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临床试验/ACTRN12619001520123
ACTRN12619001520123尚未招募4 期

3-month study of microbial contamination of silver contact lens storage cases in daily wear frequent replacement soft contact lens wearers.

CooperVision Inc0 个研究点目标入组 40 人开始时间: 2019年11月4日最近更新:
适应症

试验速览

阶段
4 期
状态
尚未招募
入组人数
40

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional
分配方式
Randomised controlled trial
主要目的
Treatment
盲法
Blinded (masking used)

入排标准

年龄范围
18 Years 至 o limit(—)
性别
All

入选标准

  • 1. Age 18 years or older at the time of screening.
  • 2. Be a current frequent replacement soft contact lens wearer (hydrogel or silicone hydrogel)
  • 3. Be willing to wear the contact lenses on a daily wear basis for a minimum of 4 days per week for the duration of the study and follow standard contact lens practice and precautions during lens wear
  • 4. Be willing to use the study prescribed contact lens cleaning and disinfection solution and lens storage case for the duration of the study

排除标准

  • 1. Daily disposable or extended wear soft contact lens wearer
  • 2. Rigid gas permeable lens wearer (including orthokeratology).
  • 3. Any ocular or systemic allergies or diseases that may interfere with contact lens wear.
  • 4. Any autoimmune disease or use of medication, which may interfere with contact lens wear. Habitual medications used by successful soft contact lens wearers are considered acceptable.
  • 5. Any ocular abnormalities such as entropion, ectropion, extrusions, chalazia, recurrent styes, history of recurrent corneal erosions.
  • 6. Any previous, or planned, ocular or interocular surgery (e.g., radial keratotomy, PRK, LASIK, etc.).
  • 7. Participation in any contact lens or lens care product clinical trial within 14 days prior to study enrolment.
  • 8. Any infectious disease (e.g., hepatitis, tuberculosis) or contagious immunosuppressive diseases (e.g., HIV) by self-report.
  • 9. Be currently pregnant or breastfeeding

研究者

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