The Effect of Oral Zanthoxylum Schinifolium Seed Oil in Individuals With Dry Eye Disease

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.

Study Overview

• Status: Completed
• Conditions: Dry Eye Syndromes
• Intervention / Treatment: Dietary supplement: Zanthoxylum Schinifolium Seed Oil(4g/day); Dietary supplement: Soy Bean Oil;placebo(4g/day)

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.

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Jeollabuk-do
    • Jeonju, Jeollabuk-do, Korea, Republic of, 560-822
      • Clinical Trial Center for Functional Foods; Chonbuk National University Hospital
    • Jeonju, Jeollabuk-do, Korea, Republic of, 560-822
      • Clinical Trial Center for Functional Foods

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Zanthoxylum schinifolium seed Oil; Zanthoxylum schinifolium seed Oil 100% (4g/day)	Dietary supplement: Zanthoxylum Schinifolium Seed Oil(4g/day); parallel design
Placebo Comparator: soy bean oil; soy bean oil 99.9%, edible dyes 0.01% (4g/day)	Dietary supplement: Soy Bean Oil;placebo(4g/day); parallel design

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
change from Schirmer test(mm)	Measures to assess differences baseline and after the 5-week and 10-week intervention period	baseline, 5weeks, 10 weeks
change from tear break-up time(seconds)	Measures to assess differences baseline and after the 5-week and 10-week	baseline, 5weeks, 10 weeks
change from corneal staining(0 to 5 grade)	Measures to assess differences baseline and after the 5-week and 10-week	baseline, 5weeks, 10 weeks
change from ocular surface disease index(0 to 100 score)	Measures to assess differences baseline and after the 5-weeks and 10-weeks	baseline, 5weeks, 10 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
change from interleukin-13(pg/mL)	Measures to assess differences baseline and after the 10-weeks	baseline, 10 weeks
change from interferon-gamma(pg/mL)	Measures to assess differences baseline and after the 10-weeks	baseline, 10 weeks
change from interleukin-1β(pg/mL)	Measures to assess differences baseline and after the 10-weeks	baseline, 10 weeks
change from interleukin-17(pg/mL)	Measures to assess differences baseline and after the 10-weeks	baseline, 10 weeks
change from malondialdehyde(nU/L)	Measures to assess differences baseline and after the 10-weeks	baseline, 10 weeks
change from low-density lipoprotein(pmol/mg)	Measures to assess differences baseline and after the 10-weeks	baseline, 10 weeks
change from total cholesterol(mg/dL)	Measures to assess differences baseline and after the 10-weeks	baseline, 10 weeks
change from triglyceride(mg/dL)	Measures to assess differences baseline and after the 10-weeks	baseline, 10 weeks
change from high-density lipoprotein cholesterol(mg/dL)	Measures to assess differences baseline and after the 10-weeks	baseline, 10 weeks
change from low-density lipoprotein cholesterol(mg/dL)	Measures to assess differences baseline and after the 10-weeks	baseline, 10 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
change from fatty acid composition of erythrocyte membrane	Fatty acid composition(%); Palmitic (C16:0); Palmitoleic (C16:1); Stearic (C18:0); Oleic (C18:1); iso-Oleic (C18:1cis); Linoleic (C18:2); Linolenic (C18:3) --> Measures to assess differences baseline and after the 10-week intervention period.	baseline, 10 weeks

Collaborators and Investigators

• Sponsor: Chonbuk National University Hospital

Study record dates

Study Major Dates

• Study Start: February 1, 2015
• Primary Completion (Actual): July 1, 2015
• Study Completion (Actual): February 1, 2016

Study Registration Dates

• First Submitted: February 17, 2016
• First Submitted That Met QC Criteria: June 13, 2016
• First Posted (Estimate): June 16, 2016

Study Record Updates

• Last Update Posted (Estimate): June 16, 2016
• Last Update Submitted That Met QC Criteria: June 13, 2016
• Last Verified: June 1, 2016

More Information

Terms related to this study

• Keywords: omega-3 fatty acid; dry eye disease; Zanthoxylum schinifolium seed Oil; soy bean oil
• Additional Relevant MeSH Terms: Eye Diseases; Lacrimal Apparatus Diseases; Keratoconjunctivitis; Conjunctivitis; Conjunctival Diseases; Keratitis; Corneal Diseases; Dry Eye Syndromes; Keratoconjunctivitis Sicca
• Other Study ID Numbers: CTCF2_2014_SC

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED