NCT01568593已完成3 期
Comparison of the Efficacy and Safety of T2750 and Vismed® in the Treatment of Moderate to Severe Dry Eye Syndrome
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 93
- 试验地点
- 1
- 主要终点
- Global Ocular Staining (With Oxford Scale - Ranges :0-15)
研究概览
简要总结
Comparison of the efficacy and safety of T2750 and Vismed® in the treatment of moderate to severe Dry Eye Syndrome
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Investigator)
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
- •Signed and dated informed consent
- •Male or female aged from ≥ 18 years old.
- •Known Dry Eye Syndrome requiring artificial tears within the last 3 months prior to study selection.
排除标准
- •Best far corrected visual acuity < 1/10
- •Severe blepharitis
- •Severe Dry Eye
- •Eyelid malposition
- •Known hypersensitivity to one of the components of the study medications or test products.
- •Pregnant or breast-feeding woman.
- •Woman of childbearing age (neither menopausal, nor hysterectomised, nor sterilized) not using effective contraception (oral contraceptives, intra-uterine device, contraceptive implant or condoms).
- •Inability of patient to understand the study procedures and thus inability to give informed consent.
- •Non compliant patient (e.g. not willing to attend the follow-up visits, way of life interfering with compliance).
- •Already included once in this study.
- •Patient under guardianship.
结局指标
主要结局
Global Ocular Staining (With Oxford Scale - Ranges :0-15)
时间窗: Baseline and 35 days
Change from baseline in the worse eye on Day 35 (decrease of Oxford score = better outcome)
次要结局
未报告次要终点
研究者
研究点 (1)
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