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

Abstract

This study aimed to evaluate the non-invasive and subjective symptoms associated with Lehfilcon A water gradient silicone hydrogel contact lenses with bacterial and lipid resistance technology. A prospective, longitudinal, single-centre, self-controlled study was conducted among silicone hydrogel contact lens wearers. Non-invasive analysis of the pre-lens tear film was performed using the Integrated Clinical Platform (ICP) Ocular Surface Analyzer (OSA), and the meibomian glands were evaluated with the Cobra® HD infrared meibographer. After 30 days of contact lens wear, the subjects were re-evaluated to determine the changes in conjunctival redness, subjective dry eye disease, tear meniscus height, lipid pattern, and non-invasive break-up time. Results showed that the lipid layer thickness decreased significantly from 2.05 ± 1.53 to 0.92 ± 1.09 Guillon patterns, and the tear meniscus height decreased from 0.21 ± 0.04 to 0.14 ± 0.03. The mean pre-lens non-invasive break-up time (NIBUT) significantly increased from 15.19 ± 9.54 to 25.31 ± 15.81 s. The standard Patient Evaluation of Eye Disease (SPEED) score also decreased from 7.39 ± 4.39 to 5.53 ± 4.83. The results suggest that Lehfilcon A significantly reduced lipid and aqueous tear film volume but improved break-up time and subjective dry eye symptoms.

Characteristics of Pre-Lens Tear Film Behavior in Eyes Wearing Delefilcon A Silicone Hydrogel Water Gradient Contact Lenses

“…Moreover, and to our surprise, the NIBUT of the PLTF after 15 min of wearing delefilcon A is longer (i.e., clinically superior) than that of the PCTF prior to the lens being inserted. Similar findings of increased stability of the PLTF as compared to the PCTF over the "bare" corneal surface were recently reported for another SHWG, lehfilcon A [50]. It is unclear as to why delefilcon A showed such superiority, as it is thought that the wettability of the healthy corneal surface should be better than that of SCLs [12,13,22,23].…”

“…It should be noted that one limitation in this present study was the relatively small sample size of 30 individuals, as the enrollment of more volunteers was deemed unnecessary due to the preference of many CL wearers to stick to their usual CL of choice (i.e., they were reluctant to use other CL types). At the same time, n = 30 corresponds to the minimum number of volunteers reportedly considered sufficient for the application of the standard parametric and nonparametric statistical tests implemented in this type of study [29,33], and similar sample sizes were used in previous research on PLTF properties [48][49][50]. The good agreement of the main findings of the current study (i.e., superior PLTF dynamics and stability over the delefilcon A SHCL surface as compared to the SO-SCL and to PCTF after 30 min of SHWG-CL wear) agrees with the results reported in previous studies [42,[47][48][49][50] that used diverse sample sizes (n = 20 to 53 subjects) comprising individuals from various ethnicities and races (i.e., Asian, Latino, and Caucasian), thus supporting the general validity of the findings in this study.…”

Biomimetic-Engineered Silicone Hydrogel Contact Lens Materials

“…There are not many reports on the clinical evaluation of lehfilcon A lenses yet, but the results of evaluation of tear dynamics in patients with contact lens dry eye syndrome using lehfilcon A lenses have been investigated. − As a result, after 30 days of wearing, the tear lipid film thickness tended to decrease, and the blink interval tended to increase. These results demonstrate that wearing lehfilcon A lenses improves the stability of tear fluid and reduces the subjective symptoms of the dry eye.…”