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

Purpose: 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.