Topical Cadaveric-Derived Corneal Epithelial Stem Cell Transplant Therapy for the Treatment of Severe Dry Eye Disease
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 17
- 试验地点
- 2
- 主要终点
- Ocular Surface Disease Index (OSDI)
研究概览
简要总结
To study of a novel, therapeutic Human Cells, Tissues, and Cellular and Tissue-Based Product (HCT/P) in the treatment of severe dry eye disease that is failing conventional treatments. This pilot study will carefully observe and monitor each qualifying and willing individual for response to treatment, signs of toxicity and adverse effects from the treatment, and for ability of the treatment to improve comfort and restore vision.
详细描述
Eligible patients presenting with severe dry eye disease that have failed treatment with conventional measures will be screened for inclusion into the study. The treatment will consist of administration of formulated topical eye drops containing cadaveric epithelial stem cell-derived product. These eye drops will be transplanted by topical self-administration by the patient four times daily in both eyes for a three month interval.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical diagnosis of advanced dry eye disease
- •Severe dry eye symptoms despite having tried over a half dozen treatments
排除标准
- •Not willing to undergo clinical trial
- •Unable to comply with treatment regimen
结局指标
主要结局
Ocular Surface Disease Index (OSDI)
时间窗: 3 months
Patient Reported Outcome by Survey
次要结局
- Visual Acuity(3 months)
- Corneal Topography(3 months)
研究者
Sloan W. Rush, MD
Physician
Panhandle Eye Group, LLP