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The Effect of Diquafosol Ophthalmic Solution on Clinical Parameters and Visual Function in Soft Contact Lens-Related Dry Eye

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Abstract

Introduction

This study evaluated the efficacy and safety of diquafosol ophthalmic solution (DQS) in soft contact lens (SCL)-related dry eye using artificial tear as a control.

Methods

This study enrolled 26 patients with SCL-related dry eye. DQS and artificial tears (AT) were instilled into the right and left eyes, respectively, with their SCLs on. Dry eye examinations (including tear film breakup time, tear volume, and staining score) were performed and visual function (including contrast sensitivity) was also evaluated before (at baseline) and after treatment (at 4- and 8-week examinations). Subjective symptoms were assessed separately in each eye using a questionnaire on dry eye in contact lens wearers. The results were compared before and after treatment, and between the right eyes treated with DQS (the DQS eye) and the left eyes treated with AT (the AT eye) using the mixed effect model.

Results

Corneal and conjunctival staining scores at 8-week examination were significantly lower than those at baseline in the DQS eye (p = 0.03; p < 0.001, respectively), but no significant changes were observed in the AT eye. Most subjective symptoms improved significantly in both the DQS and AT eyes. However, major subjective symptoms (dryness and blurry vision) improved significantly only in the DQS eye at 8-week examination. Contrast sensitivity at 8-week examination in the DQS eye improved significantly at 12 cycles/degree compared to baseline (p = 0.001) and was significantly better than that in the AT eye (p = 0.03). There were no adverse events related to DQS or AT.

Conclusions

DQS was effective and safe for SCL-related dry eye. DQS also improved contrast sensitivity.

Trial Registration

University Hospital Medical Information Network Clinical Trials Registry (UMIN-CTR), Identification No. UMIN000024064.

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Acknowledgements

We wish to express our gratitude to the physicians and staff at the medical institutes that participated in the study.

Funding

Sponsorship and article processing charges, including the journal’s Rapid Service Fees, for this study were funded by Santen Pharmaceutical Co., Ltd., Osaka, Japan.

Medical Writing and Editorial Assistance

We would like to thank Editage (http://www.editage.com) for English language editing. The source of funding for the assistance provided by Editage was funded by Santen Pharmaceutical Co., Ltd., Osaka, Japan.

Authorship

All named authors meet the International Committee of Medical Journal Editors (ICMJE) criteria for authorship for this article, take responsibility for the integrity of the work as a whole, and have given their approval for this version to be published.

Authorship Contributions

Conceptualization: Tomohiro Ogami, Hiroki Asano, Takahiro Hiraoka, and Yoshiaki Yamada. Methodology: Tomohiro Ogami, Hiroki Asano, Takahiro Hiraoka, and Yoshiaki Yamada. Investigation: Tomohiro Ogami and Hiroki Asano. Data curation: Tomohiro Ogami and Hiroki Asano. Data analysis: Tomohiro Ogami, Hiroki Asano, Takahiro Hiraoka, and Yoshiaki Yamada. Writing–original draft preparation: Yoshiaki Yamada. Writing–review and editing: Tomohiro Ogami, Hiroki Asano, Takahiro Hiraoka, and Tetsuro Oshika. Supervision: Takahiro Hiraoka and Tetsuro Oshika. All authors read and approved the final manuscript.

Disclosures

Tomohiro Ogami has received research funding from Santen Pharmaceutical Co., Ltd. and has received lecture fees from Santen Pharmaceutical Co., Ltd. Current affiliation is Miyakubo Eye Clinic, Gunma, Japan. Hiroki Asano has received research funding from Santen Pharmaceutical Co., Ltd. and has received lecture fees from Santen Pharmaceutical Co., Ltd. Current affiliation is Tsuchiura Kyodo General Hospital, Ibaraki, Japan. Takahiro Hiraoka has received lecture fees from Santen Pharmaceutical Co., Ltd. Yoshiaki Yamada is an employee of Santen Pharmaceutical Co., Ltd. Tetsuro Oshika has received research funding from Santen Pharmaceutical Co., Ltd. and has received lecture fees from Santen Pharmaceutical Co., Ltd. The authors have no other conflicts of interest to declare.

Compliance with Ethics Guidelines

All participants were provided with a full explanation about the study and they provided written informed consent. This study followed the tenets of the Declaration of Helsinki, and was approved by the institutional review board and the ethics committee at each study site (namely the Ibaraki Seinan Medical Center Hospital ethics committee and Namegata District Medical Center ethics committee, reference number; 16-2).

Data Availability

The datasets generated during and/or analyzed during the current study are available from the corresponding author on reasonable request.

Author information

Author notes

  1. Tomohiro Ogami and Hiroki Asano contributed equally to this article as co-first authors.

Authors and Affiliations

  1. Ibaraki Seinan Medical Center Hospital, Ibaraki, Japan

    Tomohiro Ogami

  2. Tsuchiura Kyodo General Hospital Namegata District Medical Center, Ibaraki, Japan

    Hiroki Asano

  3. Department of Ophthalmology, Faculty of Medicine, University of Tsukuba, 1-1-1 Tennoudai, Tsukuba, Ibaraki, 305-8575, Japan

    Takahiro Hiraoka & Tetsuro Oshika

  4. Japan Medical Affairs, Development Management Department, Japan Business, Santen Pharmaceutical Co., Ltd., Osaka, Japan

    Yoshiaki Yamada

Authors
  1. Tomohiro Ogami
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Corresponding author

Correspondence to Takahiro Hiraoka.

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Ogami, T., Asano, H., Hiraoka, T. et al. The Effect of Diquafosol Ophthalmic Solution on Clinical Parameters and Visual Function in Soft Contact Lens-Related Dry Eye. Adv Ther 38, 5534–5547 (2021). https://doi.org/10.1007/s12325-021-01910-8

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  • DOI: https://doi.org/10.1007/s12325-021-01910-8

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