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NCT Number: NCT07842536

Efficacy of Lycium Barbarum Polysaccharide in Dry Eye Disease Management

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

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Key information

Conditions

Dry Eye Syndromes Eye Diseases Lacrimal Apparatus Diseases

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Hong Kong Polytechnic University, School of Optometry, Optometry Clinic

Hong Kong

Location status: Recruiting

About this study

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 can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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 and study plan

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.

Other names: LBP, Goji glycoconjugates, Viso I

Primary outcomes

  1. 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 outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

Interested in participating?

Recruiting

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Sponsors and collaborators

Lead sponsor

The Hong Kong Polytechnic University

Other

Registry information

Official study title

Efficacy of Lycium Barbarum Polysaccharide in Dry Eye Disease Management : A Pilot Study

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Sep 25, 2026
Registry last updated
Sep 25, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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