Prospective Randomized Study to Determine Whether Use of Rhopressa™ Can Ameliorate Corneal Edema Associated With Fuchs Dystrophy
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 29
- 试验地点
- 1
- 主要终点
- Change in Central Corneal Thickness
研究概览
简要总结
The study objective is to determine whether use of Rhopressa improves the ability of corneal endothelial cells to maintain appropriate corneal hydration in patients with Fuchs endothelial corneal dystrophy (FECD), which could help delay or prevent the need for a corneal transplant.
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
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
The active drug and placebo will be provided in 2.5 ml bottles identical, in appearance. Only the designated dosing coordinator is unmasked.
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
- •At least 18 years of age
- •Male or female patient diagnosed with FECD and corneal edema evident by slit lamp exam and/or corneal tomography.
- •Patient is able and willing to administer eye drops.
- •Patient is able to comprehend and has signed the Informed Consent form.
排除标准
- •Active intraocular inflammation, corneal ulceration, keratitis, or conjunctivitis.
- •Known sensitivity to any of the ingredients in the study medications.
- •Abnormal eyelid function.
- •History of herpetic keratitis.
- •History of non-compliance with using prescribed medication.
- •Current or planned pregnancy within the study duration.
- •Concurrent involvement or participation in another randomized clinical trial within 30 days prior to enrollment in this study.
- •Any ocular or systemic condition (i.e., UNCONTROLLED systemic disease) or situation which in the investigator's opinion may put the patient at significant risk, confound the study results, or interfere significantly with the patient's participation in the study.
研究组 & 干预措施
Netarsudil
A drop of Netarsudil 0.02% ophthalmic solution will be instilled into both eyes once daily at night.
干预措施: Netarsudil Ophthalmic Solution (Drug)
Placebo
A placebo eye drop, consisting of the vehicle for netarsudil ophthalmic solution without the active ingredient, will be instilled into both eyes once daily at night.
干预措施: Placebo (Drug)
结局指标
主要结局
Change in Central Corneal Thickness
时间窗: 1 month
Central corneal thickness at 1 month after randomization minus central corneal thickness at baseline
次要结局
- Change in Corrected Distance Visual Acuity (CDVA)(3 months)