Clinical trial NCT02802150: The Effect of Oral Zanthoxylum Schinifolium Seed Oil in Individuals With Dry Eye Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dry Eye Syndromes
Keywords: Zanthoxylum schinifolium seed Oil
soy bean oil
omega-3 fatty acid
dry eye disease
Lead sponsor: Chonbuk National University Hospital
Sponsor class: OTHER
First posted: 2016-06-16
Enrollment: 20
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: change from Schirmer test(mm)
timeFrame: baseline, 5weeks, 10 weeks
measure: change from tear break-up time(seconds)
timeFrame: baseline, 5weeks, 10 weeks
measure: change from corneal staining(0 to 5 grade)
timeFrame: baseline, 5weeks, 10 weeks
measure: change from ocular surface disease index(0 to 100 score)
timeFrame: baseline, 5weeks, 10 weeks
Secondary outcomes:
measure: change from interleukin-13(pg/mL)
timeFrame: baseline, 10 weeks
measure: change from interferon-gamma(pg/mL)
timeFrame: baseline, 10 weeks
measure: change from interleukin-1β(pg/mL)
timeFrame: baseline, 10 weeks
measure: change from interleukin-17(pg/mL)
timeFrame: baseline, 10 weeks
measure: change from malondialdehyde(nU/L)
timeFrame: baseline, 10 weeks
measure: change from low-density lipoprotein(pmol/mg)
timeFrame: baseline, 10 weeks
measure: change from total cholesterol(mg/dL)
timeFrame: baseline, 10 weeks
measure: change from triglyceride(mg/dL)
timeFrame: baseline, 10 weeks
measure: change from high-density lipoprotein cholesterol(mg/dL)
timeFrame: baseline, 10 weeks
measure: change from low-density lipoprotein cholesterol(mg/dL)
timeFrame: baseline, 10 weeks
Other outcomes:
measure: change from fatty acid composition of erythrocyte membrane
timeFrame: baseline, 10 weeks
Locations:
city: Jeonju
country: Korea, Republic of
facility: Clinical Trial Center for Functional Foods; Chonbuk National University Hospital
state: Jeollabuk-do
city: Jeonju
country: Korea, Republic of
facility: Clinical Trial Center for Functional Foods
state: Jeollabuk-do
Study officials:
References: