Overview
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:
- Does LBP supplementation improve dry eye symptoms after 12 weeks?
- 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:
- Take LBP tablets by mouth twice daily for 12 weeks
- Visit the clinic at baseline, 4 weeks, and 12 weeks for checkups and eye tests
- Complete dry eye questionnaires and undergo clinical assessments of tear film, ocular surface health, and related eye measurements
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.
Eligibility
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.
