Efficacy of Lycium Barbarum Polysaccharide in Dry Eye Disease Management
ConditionDry Eye Syndromes
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-60
SponsorThe Hong Kong Polytechnic University
About this trial
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
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Single group
Treatments tested in this trial
Lycium Barbarum Polysaccharide
Dietary supplementParticipants 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.
Treatment groups
30 Participants
are divided into 1 treatment groupGroup A: Lycium Barbarum Polysaccharide SupplementationExperimental treatment 1 intervention
Trial outcomes
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.
Time frame
Baseline and Week 12Secondary outcomes
1
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.
Time frame
Baseline and Week 122
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.
Time frame
Baseline and Week 123
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.
Time frame
Baseline and Week 124
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.
Time frame
Baseline and Week 12Sponsors and contacts
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Source ClinicalTrials.gov