title: Randomized, Multicenter, Double-Blind Study of the Safety and Efficacy of 1%D-3-Hydroxybutyrate eye drops for Dry Eye Disease.
abstract: In a previous study, we demonstrated that topical D-beta-hydroxybutyrate ameliorates corneal epithelial erosion and superficial punctate keratopathy in a rat model of dry eye disease. In the current investigation, we performed a prospective, randomized, multicentre, double-blind, placebo-controlled study to assess the safety and efficacy of 1% D-3-hydroxybutyrate eye drops in patients with dry eye disease. A total of 65 patients were randomly assigned to either the placebo group or the 1% D-3-hydroxybutyrate group, and the treatments were administered 6 times a day for 4 weeks. We then evaluated corneal fluorescein staining, corneal and conjunctival rose Bengal staining, tear film break-up time (BUT), Schirmer score, and subjective symptoms. At both 2 and 4 weeks, the corneal rose Bengal score was significantly better in the 1% D-3-hydroxybutyrate group than in the placebo group. Among patients with an initial Schirmer score of ≤5 mm, the corneal fluorescein staining score was significantly better in the 1% D-3-hydroxybutyrate group than in the placebo group at two weeks. Mild ocular symptoms occurred in both groups, and these spontaneously resolved. The present study suggested that 1% D-3-hydroxybutyrate eye drops are safe and effective in treating ocular surface disorders in patients with tear-deficient dry eye disease.
authors: Department of Ophthalmology, Keio University School of Medicine, 35 Shinanomachi, Shinjuku, Tokyo Japan.
authors: Tetsuya
authors: T
authors: Kawakita
authors: Ryogoku Eye Clinic, 4-33-12, Ryogoku, Sumida, Tokyo Japan.
authors: Miki
authors: M
authors: Uchino
authors: Iidabashi Eye Clinic, 3-10-10, Iidabashi, Chiyoda, Tokyo Japan.
authors: Kazumi
authors: K
authors: Fukagawa
authors: Yoshino Eye Clinic, 1-20-10, Ueno, Taito, Tokyo Japan.
authors: Kenichi
authors: K
authors: Yoshino
authors: Shimazaki Eye Clinic, 2-4-13, Nagatacho, Chiyoda, Tokyo Japan.
authors: Seika
authors: S
authors: Shimazaki
authors: Minamiaoyama Eye Clinic, 3-3-11, Kitaaoyama, Minato, Tokyo Japan.
authors: Ikuko
authors: I
authors: Toda
authors: Yatsu Ekimae Azisai Eye Clinic, 4-6-19, Yatsu, Narashino, Chiba, Japan.
authors: Mari
authors: M
authors: Tanaka
authors: Minatomirai Eye Clinic, 4-7-1, Minatomirai, Nishi, Yokohama Kanagawa Japan.
authors: Hiroyuki
authors: H
authors: Arai
authors: Minatomirai Eye Clinic, 4-7-1, Minatomirai, Nishi, Yokohama Kanagawa Japan.
authors: Keiko
authors: K
authors: Sakatani
authors: Sky building Eye Clinic, 2-19-12, Takashima, Nishi, Yokohama, Kanagawa Japan.
authors: Seiichiro
authors: S
authors: Hata
authors: Smile Eye Clinic, 1-6-12, Aobadai, Aoba, Yokohama, Kanagawa Japan.
authors: Takashi
authors: T
authors: Okano
authors: Department of Ophthalmology, Keio University School of Medicine, 35 Shinanomachi, Shinjuku, Tokyo Japan.
authors: Kazuo
authors: K
authors: Tsubota
mesh_terms: D020155:3-Hydroxybutyric Acid / Q000627:therapeutic use*; D000328:Adult; D000368:Aged; D000818:Animals; D003228:Conjunctiva / Q000187:drug effects* / Q000503:physiopathology; D003315:Cornea / Q000187:drug effects* / Q000503:physiopathology; D004311:Double-Blind Method; D015352:Dry Eye Syndromes / Q000188:drug therapy* / Q000503:physiopathology; D005260:Female; D019793:Fluorescein / Q000737:chemistry / Q000378:metabolism; D005456:Fluorescent Dyes / Q000737:chemistry / Q000378:metabolism; D006801:Humans; D008297:Male; D008875:Middle Aged; D009883:Ophthalmic Solutions / Q000627:therapeutic use*; D061214:Patient Safety; D011446:Prospective Studies; D051381:Rats; D012395:Rose Bengal / Q000737:chemistry / Q000378:metabolism; D013194:Staining and Labeling; D013666:Tears / Q000187:drug effects*
chemical_list: D005456:Fluorescent Dyes; D009883:Ophthalmic Solutions; D012395:Rose Bengal; D019793:Fluorescein; D020155:3-Hydroxybutyric Acid