Comparison of Clinical Performance and Fit Success of Lehfilcon A and Lotrafilcon B Daily Wear Monthly Replacement Silicone Hydrogel Multifocal Contact Lenses in Patients with Presbyopia

Purpose: To compare and evaluate the clinical performance and fit success of lehfilcon A and lotrafilcon B multifocal soft contact lenses (MfSCLs). Patients and Methods: This was a prospective, randomized, double-masked, crossover, dispensing clinical study. Eligible wearers were fitted and wore study MfSCLs bilaterally (≥8 hours/day, ≥5 days/week) over 30 days. Endpoints: binocular visual acuity (VA) at distance (4 m), intermediate (80 cm), and near (40 cm) at day 30; fit rate success; eye care professional (ECP) rating, study dispensed lens power at visit 1; lens fit, and surface characteristics at dispense and day 30; safety assessments. Results: Overall, 101 subjects were enrolled. At day 30, lehfilcon A MfSCLs were noninferior to lotrafilcon B MfSCLs for distance, intermediate, and near VA (non-inferiority margin: 0.05; 95% UCL of LSM difference 0.00, 0.02, 0.04; mean VA, lehfilcon A: -0.10 ± 0.08, -0.10 ± 0.08, and 0.01 ± 0.12; lotrafilcon B: -0.09 ± 0.07, -0.11 ± 0.08, and -0.02 ± 0.11). At visit 1, ≥99.5% of both MfSCLs achieved successful fit with 1-2 lenses/eye. Mean ECP ratings for ease of fit: lehfilcon A 9.8 ± 0.6; lotrafilcon B: 9.7 ± 0.6. About 96.0% of subjects had same sphere (D) power and 100.0% had same ADD power in both eyes for both lenses. All MfSCLs had optimal/acceptable fit. Majority of MfSCLs (>96%) had grade 0/1 front surface wettability and front/back surface deposits. No serious AEs were reported, and all biomicroscopy findings were graded 2 (mild) or lower. Conclusion: Lehfilcon A multifocal contact lenses combine excellent visual performance, high fit success, and a stable, comfortable wearing experience over 30 days of daily wear. With their water-gradient surface, favorable safety profile, and ease of fit, they represent a reliable and beneficial option for clinicians to consider when selecting multifocal lenses for presbyopic patients.