Änderung der objektiv gemessenen bulbären Rötung und der Symptome nach Umstellung auf Tageslinsenmaterial mit Wassergradient

Abstract

Purpose. The purpose of this pilot study is to identify if fine graduated differences in objective redness of the eye exist in a cohort of non-symptomatic contact lens wearers. The pri- mary objective is the evaluation of change in bulbar redness when a non-symptomatic, 2-4 week contact lens wearer, is refitted to a Delefilcon A lens material. Secondary objectives include the determination of limbal redness, corneal and bulbar staining, and wearing comfort. Material and Methods. 52 habitual, asymptomatic, full time soft contact lens wearers were enrolled in a multicenter study. At the baseline visit, bulbar and limbal redness were measured objectively using the Redness-Scan of the Keratograph 5M (K5M). Habitual lenses, lens care type, comfort ratings and staining data were captured at baseline visit. A wash out phase of 6 ± 1 days was conducted in which the subjects did not wear any lenses before Delefilcon A lenses were dispensed at visit 2 (V2) for a wearing period of 26 ± 5 days. A follow up visit was planned after 6 ± 1 days from V2 and a final visit after additional 20 ± 4 days. During visits 2, 3 and 4, the same objective measurements were carried out and corresponding subjective data was captured. ANOVA, t-test for paired sam- ples, homogeneity test and Wilcoxon signed rank test were used for the statistical analyses. Results. A total number of 49 complete data sets were suc- cessfully evaluated. Objectively measured bulbar redness decreased by 0.121 (p = 0.003) from the baseline compared to the final visit. In the same period, limbal redness reduced by 0.151 (p = 0.000). In addition, an increase from 36 at baseline to 47 at V4 grade 0 ratings regarding corneal staining, and from 32 to 39 regarding bulbar staining was found, respec- tively. The averaged comfort rating with habitual lenses was 79.7 ± 16.6 compared to the final visit 89.0 ± 10.8. Conclusion. In the context of classic subjective grading hab- its which use fully grades in 1.0 steps, the objective Red- ness-Scan was able to detect finely graduated differences in the cohort of non-symptomatic wearers. The daily disposable test product delivers benefits to wearers in the form of re- duced bulbar and limbal redness, reduced corneal and bulbar staining, and statistically and clinically increased contact lens wearing comfort. Keywords contact lens, bulbar redness, wearing comfort