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

Abstract

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.

Evaluation of Celligent® Biomimetic Water Gradient Contact Lens Effects on Ocular Surface and Subjective Symptoms

“…Although elapsed SH-SCL use time is a determining factor in complication risks, some scientific trials confirmed increased bulbar redness after six hours of use [ 40 , 41 , 42 ]. In the current study, non-statistically significant changes in bulbar redness were observed after 30 days of use in 8 eyes and decreased in 16 eyes, and no changes were observed in 38 remaining eyes, which could be attributed to the last generation SH-SCL high oxygen permeability, as other researchers previously achieved [ 43 , 44 , 45 ].…”

Acanthamoeba spp. aggregate and encyst on contact lens material increasing resistance to disinfection

“…The properties of the aggregation-inducing contact lens materials that trigger this response are unknown and would require future investigation, but this response could potentially be due to diminished water content or surface topography of the contact lens materials. Acanthamoeba prefers to exist at the interfaces between soil and water, and surfaces indicating a strong water-aversion ( Liang et al, 2022 ; Wesley et al, 2022 ) may trigger the protective response.…”

Biomimetic-Engineered Silicone Hydrogel Contact Lens Materials

“…Therefore, the lehfilcon A lenses demonstrated excellent visual acuity, optimal lens fitting characteristics, clean surfaces, high wettability, and low risk of adverse events after 3 months of lens wear. A more detailed evaluation is expected in the future …”