Efficacy of Lycium Barbarum Polysaccharide in Dry Eye Disease Management
Dry Eye Syndromes
What this study involves
The registry says this study is recruiting. Individual locations may have different availability.
- Study type
- Interventional
- Phase
- Not applicable
- Age range
- 18 years - 60 years
- Sex eligible
- All sexes
- Healthy volunteers
- Not accepted
- Participants
- 30 Estimated
These are starting points, not an eligibility decision. The research team must review the full requirements.
About the research
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. 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:
1. Take LBP tablets by mouth twice daily for 12 weeks
2. Visit the clinic at baseline, 4 weeks, and 12 weeks for checkups and eye tests
3. Complete dry eye questionnaires and undergo clinical assessments of tear film, ocular surface health, and related eye measurements
Read the full 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.
Who may be able to participate?
The list below is the sponsor’s full registry wording. It can include conditions, prior treatment, test results and other requirements. A match in search does not mean you qualify.
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
- 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.
Treatment, groups and participation
The registry may describe treatments and study duration without a complete visit calendar. Ask the study team for the exact schedule, procedures, risks, costs and alternatives. Keep your usual care plan unless your treating clinician tells you otherwise.
- Assignment
- Not applicable
- Masking
- No masking
Lycium Barbarum Polysaccharide Supplementation
Participants will receive oral Lycium barbarum polysaccharide supplementation for 12 weeks.
Dietary Supplement: Lycium Barbarum Polysaccharide
Lycium Barbarum Polysaccharide DIETARY_SUPPLEMENT
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.
What researchers are measuring
Outcome measures describe what is being studied. They are not proof that a treatment works.
Primary measures
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.
Secondary measures
Change in First Non-Invasive Tear Break-Up Time
Time frame: Baseline and Week 12
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.
Change in Tear Film Lipid Layer Thickness
Time frame: Baseline and Week 12
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.
Change in Tear Meniscus Height
Time frame: Baseline and Week 12
Lower tear meniscus height will be measured in millimeters using the Oculus Keratograph 5M. Change from baseline to Week 12 will be assessed.
Change in Corneal Sensitivity Threshold
Time frame: Baseline and Week 12
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.
Change in Schirmer Test Wetting Length
Time frame: Baseline and Week 12
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.
Change in Visual Acuity
Time frame: Baseline and Week 12
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.
Change in National Eye Institute Corneal Fluorescein Staining Score
Time frame: Baseline and Week 12
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.
Change in National Eye Institute Conjunctival Lissamine Green Staining Score
Time frame: Baseline and Week 12
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.
Review the complete result tables and limitations in the official record.
Open official results ↗Research locations (1)
The overall study status and a local site’s status can differ. Confirm that location’s availability before traveling.
1 locations
The Hong Kong Polytechnic University, School of Optometry, Optometry ClinicHong Kong, Hong Kong, Hong KongRecruiting
Study team and timeline
- Lead sponsor
- The Hong Kong Polytechnic University
- Study start
- Sep 14, 2026 Actual
- Primary completion
- Jan 1, 2027 Estimated
- Study completion
- Aug 1, 2027 Estimated
- First posted
- Sep 25, 2026 Actual
- Last updated
- Nov 10, 2026 Actual
Official study contacts
Official study title
Efficacy of Lycium Barbarum Polysaccharide in Dry Eye Disease Management : A Pilot Study
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Source: ClinicalTrials.gov API v2. Information is submitted by sponsors and investigators. NLM does not approve the safety or science of all listed studies. Registry disclaimer.
Retrieved: Nov 12, 2026 · Last registry update: Nov 10, 2026