Dry Eye SyndromesNCT02802150
The Effect of Oral Zanthoxylum Schinifolium Seed Oil in Individuals With Dry Eye Disease
A study testing Zanthoxylum Schinifolium Seed Oil(4g/day) in people with Dry Eye Syndromes, run by Chonbuk National University Hospital at 2 sites in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Dry Eye Syndromes
- What is being tested?
- Zanthoxylum Schinifolium Seed Oil(4g/day)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 2 sitesSouth Korea
- Study dates
- Feb 2015to Feb 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
South Korea2 sites
Clinical Trial Center for Functional Foods; Chonbuk National University Hospital
Jeonju, Jeollabuk-do, 560-822
Clinical Trial Center for Functional Foods
Jeonju, Jeollabuk-do, 560-822
About this study
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.
Read the 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.
- Conditions
- Dry Eye Syndromes
- Being tested
- Zanthoxylum Schinifolium Seed Oil(4g/day), Soy Bean Oil;placebo(4g/day)
- Keywords
- Zanthoxylum schinifolium seed Oil, soy bean oil, omega-3 fatty acid, dry eye disease
- Medical subject headings
- Dry Eye Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Zanthoxylum Schinifolium Seed Oil(4g/day)Dietary supplement
parallel design
Soy Bean Oil;placebo(4g/day)Dietary supplement
parallel design
| Study group | Role | What they receive |
|---|---|---|
| Zanthoxylum schinifolium seed Oil | Active comparator | Zanthoxylum schinifolium seed Oil 100% (4g/day) Receives: Dietary Supplement: Zanthoxylum Schinifolium Seed Oil(4g/day) |
| soy bean oil | Placebo comparator | soy bean oil 99.9%, edible dyes 0.01% (4g/day) Receives: Dietary Supplement: Soy Bean Oil;placebo(4g/day) |
What is being measured
The primary outcome is the main question the study is designed to answer.
change from Schirmer test(mm)
Measures to assess differences baseline and after the 5-week and 10-week intervention period
Measured: baseline, 5weeks, 10 weeks
change from tear break-up time(seconds)
Measures to assess differences baseline and after the 5-week and 10-week
Measured: 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
Measured: 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
Measured: baseline, 5weeks, 10 weeks
Secondary outcomes (10)
change from interleukin-13(pg/mL)
Measures to assess differences baseline and after the 10-weeks
Measured: baseline, 10 weeks
change from interferon-gamma(pg/mL)
Measures to assess differences baseline and after the 10-weeks
Measured: baseline, 10 weeks
change from interleukin-1β(pg/mL)
Measures to assess differences baseline and after the 10-weeks
Measured: baseline, 10 weeks
change from interleukin-17(pg/mL)
Measures to assess differences baseline and after the 10-weeks
Measured: baseline, 10 weeks
change from malondialdehyde(nU/L)
Measures to assess differences baseline and after the 10-weeks
Measured: baseline, 10 weeks
change from low-density lipoprotein(pmol/mg)
Measures to assess differences baseline and after the 10-weeks
Measured: baseline, 10 weeks
change from total cholesterol(mg/dL)
Measures to assess differences baseline and after the 10-weeks
Measured: baseline, 10 weeks
change from triglyceride(mg/dL)
Measures to assess differences baseline and after the 10-weeks
Measured: baseline, 10 weeks
change from high-density lipoprotein cholesterol(mg/dL)
Measures to assess differences baseline and after the 10-weeks
Measured: baseline, 10 weeks
change from low-density lipoprotein cholesterol(mg/dL)
Measures to assess differences baseline and after the 10-weeks
Measured: baseline, 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2016 (estimated)
- Study startFeb 2015
- Primary completionJul 2015
- Study completionFeb 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dry Eye SyndromesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chonbuk National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Soo-Wan Chae, Chonbuk National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02802150
- Sponsor's protocol ID
- CTCF2_2014_SC
- Status last verified
- Jun 2016
- First submitted
- 17 Feb 2016
- Last updated
- 16 Jun 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Oral Zanthoxylum Schinifolium Seed Oil in Individuals With Dry Eye Disease
- ClinicalTrials.gov ID
- NCT02802150
- Acronym / sponsor ID
- CTCF2_2014_SC
- Conditions
- Dry Eye Syndromes
- Keywords
- Zanthoxylum schinifolium seed Oil, soy bean oil, omega-3 fatty acid, dry eye disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Chonbuk National University HospitalUniversity, hospital or other
- Study start
- Feb 2015
- Primary completion
- Jul 2015 (actual)
- Study completion
- Feb 2016 (actual)
- First posted
- 16 Jun 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Zanthoxylum schinifolium seed Oil | Active comparator | Dietary Supplement: Zanthoxylum Schinifolium Seed Oil(4g/day)Zanthoxylum schinifolium seed Oil 100% (4g/day) |
| soy bean oil | Placebo comparator | Dietary Supplement: Soy Bean Oil;placebo(4g/day)soy bean oil 99.9%, edible dyes 0.01% (4g/day) |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Zanthoxylum Schinifolium Seed Oil(4g/day)parallel design | Dietary supplement | Zanthoxylum schinifolium seed Oil |
| Soy Bean Oil;placebo(4g/day)parallel design | Dietary supplement | soy bean oil |
Primary outcome
change from Schirmer test(mm)
Time frame: 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)
Time frame: baseline, 5weeks, 10 weeks
Measures to assess differences baseline and after the 5-week and 10-week
change from corneal staining(0 to 5 grade)
Time frame: baseline, 5weeks, 10 weeks
Measures to assess differences baseline and after the 5-week and 10-week
change from ocular surface disease index(0 to 100 score)
Time frame: baseline, 5weeks, 10 weeks
Measures to assess differences baseline and after the 5-weeks and 10-weeks
10 secondary outcomes
change from interleukin-13(pg/mL)
Time frame: baseline, 10 weeks
change from interferon-gamma(pg/mL)
Time frame: baseline, 10 weeks
change from interleukin-1β(pg/mL)
Time frame: baseline, 10 weeks
change from interleukin-17(pg/mL)
Time frame: baseline, 10 weeks
change from malondialdehyde(nU/L)
Time frame: baseline, 10 weeks
change from low-density lipoprotein(pmol/mg)
Time frame: baseline, 10 weeks
change from total cholesterol(mg/dL)
Time frame: baseline, 10 weeks
change from triglyceride(mg/dL)
Time frame: baseline, 10 weeks
change from high-density lipoprotein cholesterol(mg/dL)
Time frame: baseline, 10 weeks
change from low-density lipoprotein cholesterol(mg/dL)
Time frame: baseline, 10 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jun 2016.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Zanthoxylum Schinifolium Seed Oil(4g/day) in people with Dry Eye Syndromes, run by Chonbuk National University Hospital at 2 sites in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change from Schirmer test(mm) (time frame: baseline, 5weeks, 10 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jun 2016.