NCT07842536

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. 1.Does LBP supplementation improve dry eye symptoms after 12 weeks?
  2. 2.Does LBP supplementation improve clinical signs of dry eye disease, such as tear film stability, tear production, and ocular surface staining?
  3. 3.Take LBP tablets by mouth twice daily for 12 weeks
  4. 4.Visit the clinic at baseline, 4 weeks, and 12 weeks for checkups and eye tests
  5. 5.Complete dry eye questionnaires and undergo clinical assessments of tear film, ocular surface health, and related eye measurements

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
10mo left

Started Sep 2026

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress6%
Sep 2026Aug 2027

Study Start

First participant enrolled

September 14, 2026

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

September 15, 2026

Completed
10 days until next milestone

First Posted

Study publicly available on registry

September 25, 2026

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2027

Expected
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2027

Last Updated

September 25, 2026

Status Verified

September 1, 2026

Enrollment Period

4 months

First QC Date

September 15, 2026

Last Update Submit

September 21, 2026

Conditions

Keywords

Lycium barbarum polysaccharideLBPGoji berryOcular surface diseaseOcular Surface Disease IndexDietary supplementationDry eye diseasePilot clinical study

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

EXPERIMENTAL

Participants will receive oral Lycium barbarum polysaccharide supplementation for 12 weeks.

Dietary Supplement: Lycium Barbarum Polysaccharide

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.

Also known as: LBP, Goji glycoconjugates, Viso I
Lycium Barbarum Polysaccharide Supplementation

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

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

RECRUITING

MeSH Terms

Conditions

Dry Eye Syndromes

Interventions

lycium barbarum polysaccharide

Condition Hierarchy (Ancestors)

Lacrimal Apparatus DiseasesEye Diseases

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.

Locations