Randomized, Multicenter, Double–Blind Study of the Safety and Efficacy of 1%D-3-Hydroxybutyrate eye drops for Dry Eye Disease

• Published in: Scientific reports Vol. 6; no. 1; p. 20855
• Main Authors: Kawakita, Tetsuya, Uchino, Miki, Fukagawa, Kazumi, Yoshino, Kenichi, Shimazaki, Seika, Toda, Ikuko, Tanaka, Mari, Arai, Hiroyuki, Sakatani, Keiko, Hata, Seiichiro, Okano, Takashi, Tsubota, Kazuo
• Format: Journal Article
• Language: English
• Published: London Nature Publishing Group UK 11.02.2016; Nature Publishing Group
• Subjects: 3-Hydroxybutyric Acid - therapeutic use; 692/699/3161/3162; 692/699/3161/3163; Adult; Aged; Animals; Conjunctiva - drug effects; Conjunctiva - physiopathology; Cornea; Cornea - drug effects; Cornea - physiopathology; Double-Blind Method; Double-blind studies; Dry Eye Syndromes - drug therapy; Dry Eye Syndromes - physiopathology; Eye; Eye care products; Eye diseases; Female; Fluorescein; Fluorescein - chemistry; Fluorescein - metabolism; Fluorescent Dyes - chemistry; Fluorescent Dyes - metabolism; Humanities and Social Sciences; Humans; Male; Middle Aged; multidisciplinary; Ophthalmic Solutions - therapeutic use; Patient Safety; Prospective Studies; Rats; Rose Bengal - chemistry; Rose Bengal - metabolism; Science; Staining and Labeling; Tears - drug effects; West Bengal India; India
• ISSN: 2045-2322; 2045-2322
• DOI: 10.1038/srep20855

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.