Evaluation of Tear Film Break-Up Time after First-Time Wearing of Verofilcon A Silicone Hydrogel, 1-day Disposable Contact Lenses: FTVeA study

Naoko Misu,Tatsuya Mimura,Hidetaka Noma,Makoto Kawashima,Yoshinobu Mizuno, Masao Yoshizumi, Koichiro Shinbo, Yoshio Inoue

Research Square (Research Square)(2023)

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摘要
Abstract Purpose The dryness and discomfort associated with soft contact lenses (SCLs) prevent their continued use. Recently, verofilcon A, a new daily disposable silicone hydrogel material SCL, was introduced, which has a high-water content (surface water content of 80% or more) that overcomes the low water content drawback of silicone hydrogels. Furthermore, the surface treatment with SMARTSURFACE® Technology is expected to improve water-wettability during SCL wear. In this study, we evaluated the non-invasive tear break-up time (NIBUT) and comfort level in individuals wearing verofilcon A SCL for the first time. Methods We enrolled 42 first-time SCL wearers, comprising 84 eyes. NIBUT was measured using the DR-1α® dry eye observation device, at the state of the naked eye before SCL wear (baseline), and at 1 and 4 weeks after the first SCL wear. Additionally, we conducted a questionnaire survey during the fourth week to assess the comfort level (0–10) of SCL wear. Results The NIBUT values were significantly higher at 1 week (10.8 ± 2.2 s, p < 0.01) and 4 weeks (11.4 ± 2.2 s, p < 0.01) after the first SCL wear than those at baseline (5.9 ± 2.0 s). Comfort level in SCL use was significantly higher at 1 week (9.0 ± 1.1, p < 0.01) and 4 weeks (8.7 ± 1.2, p < 0.01) than that at baseline (7.8 ± 1.8), and this level was higher regardless of the baseline NIBUT value. Conclusion Prolonged BUT and increased comfort levels were observed in individuals wearing verofilcon A SCLs. Improvement in tear fluid retention was found to alleviate dry eye and discomfort, suggesting that verofilcon A may be a beneficial introductory lens for the first-time SCl wearers. Trial registration number and date: UMIN registration numbers: UMIN000041107 (July/15/2020) and UMIN000042265 (October/28/2020)
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