NCT06573606已完成不适用
Ophthalmic Solution in Diabetic Corneal Alteration
D&V FARMA srl1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2021年9月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- TBUT
研究概览
简要总结
Data analyses and revision of the DED symptoms in diabetic subjects. A novel ophthalmic solution containing cross-linked ha (CX-HA) and Chondroitin sulphate (CS) has been made available on the market.
Both molecules have been widely studied for their viscoelastic and hydrating properties.
Nevertheless, the use of CS in ophthalmology has been limited since, routinely, the molecule is of animal origins.
This new ophthalmic solution is the first on the market formulated with a CS of non-animal origin.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diabetic Subjects affected by dry eye disease
排除标准
- •know allergies to CX-HA
- •know allergies to CS
结局指标
主要结局
TBUT
时间窗: 3 months
Tear Breakup Time
次要结局
- OSDI(3 months)
- Corneal Sensitivity(3 months)
- Wound Healing(30 hours)
研究者
研究点 (1)
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