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Clinical Usefulness of Diquafosol for Real-World Dry Eye Patients: A Prospective, Open-Label, Non-Interventional, Observational Study

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Abstract

Introduction

This study was designed to evaluate the efficacy and safety of 3% diquafosol ophthalmic solution in dry eye patients in clinical practice.

Methods

Subjects were dry eye patients who had never used diquafosol, and observation was conducted prospectively over 2 months. The corneal and conjunctival fluorescein staining score, tear film break-up time, 12 dry eye-related subjective symptoms, patient-reported outcomes, and adverse events were investigated.

Results

Data were collected from 465 medical institutions for 3,196 patients. Diquafosol led to significant improvement in all subjective symptoms and objective findings (P < 0.001, paired t test). Diquafosol was effective regardless of the degree of severity according to the corneal and conjunctival fluorescein staining score or therapeutic pattern. Overall, 76.0% patients responded that their condition had improved. Adverse reactions were observed in 6.3% of patients. The major adverse reactions were eye discharge, eye irritation, and eye pain.

Conclusion

Diquafosol was effective for various dry eye patients in clinical practice, and no significant safety-related problems occurred.

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Acknowledgments

Sponsorship and article processing charges for this study were funded by Santen Pharmaceutical Co., Ltd. Osaka, Japan. All named authors meet the ICMJE criteria for authorship for this manuscript, take responsibility for the integrity of the work as a whole, and have given final approval to the version to be published. All authors had full access to all of the data in this study and Takeshi Nishijima takes complete responsibility for the integrity of the data and accuracy of the data analysis.

Conflict of interest

Masahiko Yamaguchi has received honoraria for medical advice on this study and honoraria for writing and reviewing this manuscript from Santen. Takeshi Nishijima is an employee of Santen. Jun Shimazaki has received honoraria for medical advice on this study from Santen, and consulting fees from Otsuka and honoraria for lectures from Abbot, Alcon, Novartis, Otsuka, and Santen. Etsuko Takamura has received honoraria for medical advice on this study from Santen, and consulting fees from Alcon, Astellas, GlaxoSmithKline, Kissei, Kyowa Hakko Kirin, Maruho, MSD, Nippon Boehringer Ingelheim, Novartis, Otsuka, Pfizer, Senju, and Wakamoto. Norihiko Yokoi has received honoraria for medical advice on this study from Santen, and consulting fees from Kissei and Rohto. Hitoshi Watanabe has received honoraria for medical advice on this study from Santen. Yuichi Ohashi has received honoraria for medical advice on this study from Santen, and consulting fees from HOYA, Johnson and Johnson, Otsuka, Santen, and Senju.

Compliance with ethics guidelines

This study was conducted on the basis of a request from a regulatory agency in Japan. It was a multi-institutional, prospective, non-interventional, observational study that conformed to the Good Post-Marketing Study Practice (Ministry of Health, Labor and Welfare ordinance 171, December 20, 2004). The study protocol was reviewed and approved in advance by the Pharmaceuticals and Medical Devices Agency, Japan. For this reason, no ethical review by the individual facilities participating in the study was conducted. Because informed consent was not required for post-marketing observational studies that were requested by the regulatory agency in Japan, the present study did not solicit informed consent from the patients.

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Authors and Affiliations

  1. Ehime University School of Medicine, Ehime, Japan

    Masahiko Yamaguchi & Yuichi Ohashi

  2. Santen Pharmaceutical Co., Ltd, Osaka, Japan

    Takeshi Nishijima

  3. Tokyo Dental College Ichikawa General Hospital, Chiba, Japan

    Jun Shimazaki

  4. Tokyo Women’s Medical University, School of Medicine, Tokyo, Japan

    Etsuko Takamura

  5. Kyoto Prefectural University of Medicine, Kyoto, Japan

    Norihiko Yokoi

  6. Kansai Rosai Hospital, Hyogo, Japan

    Hitoshi Watanabe

Authors
  1. Masahiko Yamaguchi
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  2. Takeshi Nishijima
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  3. Jun Shimazaki
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  4. Etsuko Takamura
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  5. Norihiko Yokoi
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  6. Hitoshi Watanabe
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  7. Yuichi Ohashi
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Corresponding author

Correspondence to Takeshi Nishijima.

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Yamaguchi, M., Nishijima, T., Shimazaki, J. et al. Clinical Usefulness of Diquafosol for Real-World Dry Eye Patients: A Prospective, Open-Label, Non-Interventional, Observational Study. Adv Ther 31, 1169–1181 (2014). https://doi.org/10.1007/s12325-014-0162-4

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  • DOI: https://doi.org/10.1007/s12325-014-0162-4

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