Performance of a Silicone Hydrogel Daily Disposable Contact Lens among Wearers with Lens-related Dryness

Abstract

Background: Addressing contact lens dryness continues to be a development goal of contact lens (CL) manufacturers. Objective: The objective of this study is to evaluate the clinical performance of kalifilcon A, a daily disposable silicone hydrogel (SiHy) CL, in subjects that experience dryness with their habitual planned-replacement SiHy CLs relative to a non-dry subgroup. Methods: A cohort of adapted planned-replacement SiHy CL wearers wore kalifilcon A lenses for at least 8 hours daily over two weeks. After one week of lens wear, subjects completed a survey regarding their lens wearing experience with respect to comfort and vision. Subsequently, subjects visited the clinics for the 2-week visit, during which the investigators completed a slit lamp exam and questionnaire regarding lens performance. Results: The evaluation included 180 subjects experiencing CL dryness with their habitual SiHy lenses and 213 subjects that did not. Both subgroups largely agreed with all comfort and vision attribute statements, and the dryness subgroup expressed higher levels of agreement with most comfort-related statements. Among habitual rewetting drop users, 73.9% in the dryness subgroup and 73.1% in the non-dry subgroup used drops less frequently while wearing kalifilcon A lenses. Investigators found no > Grade 2 slit-lamp findings, nor differences between subgroups. Neither subgroup showed a change in ratings between visits, except for a significantly higher proportion of improvers in the non-dry subgroup for upper lid tarsal conjunctival abnormalities. Conclusion: The kalifilcon A lens performed well among habitual planned-replacement SiHy CLs wearers. Its unique chemistry can provide a more satisfying wear experience for SiHy lens wearers experiencing CL dryness.

Comparative Analysis of the Osmoprotective Effects of Daily Disposable Contact Lens Packaging Solutions on Human Corneal Epithelial Cells

“…Components included in the kalifilcon A solution were selected based upon recommendations from the TFOS DEWS II report, 37 while maintaining ocular surface homeostasis in mind. 86 Surfactants promote tear film spreading 98 and stabilize protein structure. 99 Poloxamine 1107 is reported to be especially effective at suppressing aggregation of heat-denatured lysozyme.…”

“…While improving lens water retention during wear represents one approach, 84,85 infusion of beneficial ingredients into the lens is another. 86 All lenses evaluated in this study include humectant and/or surfactant wetting agents in the solution; the kalifilcon A lens additionally includes osmoprotectants also used in other ocular solutions, 36,37 as well as potassium electrolyte. 57 While physical and chemical characterization of CL packaging solutions is beyond the scope of this study, published literature demonstrates broad ranges in pH, osmolarity, and surface tension of commercial CL blister package solutions, as well as variation in contact angle between different lens/solution combinations, reflective of the surfactants in the solutions and the specific lenses.…”

“…While CLs packaged in solutions lacking osmoprotectants have acceptable performance in asymptomatic wearers and wearers experiencing only minor symptoms while wearing lenses, [92][93][94][95][96] a recent clinical study found that subjects who reported experiencing CL dryness symptoms with their habitual lenses noticed increased comfort while wearing the kalifilcon A lens. 86 In addition, a different study reported that CL wearers who used hypo-osmotic saline drops, which reduce tear osmolarity by dilution experienced improved end-of-day comfort and reduced dryness and burning. 97 We propose that while hyperosmotic stress leading to ocular inflammation in symptomatic patients results in discomfort, inclusion of osmoprotectants in CL packaging solutions can lead to decreased symptoms of discomfort.…”

In-vitro dehydration kinetics coefficient of Kalifilcon A and other contact lens materials

“…Notably, subjects engaged in physical activity provided more favorable ratings associated with vision and comfort. Similarly, a following study conducted clinical evaluations of Kalifilcon A CLs in subjects with and without dryness symptoms, providing further insights into their clinical performance 12 . Also in this case, both subgroups exhibited substantial concordance with all comfort and vision attribute statements.…”