NCT03248037已完成3 期
Randomized, Double-masked, Placebo-controlled Evaluation of Netarsudil for Prevention of Corticosteroid-induced Intraocular Pressure Elevation
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Intraocular Pressure
研究概览
简要总结
Cornea transplant recipients who are using topical corticosteroids long-term to prevent transplant rejection will be randomized to use netarsudil or placebo.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
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 undergoing Descemet membrane endothelial keratoplasty; patient is able and willing to administer eye drops; patient is able to comprehend and has signed the Informed Consent form; patient is likely to complete the nine-month course of the study.
排除标准
- •A patient exhibiting pre-operative intraocular inflammation; a patient with a known sensitivity to any of the ingredients in the study medications; a patient who has a condition (i.e., UNCONTROLLED systemic disease) or is in a situation which in the investigator's opinion may put the patient at significant risk, may confound the study results, or may interfere significantly with the patient's participation in the study; a patient with abnormal eyelid function; a patient that is exhibiting active corneal ulceration, keratitis, or conjunctivitis, or who has a history of herpetic keratitis; a patient who has been diagnosed with uncontrolled glaucoma, prior aqueous shunt or trabeculectomy, or with preoperative intraocular pressure > 22 mm Hg in the potential study eye; presence of any ocular disease that would interfere with the evaluation of the study treatment (however, patients with a history of cystoid macular edema, age-related macular degeneration, corneal neovascularization, and other non-interfering comorbidities may be enrolled); a patient with a history of non-compliance with using prescribed medication; a patient who is concurrently involved in or participated in another randomized clinical trial within 30 days prior to enrollment in this study; patients who are pregnant or planning to become pregnant within the duration of the study.
研究组 & 干预措施
Netarsudil
Experimental
Netarsudil ophthalmic solution 0.02%, dosed topically once a day for 9 months
干预措施: Netarsudil (Drug)
Placebo
Placebo Comparator
Placebo eye drop, dosed topically once a day for 9 months
干预措施: Placebo (Drug)
结局指标
主要结局
Intraocular Pressure
时间窗: from date of randomization until the date of first documented intraocular pressure elevation exceeding defined threshold up to 9 months
Intraocular pressure measurement exceeding 24 mm Hg or more than 10 mm Hg greater than the pre-randomization reading.
次要结局
未报告次要终点
研究者
研究点 (1)
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