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A Clinic-based Survey of Clinical Characteristics and Practice Pattern of Dry Eye in Japan

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Abstract

Introduction

The aim of this study was to investigate the clinical characteristics and practice pattern of patients with dry eye disease (DED) in eye clinics across Japan.

Methods

A multi-center, cross-sectional study was conducted among patients with DED who visited eye clinics in Japan. Subjective symptoms, patient’s background, ocular surface features, and tear function were evaluated. Main outcome measures were tear break-up time (TBUT), Schirmer I value, kerato-conjunctival staining score, and dry eye symptom questionnaire score.

Results

Initially, 463 subjects were enrolled, and 449 cases (63 male and 386 female; mean age, 62.6 ± 15.7 years) were included in the final analysis. Overall, 94.9% of patients had a shortened TBUT (≤5 s), and 54.6% had an aqueous tear deficiency (Schirmer I value ≤5 mm). The most prevalent subtype of dry eye was aqueous-deficient dry eye, which was present in 35.0% of all patients, followed by short-BUT-type dry eye, which was seen in 26.7%.

Conclusion

The two most common DED subtypes were aqueous-deficient and short-BUT-type dry eye. Shortened TBUT is the most common feature of dry eye, regardless of subtype. The current treatment choice mainly consisted of hyaluronic acid, two novel mucin secretagogues, diquafosol and rebamipide, and steroidal eye drops.

Trial Registration: University Hospital Medical Information Network: UMIN (registries no. UMIN 000015890).

Funding: Japan Dry Eye Society, Tokyo, Japan, and Santen Pharmaceutical Co., Ltd., Osaka, Japan.

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Acknowledgements

This study and publication charges were funded by the Japan Dry Eye Society, Tokyo, Japan, and Santen Pharmaceutical Co., Ltd., Osaka, Japan.

The present study was conducted by the joint study organization of the Dry Eye Society and Santen Pharmaceutical Co., Ltd. Both organizations contributed to the creation of documents including the study protocol, management of study progress, and provided information and support to the study sites, evaluation of the data analysis, disclosure of the outcome of the study, and entry/update of the present study in the public registration system.

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

The DECS-J Study Group: The following individuals participated in the study. Central Unit: Motoko Kawashima, Masakazu Yamada, Kazuhisa Suwaki, Chika Shigeyasu, Yoshimune Hiratsuka, Norihiko Yokoi, Kazuo Tsubota. Study group investigators and clinical sites: Yoshitsugu Tagawa (Kitaichijo Tagawa Eye Clinic, Sapporo, Hokkaido, Japan), Seika Den (Akasaka Tokyu Shimazaki Eye Clinic, Tokyo, Japan), Miki Iwasaki (Ryogoku Eye Clinic, Tokyo, Japan), Hiroshi Saito (Saito Eye Clinic, Saitama, Japan), Reiko Ishida (Ishida Clinic, Shizuoka, Japan), Aoi Komuro (Shijo-karasuma Komuro Eye Clinic, Kyoto, Japan), Naoki Iwasaki (Iwasaki Eye Clinic, Osaka, Japan), Harue Matsumoto (Matsumoto Eye Clinic, Tokushima, Japan), Tomoko Goto (Hanamizuki Eye Clinic, Ehime, Japan), Atsuko Kiyosawa (Kiyosawa Eye Clinic, Fukuoka, Japan).

Disclosures

Kazuhisa Suwaki: employee of Santen Pharmaceutical Co., Ltd.

Masakazu Yamada: consultant for Otsuka Pharmaceutical Co. Ltd, and Johnson & Johnson Vision Care Co.

Norihiko Yokoi: consultant for Kissei Co., Ltd., and Rohto Co., Ltd.

Kazuo Tsubota: consultant, speaker’s bureau member and grant recipient of Santen Pharmaceutical Co., Ltd.; speaker’s bureau member and grant recipient of Otsuka Pharmaceutical Co., Ltd.

Motoko Kawashima, Chika Shigeyasu, Yoshimune Hiratsuka, and Miki Uchino have nothing to disclose.

Compliance with Ethics Guidelines

This study protocol was approved by the Institutional Review Board of Clinical Study of Ryogoku Eye Clinic Tokyo, Japan. This study was conducted in accordance with the guidelines of the World Medical Association Declaration of Helsinki and Ethical Guidelines for Medical and Health Research involving Human Subjects in Japan. The subjects received a full explanation of the procedures and provided their written informed consent for participation prior to inclusion in the study. The study was registered in the public registration system [University Hospital Medical Information Network: UMIN (Registries No. UMIN 000015890)].

Data Availability

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

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Correspondence to Motoko Kawashima.

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Kawashima, M., Yamada, M., Suwaki, K. et al. A Clinic-based Survey of Clinical Characteristics and Practice Pattern of Dry Eye in Japan. Adv Ther 34, 732–743 (2017). https://doi.org/10.1007/s12325-017-0487-x

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