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临床试验/ISRCTN10063734
ISRCTN10063734终止未知

A clinical trial to investigate the clinical performance and safety of Hydroxypropyl-Beta-Cyclodextrin 10% w/v Eye drops In the treAtment of dry eye disease

Warneford Healthcare Ltd.0 个研究点目标入组 11 人开始时间: 2019年3月4日最近更新:
适应症

试验速览

阶段
未知
状态
终止
发起方
入组人数
11

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional

入排标准

性别
All

入选标准

  • 1. Over 50 years of age.
  • 2. Mild to moderate dry eye.
  • 3. Life expectancy of more than 6 months’ (length of study).
  • 4. Ability to return for study visits.

排除标准

  • 1. Current smoker.
  • 2. Known to suffer from an allergy or hypersensitivity to any of the components within the medical device.
  • 3. Taking any other eye drops for dry eye.
  • 4. Taking any other eye drops containing cyclodextrin.
  • 5. Has used contact lenses within the last 4-7 days.
  • 6. Has dry eye secondary to eyelid malposition, corneal dystrophy, ocular neoplasia, filamentous keratitis, corneal neovascularisation or orbital radiotherapy, or a history of ocular disease including traumatism, infection, inflammation, allergy, or herpes within the last 3 months.
  • 7. History of inflammatory corneal ulcer or uveitis within the last 12 months.
  • 8. Has allergic rhinitis that is current or susceptible to reactivation during the study
  • 9. Has had cataract or corneal surgery in the last 12 months.
  • 10. Currently participating in any other clinical trial or has participated in another clinical trial within 3 months prior to the screening/baseline visit.
  • 11. Not physically able to perform study procedures.
  • 12. History of drug/alcohol abuse, mental dysfunction or other factors limiting their ability to cooperate fully.
  • 13. Has any other condition, which in the opinion of the investigator, would make the subject not a suitable candidate for the study.

研究者

发起方
Warneford Healthcare Ltd.

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