跳至主要内容
临床试验/NCT04031118
NCT04031118已完成不适用

Corneal Oxygen Uptake With Apioc Contact Lenses

Lentechs, LLC2 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2019年7月15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
Lentechs, LLC
入组人数
20
试验地点
2
主要终点
Corneal Oxygen Uptake Rate

研究概览

简要总结

The purpose of this research is to determine if a new investigational contact lens shape allows the eye to get more oxygen.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Device Feasibility
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 45 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Provide informed consent.
  • Appear willing and able to adhere to instructions set forth in the protocol.
  • Be between the ages of 18 and
  • Be an experienced contact lens wearer.
  • Be an eyecare clinician or clinician-in-training.
  • Flat and steep keratometry readings within 40 to 50D.
  • Clear, healthy corneas with no irregular astigmatism.
  • Normal, healthy conjunctiva in both eyes.
  • Be able to provide corneal topography measurements.
  • Be able to provide manifest refraction measurements.

排除标准

  • Irregular corneal astigmatism.
  • Use of topical or systemic antihistamines within the previous week.
  • Use of topical ophthalmic drops within the previous two days.
  • History of corneal surgery.
  • Currently pregnant or lactating.
  • Systemic disease that would interfere with contact lens wear.
  • Previous diagnosis of dry eye syndrome.

结局指标

主要结局

Corneal Oxygen Uptake Rate

时间窗: up to 45 seconds

uptake of oxygen by human cornea in vivo

次要结局

未报告次要终点

研究者

发起方
Lentechs, LLC
申办方类型
Industry
责任方
Sponsor

研究点 (2)

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