A Clinical Trial on the Efficacy of Bilberry-containing Capsules for Dry Eye Mitigation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- Change From Baseline of Ocular Surface Index at Day 31
研究概览
简要总结
This study investigates whether the oral intake of a bilberry capsule product may relieve dry eye symptoms. Participants will be aged between 20 - 65 years of age, with confirmed diagnosis of dry eye status. The participants will be assessed for several parameters and asked to take 4 bilberry capsules per day for 30 days. The parameters will include ocular surface health, tear volume, tear quality, intraocular pressure, and tear compositions. After the 30 days are completed, the participants will be assessed again for the same parameters.
详细描述
This investigation is a randomized, double-blind study. Subjects with confirmed diagnosis of dry eye are randomly assigned to group A or group B, and asked to orally intake 4 capsules of either bilberry product or placebo per day.The group A will have bilberry product for 30 days, have a 20-day washout period, and then have placebo for another 30 days. The group B will have placebo for 30 days, have a 20-day washout period, and then have bilberry product for another 30 days. All participants will be assessed for parameters, including intraocular pressure, ocular surface health, tear film breakup time (TBUT), tear volume (Schirmer's test), tear composition (Na+, K+, Cl- ions), tear osmolarity, ocular surface impression cytology, and ocular surface disease index (OSDI). The assessments are conducted immediately before the first 30-day and immediately after the second 30-day oral intake period. The parameters are used to compare and evaluate whether the bilberry product can relieve dry eye symptoms.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Participant, Care Provider)
盲法说明
Only investigators and outcomes assessors have knowledge on whether the samples given are tests or placebo.
入排标准
- 年龄范围
- 20 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •aged between 20 and 65 years
- •with Schirmer's test results between 5 - 10 mm or Tear Film Break Up Time less than 10 seconds
- •Ocular Surface Disease Index more than 25
排除标准
- •evident ocular diseases such as cornea disease, cataract, vitreous degeneration, glaucoma, and retinopathy.
- •hypertension
- •or other chronic diseases or belong to vulnerable groups(pregnancy woman, prisoner, ethical minorities, economic or educationally disadvantaged subjects, disabled individuals such as those at terminal stage of tumorigenesis, blindness, terminal ill individuals)
结局指标
主要结局
Change From Baseline of Ocular Surface Index at Day 31
时间窗: on baseline and day31
To assess the health status with Fluorescein stain. Scale ranges from 0 to 3, where grade 0 = None, 3 = Severe
Change From Baseline of Schirmer's Test Value at Day 31
时间窗: on baseline and day31
To assess tear secretion volume. The amount of tears are measured in total millimeters after 5 minutes has elapsed. Lower measurement indicates presence of dry eye disease.
Change From Baseline of Tear Film Breakup Time at Day 31
时间窗: on baseline and day31
Tear Break-Up Time is a measurement in seconds of tear film stability. The shorter the Tear Break-Up Time, the lower the tear film stability. Less than 10 seconds = dry eye disease; lower score indicates worse disease.
次要结局
- Change From Baseline of Ocular Surface Impression Cytology at Day 31(on baseline and day31)
- Change From Baseline of Ocular Surface Disease Index Score at Day 31(on baseline and day31)
- Change From Baseline of Intraocular Pressure at Day 31(on baseline and day31)
- Change From Baseline of Tear Contents at Day 31(on baseline and day31)