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.
Highlights
Dry eye disease is characterised by chronic tear deficiency that has a multifactorial aetiology[1]
Concerning ocular surface disorders, we have shown that topical BHB ameliorates corneal epithelial erosion and superficial punctate keratopathy—both hallmarks of dry eye disease—in a rat model[15,16]
The most important finding of this study was that treatment with the 1% BHB ophthalmic solution significantly improved both corneal and conjunctival symptoms in patients with an impaired capacity for tear secretion
Summary
Dry eye disease is characterised by chronic tear deficiency that has a multifactorial aetiology[1]. Dry eye is commonly treated by frequently applying a viscoelastic artificial tear solution, by wearing moisture chamber spectacles, or by lacrimal punctal occlusion, which can involve either surgery or plug insertion[2]. These treatments only preserve tear fluid to prevent dehydration of the ocular surface. Many investigators have effectively managed dry eye disease using autologous serum, the composition of which resembles tears[6] This approach has been used in dry eye disease of many different causes—chronic graft-versus-host disease[7], persistent epithelial defects, vital staining of the ocular surface following laser-assisted in situ keratomileusis[8], and Sjögren syndrome[9]. We performed a subgroup analysis to investigate the relationship between initial dry eye severity and the effect of the BHB ophthalmic solution
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