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临床试验/NCT04348110
NCT04348110已完成不适用

Evaluation of Eye Health Benefits of Blueberry Chewable Tablets

TCI Co., Ltd.2 个研究点 分布在 1 个国家目标入组 57 人开始时间: 2020年4月17日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
TCI Co., Ltd.
入组人数
57
试验地点
2
主要终点
Tear break-up time (TBUT)

研究概览

简要总结

To assess the efficacy of blueberry chewable tablets on Eye Health

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
Double (Participant, Investigator)

入排标准

年龄范围
20 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Adult men and women over 20 years old
  • Use 3C products over 6 hours per day
  • Symptoms of dry eyes or tired eyes
  • Tear Break-Up Time is 10 seconds less
  • No history of ocular surgery (strabismus surgery, refractive surgery etc.)

排除标准

  • Have systemic diseases affecting the front surface of the eyes.
  • Long-term use of drugs or eye drops that affect the condition of the front surface of the eyes
  • Long-term contact lens wear

结局指标

主要结局

Tear break-up time (TBUT)

时间窗: 8 weeks

Slit lamp ocular Surface Analyzer is utilized to measure fist tear break-up time with slit lamp. Units: sec

Changes of accommodation

时间窗: 8 weeks

Speedy-I is utilized to measure the accommodative micro fluctuation test of the ciliary muscle. Units: HFC

Changes of Schirmer's test

时间窗: 8 weeks

Schirmer's test determines whether the eye produces enough tears to keep it moist. Units: mm (in 5minutes)

Changes of non-invasive tear break-up time (NITBUT)

时间窗: 8 weeks

Ocular Surface Analyzer is utilized to measure non-invasive tear break-up time. Units: sec

Changes of tear meniscus height

时间窗: 8 weeks

Slit lamp Ocular Surface Analyzer is utilized to measure tear meniscus height. Units: mm

Ocular Surface Disease Index (OSDI)

时间窗: 8 weeks

The Ocular Surface Disease Index (OSDI) is a 12-item scale for the assessment of symptoms related to dry eye disease and their effect on vision. Units: point

次要结局

  • Changes of Near point of convergence (NPC)(8 weeks)
  • Changes of eye pressure(8 weeks)
  • Changes of Stereo vision(8 weeks)
  • Changes of Amplitude of Flipper facility(8 weeks)
  • Changes of Amplitude of accommodation (AA)(8 weeks)
  • Changes of binocular motor fusion(8 weeks)
  • Changes of Fundus photography(8 weeks)
  • Changes of Intraocular pressure (IOP)(8 weeks)

研究者

发起方
TCI Co., Ltd.
申办方类型
Industry
责任方
Sponsor

研究点 (2)

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