NCT07838129尚未招募4 期
A Randomized, Double-Masked, Placebo-Controlled, Parallel-Group Evaluation of the Corneal Endothelium Health of Eyes Treated With Articaine Ophthalmic Solution, or Placebo
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 入组人数
- 165
- 主要终点
- Corneal Endothelial Cell Density Change From Baseline to Day 90
研究概览
简要总结
The goal of this clinical trial is to evaluate the corneal endothelium health of eyes treated with articaine ophthalmic solution in adult participants.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Double (Participant, 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
- 是
入选标准
- •Able to voluntarily provide written informed consent to participate in the study.
- •In the Investigator's opinion, generally healthy and free from significant medical or ocular conditions.
排除标准
- •History of ocular surgery (extraocular or intraocular) in either eye within 6 months prior to Screening Visit
- •History of intravitreal injection in either eye within 14 days prior to Visit 2.
研究组 & 干预措施
Articaine ophthalmic solution (CYKLX)
Experimental
The participant will be administered of Articaine ophthalmic solution
干预措施: Articaine (CYKLX) (Drug)
Vehicle
Placebo Comparator
The participant will be administered of vehicle ophthalmic solution (without active substance).
干预措施: Vehicle (Drug)
结局指标
主要结局
Corneal Endothelial Cell Density Change From Baseline to Day 90
时间窗: Baseline and Day 90 post-IP administration
The primary endpoint is the mean change from baseline in the number/density of corneal endothelial cells 90 days post treatment with articaine ophthalmic solution or placebo.
次要结局
未报告次要终点
研究者
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