The purpose of this study is to evaluate the clinical efficacy and safety of 10-weeks oral consumption of Zanthoxylum schinifolium seed Oil (ZSO) in patients with mild dry eye disease.

In this double-blind, randomized and placebo-controlled trial, twenty participants experiencing dry eyes symptoms were recruited, and randomly assigned to consume 4 g/day of either ZSO or soy bean oil (SBO) as placebo for 10 weeks. All participants completed the study. Follow-ups of dry eye symptoms and objective signs, inflammatory and oxidative stress markers, and blood lipid analysis were performed.

Inclusion criteria:

• men and women
• 20 to 70 years with dry eye disease
• low tear break-up time (TBUT) (<10 seconds) or low Schirmer score (with application of local anesthetic) (<10mm for 5 min) or presence of corneal and conjunctival damage at the time of screening.
• blood level of triglyceride higher than 150 mg/dL or HDL-cholesterol less than 40 and 50 mg/dL for men and women, respectively.

Exclusion Criteria:

• under the anti-inflammatory eye drops for dry eye (topical steroid and topical cyclosporin)
• hypolipidemic medication within 3 months of study entry
• history of chronic disease
• any clinical trial using an investigative medicinal product within 2 months before the first dose of the present study
• allergic or hypersensitive to any of the ingredients in the test products.
• women who were pregnant or breast feeding
• a history of alcoholism or drug abuse or medical or psychological conditions