NCT05965778已完成不适用
Comparison of the Performance and Safety of T2769 Versus Vismed® Multi in the Treatment of Moderate to Severe Dry Eye Syndrome
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 251
- 试验地点
- 1
- 主要终点
- Surface Ocular Staining With Fluorescein (With Oxford Scale - Ranges : Minimum 0- Maximum 15)
研究概览
简要总结
To demonstrate the non-inferiority of T2769 compared to Vismed® Multi in terms of total ocular surface staining (Oxford score) after 35 days of treatment.
To evaluate the performance and safety of T2769 versus Vismed® Multi.
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
- •Informed consent signed and dated (obtained prior to initiating any procedures).
- •Patient aged ≥18 years old.
- •Known dry eye syndrome requiring artificial tears for at least the last 3 months prior to screening visit.
- •Surface Disease Index (OSDI) Score ≥
- •Ocular discomfort evaluated by VAS ≥ 40 mm.
排除标准
- •Far best-corrected visual acuity (BCVA) ≥+0.7 LogMar (e.g., ≤0.2 in decimal value or ≤20/100 Snellen equivalent or ≤50 (ETDRS) letters Early Treatment Diabetic Retinopathy Study).
- •Severe blepharitis according to the judgment of the investigator
- •Dry eye associated with at least one of the following diseases/symptoms: ocular rosacea, Pterygium, Eyelid malposition, Corneal dystrophy, Ocular neoplasia, Filamentous keratitis, Corneal neovascularisation, Orbital radiotherapy, Cataract, Retinal disease.
研究组 & 干预措施
T2769
Experimental
1 drop in each eye, 3 to 6 times daily
干预措施: T2769 (Device)
Vismed® Multi
Active Comparator
1 drop in each eye, 3 to 6 times daily
干预措施: Vismed® Multi (Device)
结局指标
主要结局
Surface Ocular Staining With Fluorescein (With Oxford Scale - Ranges : Minimum 0- Maximum 15)
时间窗: Oxford 0-15 grading scheme: is assessed at Day 1 and Day 36
Change from baseline (Day 1) in the worse eye at Day 36 in Global Ocular staining (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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