract
Purpose :
To obtain on-eye clinical performance data and assess contact lens alignment and fit characteristics of a novel toric silicone hydrogel contact lens (verofilcon A) for astigmatism
Methods :
In this prospective, open-label, single-arm, bilateral, multicenter clinical study, eyes of healthy participants were fitted with verofilcon A contact lenses. The study evaluated lens alignment and fit characteristics. Lens alignment was determined in terms of the percentage of lenses with axis orientation within ±5°, ±10°, and ±20° from the intended 90° axis; and lens oscillation with blink on a 4-point scale (none, <3°, 3° to 5°, and >5°). The lens fit characteristics were recorded in terms of lens position and movement. Safety endpoints assessed include adverse events (AEs), device deficiencies, and biomicroscopy findings
Results :
A total of 39 subjects (78 eyes; mean (SD) age, 34.1 (10.8) years; female, 66.7%) were exposed to study lenses. The mean (SD) lens settling time was 40.1 (56.8) seconds. At 10 minutes, the proportions of lenses orienting within ±20°, ±10°, and ±5° from the intended axis were 100%, 98.7%, and 89.7%, respectively. The mean (SD) absolute axis orientation at 2 minutes was 2.7 (3.6) degrees. The majority of lenses (98.7%) had less than 5° of oscillation or no oscillation with blink. All lenses studied achieved optimal or acceptable fit (optimal, 88.5%; acceptably tight, 6.4%; and acceptably loose, 5.1%) and optimal or acceptable centration (optimal, 97.4%; and acceptable decentration, 2.6%). There were no AEs, device deficiencies, or clinically relevant changes to biomicroscopic findings
Conclusions :
The novel toric verofilcon A contact lens showed optimal alignment and fit without any safety concerns. Owing to the unique material features, advanced surface technology, optimal lens alignment, and fitting characteristics of this lens, it could offer astigmats a better contact lens wearing experience
This abstract was presented at the 2022 ARVO Annual Meeting, held in Denver, CO, May 1-4, 2022, and virtually.