Efficacy and Safety Assessment of T1695 Ophthalmic Suspension, Versus Ciclosporin Ophthalmic Emulsion, in Participants With Moderate to Severe Vernal Keratoconjunctivitis (VKC)
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 120
- 试验地点
- 11
- 主要终点
- Change from baseline (Day 1) at Day 29 (Week 4) in Corneal Fluorescein Staining (CFS) grade assessed by the (0-5) modified Oxford scale in the study eye.
研究概览
简要总结
The aim of the study is to Compare the Effectiveness and Safety of T1695 Versus Ciclosporin in Participants with Moderate to Severe Vernal Keratoconjunctivitis
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
- 4 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Main Inclusion Criteria:
- •Informed consent signed and dated
- •Male or female participant from 4 years to less than 18 years old.
- •Participant with grading score of 3 or 4 on the Bonini scale for clinical grading of VKC in each eye.
排除标准
- •Participants must not have any conditions which might exclude them from participating, could interfere with the study, or pose an unacceptable risk to their health.
研究组 & 干预措施
T1695
The participant should instill T1695.
干预措施: Slit Lamp Examination (Diagnostic Test)
Ciclosporin
The participant should instill Ciclosporin.
干预措施: Ciclosporin (Drug)
T1695
The participant should instill T1695.
干预措施: Far Best Corrected Visual Acuity (BCVA) (Diagnostic Test)
T1695
The participant should instill T1695.
干预措施: T1695 (Drug)
T1695
The participant should instill T1695.
干预措施: Corneal fluorescein staining score on modified Oxford scale (Diagnostic Test)
Ciclosporin
The participant should instill Ciclosporin.
干预措施: Slit Lamp Examination (Diagnostic Test)
Ciclosporin
The participant should instill Ciclosporin.
干预措施: Far Best Corrected Visual Acuity (BCVA) (Diagnostic Test)
Ciclosporin
The participant should instill Ciclosporin.
干预措施: Corneal fluorescein staining score on modified Oxford scale (Diagnostic Test)
结局指标
主要结局
Change from baseline (Day 1) at Day 29 (Week 4) in Corneal Fluorescein Staining (CFS) grade assessed by the (0-5) modified Oxford scale in the study eye.
时间窗: From Day 1 to Day 29
次要结局
未报告次要终点