Efficacy of Lycium Barbarum Polysaccharide in Dry Eye Disease Management
1 other identifier
interventional
30
1 country
1
Brief 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.Does LBP supplementation improve clinical signs of dry eye disease, such as tear film stability, tear production, and ocular surface staining?
- 3.Take LBP tablets by mouth twice daily for 12 weeks
- 4.Visit the clinic at baseline, 4 weeks, and 12 weeks for checkups and eye tests
- 5.Complete dry eye questionnaires and undergo clinical assessments of tear film, ocular surface health, and related eye measurements
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Sep 2026
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 14, 2026
CompletedFirst Submitted
Initial submission to the registry
September 15, 2026
CompletedFirst Posted
Study publicly available on registry
September 25, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
August 1, 2027
September 25, 2026
September 1, 2026
4 months
September 15, 2026
September 21, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
Baseline and Week 12
Secondary Outcomes (8)
Change in First Non-Invasive Tear Break-Up Time
Baseline and Week 12
Change in Tear Film Lipid Layer Thickness
Baseline and Week 12
Change in Tear Meniscus Height
Baseline and Week 12
Change in Corneal Sensitivity Threshold
Baseline and Week 12
Change in Schirmer Test Wetting Length
Baseline and Week 12
- +3 more secondary outcomes
Study Arms (1)
Lycium Barbarum Polysaccharide Supplementation
EXPERIMENTALParticipants will receive oral Lycium barbarum polysaccharide supplementation for 12 weeks.
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
The Hong Kong Polytechnic University, School of Optometry, Optometry Clinic
Hong Kong, Hong Kong, Hong Kong
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
September 15, 2026
First Posted
September 25, 2026
Study Start
September 14, 2026
Primary Completion (Estimated)
January 1, 2027
Study Completion (Estimated)
August 1, 2027
Last Updated
September 25, 2026
Record last verified: 2026-09
Data Sharing
- IPD Sharing
- Will not share
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.