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Comparison of comfort and tear stability with two novel silicone-hydrogel daily disposable contact lenses

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Abstract

Background

The surface wettability of soft contact lenses (SCLs) affects the wearing comfort. Verofilcon A is a daily disposable silicone hydrogel contact lens with SMARTSURFACE® technology, ensuring high surface wettability.

Purpose

To evaluate tear stability on the surface of verofilcon A and narafilcon A SCLs and correlate these findings with clinical parameters and patients' discomfort.

Methods

Sixty-two SCL wearers (124 eyes) with SCL discomfort were randomly assigned to use narafilcon A (control SCL) and verofilcon A for 2 weeks each by crossover. The noninvasive tear break-up time (NIBUT) of the naked eye at baseline and pre-lens NIBUT (PL-NIBUT) of the SCL surface after 2 weeks of using each SCL were measured using the DR-1α® dry eye observation device. Corneal superficial punctate keratopathy (SPK) (0–3) and conjunctival hyperemia (0–3), and comfort level of SCL wear (1–10) were also evaluated.

Results

NIBUT and PL-NIBUT values were 4.6 ± 2.3 s for the naked eye, 6.6 ± 6.6 s for narafilcon A, and 11.3 ± 3.5 s for verofilcon A. verofilcon A had significantly higher PL-NIBUT than the naked eye and narafilcon A (p < 0.05). SPK (0.16 ± 0.48 vs. 0.00 ± 0.00, p < 0.01) and conjunctival hyperemia (1.15 ± 0.82 vs. 0.49 ± 0.50, p < 0.01) scores were lower when wearing verofilcon A than narafilcon A. The ocular comfort score of wearing SCLs was higher with verofilcon A than with narafilcon A (8.7 ± 1.8 vs. 9.8 ± 0.5, p < 0.01). The ocular comfort score for wearing verofilcon A was higher, regardless of the baseline NIBUT.

Conclusion

The results of this study showed a consistent surface-wetting advantage of verofilcon A in patients with ocular discomfort. verofilcon A was used comfortably in patients with low NIBUT scores at baseline. The findings suggest that verofilcon A is recommended for SCL wearers experiencing SCL-related dry eye symptoms and discomfort.

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Data availability statement

The data that support the findings of this study are available from the authors, but restrictions apply to the availability of these data, which were used under license from Teikyo University for the current study and are not publicly available. However, data are available from the authors upon reasonable request and with permission from the Teikyo University.

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Acknowledgements

We thank all the study investigators, staff, and patients who participated in this trial.

Funding

This work was supported in part by a Grant-in-Aid for Scientific Research from the Ministry of Education, Culture, Sports, Science, and Technology of Japan [Grant Number 20H04347] and an unrestricted investigator-initiated grant from Alcon Japan Ltd. (IIT#63215725) to Tatsuya Mimura, MD. The funders had no role in the study design, data collection and analysis, decision to publish, or preparation of the manuscript.

Author information

Authors and Affiliations

  1. Department of Ophthalmology, Teikyo University School of Medicine, 2-11-1 Kaga, Itabashi-ku, Tokyo, 173-8605, Japan

    Tatsuya Mimura

  2. Department of Ophthalmology, Hachioji Medical Center, Tokyo Medical University, Hachioji, Tokyo, Japan

    Hidetaka Noma

  3. Nerima Station West Eye Clinic, Nerima-Ku, Tokyo, Japan

    Masao Yamaguchi & Koichiro Shinbo

Authors
  1. Tatsuya Mimura
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  4. Koichiro Shinbo
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Contributions

All authors contributed to the conception and design of this study. Material preparation, data collection, and analyses were performed by HN, MY, TM. The first draft of the manuscript was written by TM, HN, and KS, and all authors commented on the previous versions of the manuscript. All the authors have read and approved the final version of the manuscript. All listed authors (Tatsuya Mimura, Hidetaka Noma, Masao Yamaguchi, Koichiro Shinbo) have approved the manuscript and agreed to its submission to the journal.

Corresponding author

Correspondence to Tatsuya Mimura.

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Conflict of interest

We certify that all our affiliations or financial involvement with any organization or financial conflicts with the subject matter discussed in the manuscript are completely disclosed in the acknowledgement section of the manuscript.

Ethics approval

This study was conducted in accordance with the ethical guidelines of the Declaration of Helsinki (World Medical Association 2013) and the Ethical Guidelines for Medical Health. The studies involving human participants were approved by the Teikyo University Ethical Review Committee (#20-166 and #SCR21-007). Several studies, including the current one, have been registered as clinical trials in the University Medical Information Network for Clinical Trials (UMIN-CTR) (UMIN registration numbers: UMIN000041107 and UMIN000042269) and the Japan Registry of Clinical Trials (jRCT) (jRCTs032210342).

Informed consent

Written informed consent was obtained from all participants after a complete explanation of the study content.

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Study setting: Nerima Station West Eye Clinic, Nerima-ku, Tokyo, Japan and Department of Ophthalmology, Teikyo University School of Medicine, Itabashi-ku, Tokyo, Japan.

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Mimura, T., Noma, H., Yamaguchi, M. et al. Comparison of comfort and tear stability with two novel silicone-hydrogel daily disposable contact lenses. Int Ophthalmol 44, 136 (2024). https://doi.org/10.1007/s10792-024-03075-z

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