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

Tetsuya Kawakita, Miki Uchino, Kazumi Fukagawa, Kenichi Yoshino, Seika Shimazaki, Ikuko Toda, Mari Tanaka, Hiroyuki Arai, Keiko Sakatani, Seiichiro Hata, Takashi Okano, Kazuo Tsubota

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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.

Original languageEnglish
Article number20855
JournalScientific reports
Volume6
DOIs
Publication statusPublished - 2016 Feb 11

ASJC Scopus subject areas

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    Kawakita, T., Uchino, M., Fukagawa, K., Yoshino, K., Shimazaki, S., Toda, I., Tanaka, M., Arai, H., Sakatani, K., Hata, S., Okano, T., & Tsubota, K. (2016). Randomized, Multicenter, Double-Blind Study of the Safety and Efficacy of 1%D-3-Hydroxybutyrate eye drops for Dry Eye Disease. Scientific reports, 6, [20855]. https://doi.org/10.1038/srep20855