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Tetsuya Kawakita, Etsuko Takamura, Jun Shimazaki, Junko Ogawa, Miki Uchino, Kazumi Fukagawa, Kenichi Yoshino, Mari Tanaka, Machiko Shimmura-Tomita, Kazuo Tsubota; Prospective, Randomized, Multicenter, Double-Blind Placebo-Controlled Study of the Safety and Efficacy of 1% D-3-Hydroxybutyrate eye drop for the Treatment of Dry Eye. Invest. Ophthalmol. Vis. Sci. 2013;54(15):941. doi: https://doi.org/.
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To D-3- hydroxybutyrate( BHB) is the most abundantly produced physiological ketone, is a fatty acid-derived substrate that plays key role in mammalian energy metabolism. BHB has been demonstrated to be effective in neurological disorders such as Alzheimer’s, Parkinson’s, and Huntington’s disease in animal models and humans We showed that topically applied BHB ameliorates corneal epithelial erosion and superficial punctate keratopathy, a hallmark of corneal surface symptoms of dry eye, in a rat dry eye model (IOVS 2003, 2005). The purpose of this study is to investigate the safety and efficacy of 1% BHB eye drop in the treatment of dry eye patient.
Prospective, randomized, multicenter, double-blind placebo-controlled study were performed. A total of 65 dry eye patients were randomly assigned to placebo (n=33) and 1% BHB eye drop (n=32) and patients were received 6 times a day for 4 weeks. Corneal fluoresecin staining, cornea and conjuctival rose bengal staining, tear film BUT, Schirmer test and subjective symptoms were evaluated.
In the corneal rose bengal score, statistically significant improvement was observed between the placebo and 1% BHB drop at 2 and 4 week (P < 0.05). In the corneal fluorescein staining score, significant improvement was observed between placebo and 1% BHB eye drop at 2 week in the patient with Schirmer ≤ 5 mm (n=38, P < 0.05). Trend toward a significant improvement between placebo group and 1% BHB eye drop at week 4 in the patient with Schirmer ≤ 5 mm with apparent foreign sensation (n=23, P < 0.1). There was no significant difference in tear film status and subjective symptoms between placebo and 1% BHB eye drop. All of adverse effects were mild ocular symptoms and spontaneously recovered in both group.
These results indicate that 1% BHB is safe and effectiveness in the treatment of ocular surface disorder in tear-deficient dry eye patient.
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