A Dose Ranging, Multicenter, Sham-Controlled Study to Evaluate the Safety and Efficacy of Corneal Cross-linking in Subjects With Keratoconus
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 150
- 试验地点
- 3
- 主要终点
- Topography
研究概览
简要总结
Clinical Trial to Evaluate the Safety and Efficacy of Corneal Cross-linking in Subjects with Keratoconus.
详细描述
This is a a dose ranging, multi-center, sham-controlled study to evaluate the safety and efficacy of epithelium-on corneal collagen cross-linking. The study will evaluate safety and efficacy in subjects who have 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
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Provide written informed consent
- •Ability to hold gaze sufficiently stable for study testing
- •Willingness and ability to follow all instructions and comply with schedule for follow-up visits
- •Have a diagnosis of keratoconus
排除标准
- •Known allergy or sensitivity to the test articles or components
- •Any disease causing abnormal topography other than keratoconus
- •Prior or current ocular condition (other than keratoconus) in the study eye that may predispose the eye for future complications
研究组 & 干预措施
Riboflavin Ophthalmic Solution and UV-A Irradiation Group 1 / Cohort 1
Riboflavin Solution + Exposure to NXL system to achieve total energy level 3
干预措施: NXL Energy 3 (Combination Product)
Riboflavin Ophthalmic Solution and UV-A Irradiation Group 3 / Cohort 2A
Riboflavin Solution + Exposure to NXL system to achieve total energy level 1
干预措施: NXL Energy 1 (Combination Product)
Riboflavin Ophthalmic Solution and UV-A Irradiation Group 4 / Cohort 2A
Riboflavin Solution + Exposure to NXL system to achieve total energy level 2
干预措施: NXL Energy 2 (Combination Product)
Riboflavin Ophthalmic Solution and UV-A Irradiation Group 5 / Cohort 2A
Riboflavin Solution + Exposure to NXL system to achieve total energy level 3
干预措施: NXL Energy 3 (Combination Product)
Riboflavin Ophthalmic Solution and UV-A Irradiation Group 3 / Cohort 2B
Riboflavin Solution + Exposure to NXL system to achieve total energy level 1
干预措施: NXL Energy 1 (Combination Product)
Riboflavin Ophthalmic Solution and UV-A Irradiation Group 4 / Cohort 2B
Riboflavin Solution + Exposure to NXL system to achieve total energy level 2
干预措施: NXL Energy 2 (Combination Product)
Riboflavin Ophthalmic Solution and UV-A Irradiation Group 5 / Cohort 2B
Riboflavin Solution + Exposure to NXL system to achieve total energy level 3
干预措施: NXL Energy 3 (Combination Product)
Placebo Group 2 / Cohort 2B
Sham Solution with no exposure to NXL System
干预措施: Sham Treatment (Combination Product)
结局指标
主要结局
Topography
时间窗: 12 Months
Change in Kmax topography value from baseline
次要结局
- Distance Uncorrected Visual Acuity (UCVA)(12 Months)