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.
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