Clinical Trial to Investigate the Effect of DA9301 on Tablet Computer-induced Asthenopia in Humans
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 主要终点
- Change of the modified questionnaire scores proposed by Ames et al.
研究概览
简要总结
Asthenopia or eye strain describes nonspecific symptoms of an eye when it is tired from intensive work. Vaccinium uliginosum is a flowering plant in the genus Vaccinium. This plant is native to cool temperature regions of the Northern Hemisphere. Considering its antioxidative ingredients, the extract of Vaccinium uliginosum is expected to play a significant role in treating various ocular pathologies. The investigators performed a randomized, case-controlled study in healthy subjects and investigated the protective effect of Vaccinium uliginosum extract (DA-9301) on tablet computer-induced asthenopia.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
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
- 是
入选标准
- •Healthy subject aged 20 to 65 years with more than 2 hours of daily use of a smart phone or computer including a tablet and television
排除标准
- •Ocular disease in either eye
- •Ocular surface disease
- •Best corrected visual acuity < 20/30
- •Intraocular pressure > 21 mmHg
- •Optical coherence tomography proven retinal nerve fiber defect
- •Significant cataract (lens opacities classification system III)
- •Significant entropion or ectropion
- •Significant tear drainage problem proved with fluorescein dye dilution test
- •Soft or Hard contact lens use 3 or more days a week
- •History of oral intake of health supplement designed to improve asthenopia within 4 weeks before participating this study
- •Pregnant woman
- •Systemic disease
- •Uncontrolled hypertension (systolic /diastolic blood pressure > 140/90mmHg)
- •Uncontrolled diabetes mellitus (fasting blood glucose level > 180mg/dL)
- •Rheumatoid arthritis
- •Malignant disease
- •Active hepatitis (type B and C)
- •Acute or chronic infectious disease
- •Renal disease
结局指标
主要结局
Change of the modified questionnaire scores proposed by Ames et al.
时间窗: before and immediately after tablet computer use on Day 0 and Day 29 (deviation window: Day 21-31)
次要结局
未报告次要终点
研究者
Namyi Gu
Assistant professor
DongGuk University