Dry Eye Syndrome (DES)DESNCT06738446
Dietary Supplementation on Tear Secretion and Inflammation in DES
A study testing Multicomponent dietary supplement group in people with Dry Eye Syndrome (DES), run by Shih Chien Huang at 1 site in Taiwan.
Trial summary
The goal of this clinical trial is to explore the effect of supplementation of fish oil, lutein and zeaxanthin on the symptoms of dry eye syndrome, antioxidant capacity, oxidative stress and anti-inflammatory capacity in DES patients., it aims to answer are: To evaluate the effects of a 12-week multicomponent dietary… Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Dry Eye Syndrome (DES)
- What is being tested?
- Multicomponent dietary supplement group
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteTaiwan
- Study dates
- 27 Sep 2021to 14 Jun 2022
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- aged between 20 and 80 years,
- moderate or above severity of dry eye syndrome.
Who cannot join
- undergoing ophthalmic surgery within the past three months,
- autoimmune diseases,
- ocular allergies,
- consumption of fish oil or antioxidant supplements within the past three months, and
- pregnant or lactating women.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Multicomponent Dietary Supplementation: Impact on Tear Secretion and Ocular Surface Inflammation in Dry Eye Syndrome Patients
The goal of this clinical trial is to explore the effect of supplementation of fish oil, lutein and zeaxanthin on the symptoms of dry eye syndrome, antioxidant capacity, oxidative stress and anti-inflammatory capacity in DES patients., it aims to answer are:
To evaluate the effects of a 12-week multicomponent dietary supplementation (capsule content are eicosapentaenoic acid 45 mg, docosahexaenoic acid 30 mg, lutein 30 mg, and zeaxanthin1.8 mg)on symptoms of dry eye syndrome, oxidative stress, antioxidant capacity, and inflammation.
Read more
To investigate the relationships between dry eye symptoms, oxidative stress, antioxidant capacity, and inflammation.
Participants will be randomly assigned to control group (n = 50) and supplement group (n = 50) and white pomegranate extract group (n = 50) for 12 weeks. Participants will complete assessments of tear secretion, antioxidant capacity, and ocular surface inflammation.
Read the detailed description
- Study Participants i. Inclusion criteria: (1) Aged 20 to 80 years; (2) Diagnosed with moderate or greater dry eye syndrome by an ophthalmologist. ii. Exclusion criteria: Previous ocular surgery within the last 3 months. iii. Withdrawal Criteria Participants are free to decide whether to participate in this trial, and they can withdraw their consent at any time during the trial without providing any reason. If participants experience discomfort, they may withdraw from the trial at any time without facing any penalties or compromising their rights. iv. Participants were randomly assigned to a supplement group or control group. Participants in supplement group were asked to take a capsule content are eicosapentaenoic acid 45 mg, docosahexaenoic acid 30 mg, lutein 30 mg, and zeaxanthin1.8 mg every day for 12 weeks.
- Subject Recruitment Interested participants will be recruited openly through posters posted at Chung Shan Medical University Hospital. The researchers will explain the trial content for 15-20 minutes, and if interested, participants will sign the informed consent form.
- Research Methods At weeks 0 and 12 of the trial, 10 μL of tear samples and 10 mL of blood samples will be collected from participants.
- The basic and OSDI questionnaires and ii. Evaluate dry eye-related indicators evaluation iii. Measure blood or tear oxidative stress and antioxidant capacity, and tear inflammatory factors were measured.
- All statistical data will be analyzed using SigmaPlot statistical software (version 12.5; Systat Software, San Jose, CA), and the data will be presented using an intention-to-treat (ITT) approach. The differences in continuous data between the two groups will be compared using the Student's t-test. The differences in values within the group before and after intervention will be compared using the paired t-test. The differences in ordinal data between the two groups will be assessed using the Chi-square test. Partial Spearman's correlation will be used to adjust for confounding factors (age, gender, and menopause status) to explore the correlations between changes in oxidative stress and antioxidant capacity in blood and tears, changes in inflammatory factors, and changes in dry eye assessment. Multiple linear regression will be used to analyze the effect of supplement intake on changes in oxidative stress and antioxidant capacity in blood and tears, changes in inflammatory factors, and changes in dry eye assessment. The data will be expressed as mean ± standard deviation (SD), with p < 0.05 indicating statistical significance.
Through this study, the administration of multicomponent dietary supplementation to patients with dry eye syndrome aims to understand whether different eye health nutrients improve tear secretion, antioxidant capacity, and anti-inflammatory responses. This may serve as an adjunctive treatment or symptom relief for dry eye syndrome.
- Conditions
- Dry Eye Syndrome (DES)
- Being tested
- Multicomponent dietary supplement group
- Keywords
- Dry eye syndrome, inflammation, oxidative stress, fish oil, lutein, zeaxanthin
- Medical subject headings
- Dry Eye Syndromes, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multicomponent dietary supplement groupDietary supplement
Participants in supplement group were asked to take a capsule content are eicosapentaenoic acid 45 mg, docosahexaenoic acid 30 mg, lutein 30 mg, and zeaxanthin1.8 mg every day for 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| control group | No intervention | This group is used only as a control. |
| Multicomponent Dietary Supplement group | Experimental | 45 mg/day EPA, 30 mg/day DHA, 30 mg/day lutein, and 1.8 mg/day zeaxanthin Receives: Dietary Supplement: Multicomponent dietary supplement group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ocular Surface Disease Index
We aim to improve the symptoms of dry eye disease in patients by administering dietary supplements
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2024
- Study start27 Sep 2021
- Primary completion2 Apr 2022
- Study completion14 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dry Eye Syndrome (DES)Studies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shih Chien Huang
- Sponsor type
- University, hospital or other
- Collaborators
- Far East Bio-Tec Co., Ltd
- Responsible party
- Sponsor-investigator, Shih Chien Huang, Chung Shan Medical University
- Investigators
- Shih-Chien Huang, Dr, Study chair, Chung Shan Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06738446
- Sponsor's protocol ID
- CSI-20199
- Acronym
- DES
- Status last verified
- May 2025
- First submitted
- 12 Dec 2024
- Last updated
- 14 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicomponent Dietary Supplementation: Impact on Tear Secretion and Ocular Surface Inflammation in Dry Eye Syndrome Patients
- ClinicalTrials.gov ID
- NCT06738446
- Acronym / sponsor ID
- DES / CSI-20199
- Conditions
- Dry Eye Syndrome (DES)
- Keywords
- Dry eye syndrome, inflammation, oxidative stress, fish oil, lutein, zeaxanthin
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Shih Chien HuangUniversity, hospital or other
- Collaborators
- Far East Bio-Tec Co., Ltd
- Study start
- 27 Sep 2021 (actual)
- Primary completion
- 2 Apr 2022 (actual)
- Study completion
- 14 Jun 2022 (actual)
- First posted
- 17 Dec 2024 (actual)
- 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 goal of this clinical trial is to explore the effect of supplementation of fish oil, lutein and zeaxanthin on the symptoms of dry eye syndrome, antioxidant capacity, oxidative stress and anti-inflammatory capacity in DES patients., it aims to answer are:
To evaluate the effects of a 12-week multicomponent dietary supplementation (capsule content are eicosapentaenoic acid 45 mg, docosahexaenoic acid 30 mg, lutein 30 mg, and zeaxanthin1.8 mg)on symptoms of dry eye syndrome, oxidative stress, antioxidant capacity, and inflammation.
To investigate the relationships between dry eye symptoms, oxidative stress, antioxidant capacity, and inflammation.
Participants will be randomly assigned to control group (n = 50) and supplement group (n = 50) and white pomegranate extract group (n = 50) for 12 weeks. Participants will complete assessments of tear secretion, antioxidant capacity, and ocular surface inflammation.
Detailed description
- Study Participants i. Inclusion criteria: (1) Aged 20 to 80 years; (2) Diagnosed with moderate or greater dry eye syndrome by an ophthalmologist. ii. Exclusion criteria: Previous ocular surgery within the last 3 months. iii. Withdrawal Criteria Participants are free to decide whether to participate in this trial, and they can withdraw their consent at any time during the trial without providing any reason. If participants experience discomfort, they may withdraw from the trial at any time without facing any penalties or compromising their rights. iv. Participants were randomly assigned to a supplement group or control group. Participants in supplement group were asked to take a capsule content are eicosapentaenoic acid 45 mg, docosahexaenoic acid 30 mg, lutein 30 mg, and zeaxanthin1.8 mg every day for 12 weeks.
- Subject Recruitment Interested participants will be recruited openly through posters posted at Chung Shan Medical University Hospital. The researchers will explain the trial content for 15-20 minutes, and if interested, participants will sign the informed consent form.
- Research Methods At weeks 0 and 12 of the trial, 10 μL of tear samples and 10 mL of blood samples will be collected from participants.
- The basic and OSDI questionnaires and ii. Evaluate dry eye-related indicators evaluation iii. Measure blood or tear oxidative stress and antioxidant capacity, and tear inflammatory factors were measured.
- All statistical data will be analyzed using SigmaPlot statistical software (version 12.5; Systat Software, San Jose, CA), and the data will be presented using an intention-to-treat (ITT) approach. The differences in continuous data between the two groups will be compared using the Student's t-test. The differences in values within the group before and after intervention will be compared using the paired t-test. The differences in ordinal data between the two groups will be assessed using the Chi-square test. Partial Spearman's correlation will be used to adjust for confounding factors (age, gender, and menopause status) to explore the correlations between changes in oxidative stress and antioxidant capacity in blood and tears, changes in inflammatory factors, and changes in dry eye assessment. Multiple linear regression will be used to analyze the effect of supplement intake on changes in oxidative stress and antioxidant capacity in blood and tears, changes in inflammatory factors, and changes in dry eye assessment. The data will be expressed as mean ± standard deviation (SD), with p < 0.05 indicating statistical significance.
Through this study, the administration of multicomponent dietary supplementation to patients with dry eye syndrome aims to understand whether different eye health nutrients improve tear secretion, antioxidant capacity, and anti-inflammatory responses. This may serve as an adjunctive treatment or symptom relief for dry eye syndrome.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| control group | No intervention | –This group is used only as a control. |
| Multicomponent Dietary Supplement group | Experimental | Dietary Supplement: Multicomponent dietary supplement group45 mg/day EPA, 30 mg/day DHA, 30 mg/day lutein, and 1.8 mg/day zeaxanthin |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- aged between 20 and 80 years,
- moderate or above severity of dry eye syndrome.
Key exclusion criteria (5 listed)
- undergoing ophthalmic surgery within the past three months,
- autoimmune diseases,
- ocular allergies,
- consumption of fish oil or antioxidant supplements within the past three months, and
- pregnant or lactating women.
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 |
|---|---|---|
| Multicomponent dietary supplement groupParticipants in supplement group were asked to take a capsule content are eicosapentaenoic acid 45 mg, docosahexaenoic acid 30 mg, lutein 30 mg, and zeaxanthin1.8 mg every day for 12 weeks | Dietary supplement | Multicomponent Dietary Supplement group |
Primary outcome
Ocular Surface Disease Index
Time frame: 12 weeks
We aim to improve the symptoms of dry eye disease in patients by administering dietary supplements
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 14 May 2025.
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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.
Shih-Chien Huang, Dr study chair
Chung Shan Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Multicomponent dietary supplement group in people with Dry Eye Syndrome (DES), run by Shih Chien Huang at 1 site in Taiwan.
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 2 inclusion and 5 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 14 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. 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. 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?
Ocular Surface Disease Index (time frame: 12 weeks). 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 14 May 2025.