June 2013
Volume 54, Issue 15
Free
ARVO Annual Meeting Abstract  |   June 2013
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
Author Affiliations & Notes
  • Tetsuya Kawakita
    Ophthalmology, Keio Univ School of Medicine, Shinjuku-ku, Japan
  • Etsuko Takamura
    Tokyo Women's Medical University, Tokyo, Japan
  • Jun Shimazaki
    Tokyo Dental College,Ichikawa General Hospital, Chiba, Japan
  • Junko Ogawa
    Kitasato Institute Hospital, Tokyo, Japan
  • Miki Uchino
    Ryogoku Eye Clinic, Tokyo, Japan
  • Kazumi Fukagawa
    Iidabashi Eye Clinic, Tokyo, Japan
  • Kenichi Yoshino
    Yoshino Eye Clinic, Tokyo, Japan
  • Mari Tanaka
    Yatsuekimae azisai Eye Clinic, Tokyo, Japan
  • Machiko Shimmura-Tomita
    Ichikawa shapo Eye Clinic, Yatsuekimae azisai Eye Clinic, Chiba, Japan
  • Kazuo Tsubota
    Ophthalmology, Keio Univ School of Medicine, Shinjuku-ku, Japan
  • Footnotes
    Commercial Relationships Tetsuya Kawakita, None; Etsuko Takamura, None; Jun Shimazaki, Santen Pharmaceutical Co. (F), Otsuka Pharmaceutical Co. (F), Abott Medical Optics (F); Junko Ogawa, None; Miki Uchino, Santen Pharmaceutical Co (F); Kazumi Fukagawa, None; Kenichi Yoshino, None; Mari Tanaka, None; Machiko Shimmura-Tomita, None; Kazuo Tsubota, AcuFocus, Inc (C), Allergan (F), Bausch Lomb Surgical (C), Functional visual acuity meter (P), JiNS (P), Kissei (F), Kowa (F), Santen, Inc. (F), Otsuka (F), Pfizer (C), Thea (C), Echo Denki (P), Nidek (F), Ophtecs (F), Wakasa Seikatsu (F), CEPT Company (P)
  • Footnotes
    Support None
Investigative Ophthalmology & Visual Science June 2013, Vol.54, 941. doi:https://doi.org/
  • Views
  • Share
  • Tools
    • Alerts
      ×
      This feature is available to authenticated users only.
      Sign In or Create an Account ×
    • Get Citation

      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/.

      Download citation file:


      © ARVO (1962-2015); The Authors (2016-present)

      ×
  • Supplements
Abstract

Purpose: 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.

Methods: 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.

Results: 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.

Conclusions: These results indicate that 1% BHB is safe and effectiveness in the treatment of ocular surface disorder in tear-deficient dry eye patient.

Keywords: 479 cornea: clinical science  
×
×

This PDF is available to Subscribers Only

Sign in or purchase a subscription to access this content. ×

You must be signed into an individual account to use this feature.

×