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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 +1 678 415 5272, Email holly.lorentz@alcon.comPurpose: 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 |
