Dry Eye SyndromesNCT07842536
Efficacy of Lycium Barbarum Polysaccharide in Dry Eye Disease Management
A study testing Lycium Barbarum Polysaccharide in people with Dry Eye Syndromes, run by The Hong Kong Polytechnic University at 1 site in Hong Kong.
Trial summary
The goal of this pilot clinical study is to learn if Lycium barbarum polysaccharide (LBP) supplementation helps manage dry eye disease in adults. It will also learn about the safety of LBP supplementation. The main questions it aims to answer are: 1. Does LBP supplementation improve dry eye symptoms after 12 weeks? 2. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Dry Eye Syndromes
- What is being tested?
- Lycium Barbarum Polysaccharide
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteHong Kong
- Study dates
- 14 Sep 2026to 1 Aug 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age 18 to 60 years at enrollment.
- Clinical diagnosis of dry eye disease, defined as OSDI-12 score >=13 and at least one clinical sign of dry eye disease.
- Habitual visual acuity 6/9 or better in both eyes.
- Able to understand the study procedures and provide written informed consent.
Who cannot join
- Ocular infection within 3 months before enrollment or ocular disease other than dry eye disease.
- History of ocular surgery, including refractive surgery.
- Use of dry eye-related products, such as artificial tears, within 1 month before enrollment.
- Contact lens wear within 1 month before enrollment.
- Long-term use of medications known to affect dry eye symptoms.
- Severe or unstable systemic disease.
Show all 10Show fewer
- Infectious disease, such as viral influenza.
- Known allergy or hypersensitivity to Lycium barbarum polysaccharide.
- Pregnant or breastfeeding.
- Any condition that, in the investigator's judgment, makes the participant unsuitable for the study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Hong Kong1 site, 1 recruiting
- Recruiting
The Hong Kong Polytechnic University, School of Optometry, Optometry Clinic
Hong Kong, Hong Kong
About this study
Official title: Efficacy of Lycium Barbarum Polysaccharide in Dry Eye Disease Management : A Pilot Study
The goal of this pilot clinical study is to learn if Lycium barbarum polysaccharide (LBP) supplementation helps manage dry eye disease in adults. It will also learn about the safety of LBP supplementation.
The main questions it aims to answer are:
Read more
- Does LBP supplementation improve dry eye symptoms after 12 weeks?
- Does LBP supplementation improve clinical signs of dry eye disease, such as tear film stability, tear production, and ocular surface staining?
Researchers will evaluate changes in dry eye symptoms and eye examination results before and after LBP supplementation.
Participants will:
- Take LBP tablets by mouth twice daily for 12 weeks
- Visit the clinic at baseline, 4 weeks, and 12 weeks for checkups and eye tests
- Complete dry eye questionnaires and undergo clinical assessments of tear film, ocular surface health, and related eye measurements
Read the detailed description
Dry eye disease is associated with disruption of tear film homeostasis, ocular surface inflammation, and ocular discomfort. Current management often includes lubricating eye drops and other supportive approaches, but additional interventions that may support ocular surface health remain of interest.
Lycium barbarum polysaccharide is a bioactive component derived from goji berry. Previous laboratory and animal studies suggest that it may have antioxidant, anti-inflammatory, and neuroprotective effects relevant to ocular surface disease. However, clinical data on its use in people with dry eye disease are limited.
This pilot study will generate preliminary clinical information on oral Lycium barbarum polysaccharide supplementation in adults with dry eye disease. The study will use standardized optometric assessments in a clinical research setting to characterize changes in dry eye-related symptoms and ocular surface findings over the study period.
Information from this pilot study may help determine whether further investigation of Lycium barbarum polysaccharide supplementation in dry eye disease is warranted in a larger controlled trial.
- Conditions
- Dry Eye Syndromes
- Being tested
- Lycium Barbarum Polysaccharide
- Keywords
- Lycium barbarum polysaccharide, LBP, Goji berry, Ocular surface disease, Ocular Surface Disease Index, Dietary supplementation, Dry eye disease, Pilot clinical study
- 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.
Lycium Barbarum PolysaccharideDietary supplement
Also called LBP, Goji glycoconjugates, Viso I
Participants will take Lycium barbarum polysaccharide tablets orally for 12 weeks. The dosing regimen is two tablets twice daily, for a total of four tablets per day. Each tablet contains Lycium barbarum glycoconjugates, blueberry powder, and grape seed extract.
| Study group | Role | What they receive |
|---|---|---|
| Lycium Barbarum Polysaccharide Supplementation | Experimental | Participants will receive oral Lycium barbarum polysaccharide supplementation for 12 weeks. Receives: Dietary Supplement: Lycium Barbarum Polysaccharide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in 12-Item Ocular Surface Disease Index Score
The 12-item Ocular Surface Disease Index (OSDI-12) assesses dry eye symptoms. Scores range from 0 to 100, with higher scores indicating worse symptoms. Change from baseline to Week 12 will be assessed.
Measured: Baseline and Week 12
Secondary outcomes (8)
Change in First Non-Invasive Tear Break-Up Time
First non-invasive tear break-up time will be measured in seconds using the Oculus Keratograph 5M. Longer times indicate greater tear film stability. Change from baseline to Week 12 will be assessed.
Measured: Baseline and Week 12
Change in Tear Film Lipid Layer Thickness
Tear film lipid layer thickness will be measured in nanometers using the IDRA Ocular Surface Analyzer. Change from baseline to Week 12 will be assessed.
Measured: Baseline and Week 12
Change in Tear Meniscus Height
Lower tear meniscus height will be measured in millimeters using the Oculus Keratograph 5M. Change from baseline to Week 12 will be assessed.
Measured: Baseline and Week 12
Change in Corneal Sensitivity Threshold
Corneal sensitivity threshold will be measured in millibars using the Brill non-contact corneal esthesiometer. Lower thresholds indicate greater corneal sensitivity. Change from baseline to Week 12 will be assessed.
Measured: Baseline and Week 12
Change in Schirmer Test Wetting Length
Tear production will be assessed using the Schirmer test, with strip wetting length recorded in millimeters after 5 minutes. Greater wetting length indicates greater tear production. Change from baseline to Week 12 will be assessed.
Measured: Baseline and Week 12
Change in Visual Acuity
Monocular visual acuity will be measured using a standard visual acuity chart and recorded as a Snellen fraction. Follow-up testing will use the baseline objective refraction, where available; otherwise, habitual visual acuity will be used. Change from baseline to Week 12 will be assessed.
Measured: Baseline and Week 12
Change in National Eye Institute Corneal Fluorescein Staining Score
Corneal fluorescein staining will be graded using the National Eye Institute scale, with total scores ranging from 0 to 15 per eye. Higher scores indicate more severe staining. Change from baseline to Week 12 will be assessed.
Measured: Baseline and Week 12
Change in National Eye Institute Conjunctival Lissamine Green Staining Score
Conjunctival lissamine green staining will be graded using the National Eye Institute scale, with total scores ranging from 0 to 18 per eye. Higher scores indicate more severe staining. Change from baseline to Week 12 will be assessed.
Measured: Baseline and Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2026
- Study start14 Sep 2026 (estimated)
- Primary completion1 Jan 2027 (estimated)
- Study completion1 Aug 2027 (estimated)
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.
- More trials run by The Hong Kong Polytechnic UniversityThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Hong Kong Polytechnic University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, LAM Chuen Thomas, FAAO, PhD, The Hong Kong Polytechnic University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07842536
- Sponsor's protocol ID
- 20260106003
- Status last verified
- Sep 2026
- First submitted
- 15 Sep 2026
- Last updated
- 25 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is currently no plan to share individual participant data. Researchers may contact the corresponding author with data-related inquiries. Any future sharing would require review by the study team and compliance with applicable ethics and institutional requirements.
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Lycium Barbarum Polysaccharide in Dry Eye Disease Management : A Pilot Study
- ClinicalTrials.gov ID
- NCT07842536
- Acronym / sponsor ID
- 20260106003
- Conditions
- Dry Eye Syndromes
- Keywords
- Lycium barbarum polysaccharide, LBP, Goji berry, Ocular surface disease, Ocular Surface Disease Index, Dietary supplementation, Dry eye disease, Pilot clinical study
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- The Hong Kong Polytechnic UniversityUniversity, hospital or other
- Study start
- 14 Sep 2026 (estimated)
- Primary completion
- 1 Jan 2027 (estimated)
- Study completion
- 1 Aug 2027 (estimated)
- First posted
- 25 Sep 2026 (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 pilot clinical study is to learn if Lycium barbarum polysaccharide (LBP) supplementation helps manage dry eye disease in adults. It will also learn about the safety of LBP supplementation.
The main questions it aims to answer are:
- Does LBP supplementation improve dry eye symptoms after 12 weeks?
- Does LBP supplementation improve clinical signs of dry eye disease, such as tear film stability, tear production, and ocular surface staining?
Researchers will evaluate changes in dry eye symptoms and eye examination results before and after LBP supplementation.
Participants will:
- Take LBP tablets by mouth twice daily for 12 weeks
- Visit the clinic at baseline, 4 weeks, and 12 weeks for checkups and eye tests
- Complete dry eye questionnaires and undergo clinical assessments of tear film, ocular surface health, and related eye measurements
Detailed description
Dry eye disease is associated with disruption of tear film homeostasis, ocular surface inflammation, and ocular discomfort. Current management often includes lubricating eye drops and other supportive approaches, but additional interventions that may support ocular surface health remain of interest.
Lycium barbarum polysaccharide is a bioactive component derived from goji berry. Previous laboratory and animal studies suggest that it may have antioxidant, anti-inflammatory, and neuroprotective effects relevant to ocular surface disease. However, clinical data on its use in people with dry eye disease are limited.
This pilot study will generate preliminary clinical information on oral Lycium barbarum polysaccharide supplementation in adults with dry eye disease. The study will use standardized optometric assessments in a clinical research setting to characterize changes in dry eye-related symptoms and ocular surface findings over the study period.
Information from this pilot study may help determine whether further investigation of Lycium barbarum polysaccharide supplementation in dry eye disease is warranted in a larger controlled trial.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Lycium Barbarum Polysaccharide Supplementation | Experimental | Dietary Supplement: Lycium Barbarum PolysaccharideParticipants will receive oral Lycium barbarum polysaccharide supplementation for 12 weeks. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Age 18 to 60 years at enrollment.
- Clinical diagnosis of dry eye disease, defined as OSDI-12 score >=13 and at least one clinical sign of dry eye disease.
- Habitual visual acuity 6/9 or better in both eyes.
- Able to understand the study procedures and provide written informed consent.
Key exclusion criteria (10 listed)
- Ocular infection within 3 months before enrollment or ocular disease other than dry eye disease.
- History of ocular surgery, including refractive surgery.
- Use of dry eye-related products, such as artificial tears, within 1 month before enrollment.
- Contact lens wear within 1 month before enrollment.
- Long-term use of medications known to affect dry eye symptoms.
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 |
|---|---|---|
| Lycium Barbarum PolysaccharideAlso: LBP, Goji glycoconjugates, Viso IParticipants will take Lycium barbarum polysaccharide tablets orally for 12 weeks. The dosing regimen is two tablets twice daily, for a total of four tablets per day. Each tablet contains Lycium barbarum glycoconjugates, blueberry powder, and grape seed extract. | Dietary supplement | Lycium Barbarum Polysaccharide Supplementation |
Primary outcome
Change in 12-Item Ocular Surface Disease Index Score
Time frame: Baseline and Week 12
The 12-item Ocular Surface Disease Index (OSDI-12) assesses dry eye symptoms. Scores range from 0 to 100, with higher scores indicating worse symptoms. Change from baseline to Week 12 will be assessed.
8 secondary outcomes
Change in First Non-Invasive Tear Break-Up Time
Time frame: Baseline and Week 12
Change in Tear Film Lipid Layer Thickness
Time frame: Baseline and Week 12
Change in Tear Meniscus Height
Time frame: Baseline and Week 12
Change in Corneal Sensitivity Threshold
Time frame: Baseline and Week 12
Change in Schirmer Test Wetting Length
Time frame: Baseline and Week 12
Change in Visual Acuity
Time frame: Baseline and Week 12
Change in National Eye Institute Corneal Fluorescein Staining Score
Time frame: Baseline and Week 12
Change in National Eye Institute Conjunctival Lissamine Green Staining Score
Time frame: Baseline and Week 12
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2026.
- Individual participant dataSharing planned: No. There is currently no plan to share individual participant data. Researchers may contact the corresponding author with data-related inquiries. Any future sharing would require review by the study team and compliance with applicable ethics and institutional requirements.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lycium Barbarum Polysaccharide in people with Dry Eye Syndromes, run by The Hong Kong Polytechnic University at 1 site in Hong Kong.
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 10 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: looking for participants now, as of the sponsor's last update on 25 Sep 2026. 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 Hong Kong. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Thomas C LAM, PhD (+852 27666115, thomas.c.lam@polyu.edu.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in 12-Item Ocular Surface Disease Index Score (time frame: Baseline and Week 12). 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 25 Sep 2026.