NCT06100952已完成3 期
A Multicenter, Randomized, Double-Masked, Sham-Controlled, Parallel-Group Phase 3 Study to Evaluate the Efficacy and Safety of Epithelium-On Corneal Cross-linking in Subjects 8 to 45 Years of Age With Keratoconus (APRICITY-B)
Epion Therapeutics24 个研究点 分布在 1 个国家目标入组 398 人开始时间: 2023年11月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 398
- 试验地点
- 24
- 主要终点
- Best Spectacle-Corrected Distance Visual Acuity (BSCDVA)
研究概览
简要总结
A Multicenter, Randomized, Double-Masked, Sham-Controlled, Parallel-Group Phase 3 Study to Evaluate the Efficacy and Safety of Epithelium-On Corneal Cross-linking in Subjects 8 to 45 Years of Age With Keratoconus
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 8 Years 至 45 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of keratoconus
排除标准
- •Minimal corneal thickness < 350 microns
- •Non-keratoconic ectatic disease
- •Contraindications or hypersensitivities to any required study medications
- •Pregnancy or breastfeeding
- •Certain concomitant ocular conditions
研究组 & 干预措施
Active Treatment
Experimental
Epithelium-on corneal cross-linking
干预措施: Riboflavin and Sodium Iodide solution and Ultraviolet-A treatment (Combination Product)
Control Treatment
Placebo Comparator
Placebo and sham for epithelium-on corneal cross-linking
干预措施: Placebo and sham treatment (Combination Product)
结局指标
主要结局
Best Spectacle-Corrected Distance Visual Acuity (BSCDVA)
时间窗: Baseline to 12 months
BSCDVA will be assessed using Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity testing charts. The score ranges from 0 to 100, with a higher score representing better visual functioning.
次要结局
- Vision-related Quality of Life as Assessed by the National Eye Institute 25-Item Visual Function Questionnaire (NEI-VFQ-25)(Baseline to 12 months)
研究者
研究点 (24)
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