Efficacy of Lycium Barbarum Polysaccharide in Dry Eye Disease Management : A Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Change in 12-Item Ocular Surface Disease Index Score
研究概览
简要总结
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
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Lycium Barbarum Polysaccharide Supplementation
Participants will receive oral Lycium barbarum polysaccharide supplementation for 12 weeks.
干预措施: Lycium Barbarum Polysaccharide (Dietary Supplement)
结局指标
主要结局
Change in 12-Item Ocular Surface Disease Index Score
时间窗: 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.
次要结局
- 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)
- Change in Visual Acuity(Baseline and Week 12)
- Change in National Eye Institute Corneal Fluorescein Staining Score(Baseline and Week 12)
- Change in National Eye Institute Conjunctival Lissamine Green Staining Score(Baseline and Week 12)
研究者
LAM Chuen Thomas, FAAO, PhD
Associate Professor
The Hong Kong Polytechnic University