NCT06449352已完成4 期
Effect of the Addition of Netarsudil 0.02% vs. Brimonidine 0.1% in Normal Tension Glaucoma Patients Currently on Latanoprost 0.005%
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 4
- 主要终点
- Mean diurnal intraocular pressure
研究概览
简要总结
A randomized, multicenter, investigator-masked prospective study of NTG patients currently on latanoprost 0.005% monotherapy, to study the effect of IOP change with the introduction of netarsudil 0.02% vs brimonidine 0.1%. Subjects will be assessed at a screening visit, and 1 follow-up visit. Clinical evaluations will include visual acuity and IOP .
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 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
- •Patients 18 years and older
- •Diagnosed with normal tension glaucoma based on the following:
- •IOP ≤ 21mmHg
- •Optic nerve rim thinning and/or retinal nerve fiber layer (RNFL) loss consistent with glaucoma
- •Normal visual field OR visual field loss consistent with optic nerve or RNFL defects within the last year
- •Open angles assessed by gonioscopy
- •Have been on latanoprost monotherapy for at least 6 weeks
排除标准
- •If any of the following exclusion criteria are applicable to the subject or either eye, the subject should not be enrolled in the study.
- •Patients with angle closure glaucoma or secondary forms of glaucoma due to neovascularization of the angle, uveitic glaucoma, congenital glaucoma, or glaucoma due to congenital anomalies.
- •Other forms of secondary glaucoma.
- •Patients with abnormal anterior segment examination other than cataract will be excluded from the study.
- •Patients who have had incisional surgery for glaucoma (eg: MIGs).
- •Patients with refractory CME or CME persisting 3 months or more.
- •Children, cognitive impaired and critically ill subjects will not be enrolled.
- •Central Corneal Thickness (CCT) ≤
- •Prior allergy to brimonidine or netarsudil, and known to have previously failed either brimonidine or netarsudil.
- •Ocular surgery (e.g., cataract, laser, refractive) during the study or 1 year prior to entering the study.
- •The principal investigator reserves the right to declare a patient ineligible or non- evaluable based on medical evidence that indicates they are unsuitable for the trial.
研究组 & 干预措施
Netarsudil
Experimental
netarsudil 0.02%
干预措施: Netarsudil (Drug)
Brimonidine
Active Comparator
brimonidine 0.1%
干预措施: Brimonidine (Drug)
结局指标
主要结局
Mean diurnal intraocular pressure
时间窗: After 6 weeks of treatment
Intraocular pressure will be measure at 8am, 12pm, and 4pm
次要结局
- Percentage of diurnal intraocular pressure reduction(After 6 weeks of treatment)
- Mean intraocular pressure at 8am(After 6 weeks of treatment)
- Mean intraocular pressure at 12pm(After 6 weeks of treatment)
- Mean intraocular pressure at 4pm(After 6 weeks of treatment)
研究者
研究点 (4)
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