Safety and Efficacy of a New Water Gradient Biomimetic Monthly Replacement Spherical Contact Lens Material (Lehfilcon A)

Abstract

Gina Wesley,1 Brad Giedd,2 Bradley Hines,3 Katherine Bickle,4 Christopher Pearson,5 Holly Lorentz6 1Complete Eye Care of Medina, Hamel, MN, USA; 2Kindred Optics at Maitland Vision, Maitland, FL, USA; 3Optometry Group, Memphis, TN, USA; 4ProCare Vision Center, Granville, OH, USA; 5OMEGA Vision Center PA, Longwood, FL, USA; 6Alcon Research, LLC, Johns Creek, GA, USACorrespondence: Holly Lorentz, Alcon Research, LLC, 11460 Johns Creek Pkwy, Johns Creek, GA, 30097, USA, Tel [phone], Email [email protected]: The objective of this study was to evaluate the safety and performance of the investigational lens, lehfilcon A, when worn in a daily wear modality and replaced monthly as compared to the commercially available comfilcon A contact lens.Methods: This was a multicenter, prospective, controlled, double-masked, randomized, parallel-group clinical study with bilateral lens wear for 3 months. In all, 115 subjects completed the study (77 with test lehfilcon A and 38 with control comfilcon A contact lenses). Distance visual acuity (VA) was assessed using Snellen VA. Lens performance was assessed by examining lens fit/movement, centration, front surface wettability and front/back surface deposits using slit-lamp biomicroscopy.Results: At the 3-month follow-up visit, all eyes had a distance VA of 20/20 or better. Further, lens fit/movement was assessed as optimal in 92.9% of the eyes with lehfilcon A and 89.2% with comfilcon A. There were no ratings of unacceptably tight or loose fits for either contact lens material. Lens centration was assessed as optimal in 98.7% of eyes with lehfilcon A and 94.6% with comfilcon A. For front and back surface deposits, both materials showed minimal lens surface deposits. Front surface wettability was assessed as grade 0 or 1 for most of the study lenses in both lens groups across all attended study visits. There were no ocular adverse events related to the study lenses.Conclusion: Overall, lehfilcon A showed excellent VA, optimal lens fitting characteristics, a clean surface, high wettability, and low risk for adverse events after 3 months of lens wear.Keywords: biomimetic, comfilcon A, lehfilcon A, visual acuity, water gradient, contact lens

Keywords

• biomimetic
• comfilcon a
• lehfilcon a
• visual acuity
• water gradient
• contact lens