Efficacy of Different Treatment Regimens With Chitosan-N- Acetylcysteine (Lacrimera®) in Moderate-to-severe Dry Eye Disease: A Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 48
- 试验地点
- 2
- 主要终点
- Duration of treatment
研究概览
简要总结
Aim of this pilot study is to evaluate the best treatment regime of Chitosan-N-Acetylcysteine (Lacrimera®) compared to preservative-free, Hyaluronic-acid containing eyedrops (Hylo-Vision® sine).
详细描述
The present pilot study seeks to investigate the best fitting treatment regime of moderate-to-severe DED with C-NAC compared to preservative-free, Hyaluronic-acid containing eyedrops (Hylo-Vision® sine) by applying a randomized, prospective, adaptive, controlled design.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Investigator)
盲法说明
The study will be carried out in an observer-masked fashion, therefore the investigator performing the measurements will not be informed about the treatment group that patients are assigned to.
入排标准
- 年龄范围
- 22 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age older than 22 years
- •Corneal staining (marked to severe; NEI grading scale >=10)
排除标准
- •Usage of eye drops other than lubricants (e.g. antibiotics, steroids, cyclosporin-A)
- •Usage of systemic antibiotic therapy
- •Any pathology of the ocular surface except dry eye disease (e.g. corneal scarring, cornea ectasia)
- •Ocular surgery within prior 3 months to screening
- •Preceding refractive corneal surgery (e.g. LASIK)
- •Ocular injury within prior 3 months
- •Ocular herpes of eye or eyelid within prior 3 months
- •Active ocular infection
- •Active ocular inflammation or history of chronic, recurrent ocular inflammation within prior 3 months
- •Eyelid abnormalities that affect lid function
- •Ocular surface abnormality that may compromise corneal integrity
- •Pregnancy and nursing women (in women of childbearing age a pregnancy test will be performed before inclusion into the study)
结局指标
主要结局
Duration of treatment
时间窗: 1 month
Duration of treatment in days until objectively confirmed recovery (NEI (National Eye Institute) grading ≤1 OR OSDI (Ocular Surface Disease Index) score \<20, either 7±1, 14±1, 21±1 or 28±1 days) in the study group compared to the control group.
次要结局
- Change in NI-BUT (Non-invasive Break Up Time)(1 month)
- Change in BUT (Break Up Time)(1 month)
- OSDI (Ocular Surface Disease Index)(1 month)
- Flourescein staining / Lissamin green staining grading using the NEI Score (National Eye Institute)(1 month)
- Change in number of MMP-positive eyes (Matrix Metallopeptidase 9)(1 month)
研究者
Prim. Prof. Dr. Oliver Findl, MBA
Principal Investigator
Vienna Institute for Research in Ocular Surgery