A Multi-center, Randomized, Double-masked, Controlled Clinical Trial to Evaluate the Corneal Endothelial Health of Dry Eye Disease Subjects Treated With Cyclosporine Ophthalmic Solution, 0.1%
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Novaliq GmbH
- 入组人数
- 204
- 试验地点
- 7
- 主要终点
- Change from baseline in corneal ECD
研究概览
简要总结
The objective of this trial is to evaluate the effect of cyclosporine ophthalmic solution, 0.1% on corneal endothelial cell health in comparison to a hypotonic saline solution in subjects with Dry Eye Disease (DED)
详细描述
The effect of cyclosporine ophthalmic solution, 0.1% on corneal endothelial cell density (cells/mm²) will be evaluated in comparison to a hypotonic saline solution in subjects with DED after 12 months of treatment.
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, 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
- •Be at least 18 years of age;
- •Provide written informed consent;
- •Have a subject reported history of dry eye disease (DED) in both eyes
- •Be able and willing to follow instructions, including participation in all trial assessments and visits.
排除标准
- •Be a woman who is pregnant, nursing, or planning a pregnancy;
- •Unwillingness to to use acceptable means of birth control
- •Clinically significant slit-lamp findings or abnormal lid anatomy at screening
- •Ongoing ocular or systemic infection at screening or baseline
- •Presence of uncontrolled systemic diseases
- •Presence of known allergy and/or sensitivity to the study drug or its components
- •Intraocular surgery or ocular laser surgery or significant trauma within 365 days before Visit 1, or have any planned ocular surgeries during the trial period
- •Have a condition or be in a situation which the Investigator feels may put the subject at significant risk, may confound the trial results, or may interfere with the subject's participation in the trial significantly.
- •Randomized in a previous CyclASol trial
研究组 & 干预措施
Saline solution, 0.6%
Saline solution, 0.6%; 12 months
干预措施: Saline solution, 0.6% (Drug)
Cyclosporine ophthalmic solution, 0.1% (VEVYE)
Cyclosporine ophthalmic solution, 0.1%; 12 months
干预措施: Cyclosporine ophthalmic solution, 0.1% (Drug)
结局指标
主要结局
Change from baseline in corneal ECD
时间窗: 12 months
ECD measured as count/mm2 using specular microscopy
Change From Baseline in Corneal Endothelial Cell Density (ECD)
时间窗: 12 months
Change from baseline at 12 months in ECD measured as count/mm2 using specular microscopy in the study eye
次要结局
未报告次要终点