Comparison of the Performance and Safety of T2769 Versus Hylo-Forte® in the Treatment of Moderate to Severe Dry Eye Syndrome.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 74
- 试验地点
- 6
- 主要终点
- To Demonstrate the Non-inferiority of T2769 Compared to Hylo-Forte® in Terms of Total Ocular Surface Staining (Oxford Score).
研究概览
简要总结
The objective is to demonstrate the non-inferiority of T2769 compared to Hylo-Forte® in terms of the change from baseline (D1) in total ocular surface staining score assessed on Oxford 0-15 scale, in the study eye at the D36 visit.
The investigation is defined as a post-market stage. The clinical investigation design is confirmatory.
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
- •Main Inclusion Criteria (At Screening visit):
- •Informed consent signed and dated (obtained prior to initiating any procedures).
- •Patient aged ≥18 years old.
- •Persistence of dry eye syndrome, despite artificial tears use in the previous month prior to the screening visit
排除标准
- •(At both Screening and Randomisation visits):
- •Far Best-Corrected Visual Acuity (BCVA) ≥+0.7 LogMar (e.g., ≤0.2 in decimal value or ≤20/100 Snellen equivalent or ≤50 letters Early Treatment Diabetic Retinopathy Study (ETDRS)).
- •Patient with previous or current ophthalmic condition
研究组 & 干预措施
T2769
Hyaluronic acid, Trehalose, Naaga
Route of administration: topical, ocular use
干预措施: T2769 (Device)
Hylo-Forte®
Hyaluronic acid
Route of administration: topical, ocular use
干预措施: Hylo-Forte® (Device)
结局指标
主要结局
To Demonstrate the Non-inferiority of T2769 Compared to Hylo-Forte® in Terms of Total Ocular Surface Staining (Oxford Score).
时间窗: Oxford 0-15 grading scheme: is assessed at Day 1, Day 15 and Day 36
The primary endpoint is the change from baseline (Day 1) in total ocular surface staining grade according to Oxford Scale 0-15 grading scheme at D36 in the study eye. Minimum value is 0 (better case) and maximum value is 15 (worse case)
次要结局
未报告次要终点