NCT02802150

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2015

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2015

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2015

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2016

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

February 17, 2016

Completed
4 months until next milestone

First Posted

Study publicly available on registry

June 16, 2016

Completed
Last Updated

June 16, 2016

Status Verified

June 1, 2016

Enrollment Period

5 months

First QC Date

February 17, 2016

Last Update Submit

June 13, 2016

Conditions

Dry Eye Syndromes

Keywords

Zanthoxylum schinifolium seed Oilsoy bean oilomega-3 fatty aciddry eye disease

Outcome Measures

Primary Outcomes (4)

  • 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 Outcomes (10)

  • change from interleukin-13(pg/mL)

    baseline, 10 weeks

  • change from interferon-gamma(pg/mL)

    baseline, 10 weeks

  • change from interleukin-1β(pg/mL)

    baseline, 10 weeks

  • change from interleukin-17(pg/mL)

    baseline, 10 weeks

  • change from malondialdehyde(nU/L)

    baseline, 10 weeks

  • +5 more secondary outcomes

Other Outcomes (1)

  • change from fatty acid composition of erythrocyte membrane

    baseline, 10 weeks

Study Arms (2)

Zanthoxylum schinifolium seed Oil

ACTIVE COMPARATOR

Zanthoxylum schinifolium seed Oil 100% (4g/day)

Dietary Supplement: Zanthoxylum Schinifolium Seed Oil(4g/day)

soy bean oil

PLACEBO COMPARATOR

soy bean oil 99.9%, edible dyes 0.01% (4g/day)

Dietary Supplement: Soy Bean Oil;placebo(4g/day)

Interventions

Zanthoxylum Schinifolium Seed Oil(4g/day)DIETARY_SUPPLEMENT

parallel design

Zanthoxylum schinifolium seed Oil
Soy Bean Oil;placebo(4g/day)DIETARY_SUPPLEMENT

parallel design

soy bean oil

Eligibility Criteria

Age20 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • men and women
  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Clinical Trial Center for Functional Foods; Chonbuk National University Hospital

Jeonju, Jeollabuk-do, 560-822, South Korea

Location

Clinical Trial Center for Functional Foods

Jeonju, Jeollabuk-do, 560-822, South Korea

Location

MeSH Terms

Conditions

Dry Eye Syndromes

Condition Hierarchy (Ancestors)

Lacrimal Apparatus DiseasesEye Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
M.D., Ph.D.

Study Record Dates

First Submitted

February 17, 2016

First Posted

June 16, 2016

Study Start

February 1, 2015

Primary Completion

July 1, 2015

Study Completion

February 1, 2016

Last Updated

June 16, 2016

Record last verified: 2016-06

Locations

KR(2)