Preventive Effect of Diospyros kaki on Intraocular Pressure and Dry Eye: A Randomized, Double-Blind, Placebo-Controlled Clinical Trial

Background

Dry eye disease (DED) is a common chronic ocular disorder associated with ocular discomfort and tear film damage. Traditional medicinal uses of Diospyros kaki leaves have been well-documented for their potent radical-scavenging, antioxidant, and immune-modulatory properties. Emerging evidence suggests that D. kaki leaves can improve various ocular conditions, including dry eye disease and elevated intraocular pressure (IOP), making it a potential therapeutic option for managing these conditions.

Methods

A randomized controlled trial was conducted involving one hundred patients diagnosed with mild DED. The participants were divided into placebo and treatment groups, receiving maltodextrin and EEDK (600 mg/day). Clinical efficacy, clinical indices, and adverse reactions were compared between the two groups.

Results

Administration of EEDK significantly improved tear film stability and corneal staining scores in patients with DED. IOP significantly decreased after EEDK administration. The EEDK group exhibited significant improvements in tear film stability compared with the placebo group at 4, 8, and 12 weeks. Consistent reductions in IOP and corneal staining scores were observed throughout the 12-week study period in the EEDK group. Moreover, EEDK intake effectively enhanced tear production as evidenced by the Schirmer test. No significant adverse events were observed.

Conclusions

The oral administration of EEDK demonstrated significant therapeutic effects in improving dry eye symptoms without notable adverse events. The results of this study suggest that EEDK could be considered an ideal therapeutic option for treating patients with dry eye disease.

Trial registration

The trial is registered with the Korean Clinical Trial Registry, KCT0010532

Highlights