Dry Eye Syndromes
Conditions
Keywords
Zanthoxylum schinifolium seed Oil, soy bean oil, omega-3 fatty acid, dry eye disease
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.
Interventions
DIETARY_SUPPLEMENTZanthoxylum Schinifolium Seed Oil(4g/day)
parallel design
DIETARY_SUPPLEMENTSoy Bean Oil;placebo(4g/day)
parallel design
Sponsors
Chonbuk National University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
20 Years to 70 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| change from ocular surface disease index(0 to 100 score) | baseline, 5weeks, 10 weeks | Measures to assess differences baseline and after the 5-weeks and 10-weeks |
| change from corneal staining(0 to 5 grade) | baseline, 5weeks, 10 weeks | Measures to assess differences baseline and after the 5-week and 10-week |
| change from Schirmer test(mm) | baseline, 5weeks, 10 weeks | Measures to assess differences baseline and after the 5-week and 10-week intervention period |
| change from tear break-up time(seconds) | baseline, 5weeks, 10 weeks | Measures to assess differences baseline and after the 5-week and 10-week |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| change from interleukin-17(pg/mL) | baseline, 10 weeks | Measures to assess differences baseline and after the 10-weeks |
| change from malondialdehyde(nU/L) | baseline, 10 weeks | Measures to assess differences baseline and after the 10-weeks |
| change from low-density lipoprotein(pmol/mg) | baseline, 10 weeks | Measures to assess differences baseline and after the 10-weeks |
| change from triglyceride(mg/dL) | baseline, 10 weeks | Measures to assess differences baseline and after the 10-weeks |
| change from high-density lipoprotein cholesterol(mg/dL) | baseline, 10 weeks | Measures to assess differences baseline and after the 10-weeks |
| change from low-density lipoprotein cholesterol(mg/dL) | baseline, 10 weeks | Measures to assess differences baseline and after the 10-weeks |
| change from total cholesterol(mg/dL) | baseline, 10 weeks | Measures to assess differences baseline and after the 10-weeks |
| change from interleukin-13(pg/mL) | baseline, 10 weeks | Measures to assess differences baseline and after the 10-weeks |
| change from interferon-gamma(pg/mL) | baseline, 10 weeks | Measures to assess differences baseline and after the 10-weeks |
| change from interleukin-1β(pg/mL) | baseline, 10 weeks | Measures to assess differences baseline and after the 10-weeks |
Other
| Measure | Time frame | Description |
|---|---|---|
| change from fatty acid composition of erythrocyte membrane | baseline, 10 weeks | 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. |
Countries
South Korea
Outcome results
None listed