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