Abstract
Purpose :
To evaluate the clinical performance of commercially available, verofilcon A toric and stenfilcon A toric soft contact lenses (SCLs).
Methods :
A prospective, randomized, controlled, double-masked, bilateral, crossover, multicenter study was conducted in the US (NCT05483127). Habitual toric SCL wearers aged ≥18 years were randomized to wear verofilcon A toric or stenfilcon A toric SCLs bilaterally for 8-11 days, and crossed-over to the alternate toric SCLs. Primary endpoint was distance visual acuity (VA; logMAR) at week 1 (noninferiority margin: 0.05). Other endpoints evaluated at week 1: subjective ratings for “my lenses felt comfortable all day” at 16 hours (5-point scale: strongly agree to strongly disagree); lens movement (-2=unacceptably tight to +2=unacceptably loose); lens position (0=optimal centration to 2=unacceptable decentration); and front surface wettability (0=smooth uniform to 4=non-wettable); and front/back surface deposits (0=absent to 4=severe).
Results :
Overall, 152 subjects were randomized to the study toric SCLs (mean age: 34.4±9.0 years; female: 61.8%). Verofilcon A toric SCLs were noninferior to stenfilcon A toric SCLs for distance VA at week 1 (mean±SD logMAR: -0.11±0.07 vs -0.10±0.07; 95% UCL of LSM difference: -0.00). At 16 hours, more subjects using verofilcon A toric (53.7%) compared to stenfilcon A toric (43.6%) SCLs strongly agreed/agreed that the lenses felt comfortable all day (p=0.0165). Both toric SCLs had optimal/acceptable movement (in both primary and peripheral gazes) and optimal centration/acceptable decentration (verofilcon A toric: 100%; stenfilcon A toric: 100%). Most of the toric SCLs had grade 0 front surface wettability (verofilcon A: 86.4%; stenfilcon A: 85.4%) and surface deposits (verofilcon A: front 88.7%, back 95.4%; stenfilcon A: front 86.1%, back 94.0%) at week 1.
Conclusions :
Verofilcon A toric SCLs were noninferior to stenfilcon A toric SCLs for distance visual acuity at week 1. Verofilcon A toric SCLs had higher subjective ratings compared to stenfilcon A toric SCLs for comfort (at 16 hours). Both toric SCLs had optimal movement and centration, and clean wettable surface.
This abstract was presented at the 2024 ARVO Annual Meeting, held in Seattle, WA, May 5-9, 2024.