Rocklatan Adds Pressure Reduction After MIGS (Minimally Invasive Glaucoma Surgery)
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 68
- 试验地点
- 1
- 主要终点
- Mean diurnal intraocular pressure change from baseline
研究概览
简要总结
The primary objective of this study is to determine if the addition of Rocklatan post-Hydrus will provide additional intraocular pressure lowering.
详细描述
The study is a prospective single-practice with multiple locations, single-surgeon, parallel double arm study in subjects with open angle glaucoma (OAG), who were implanted with Hydrus microstent combined with cataract surgery to be randomized to receive Rocklatan vs. Comparator (artificial tears). Unmedicated MDIOP (mean diurnal intraocular pressure) measurements will be assessed at baseline (after Hydrus, prior to study medication) and at 1-month post-initiation of Study Drop.
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, Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 40 years and older
- •Subjects who have mild to moderate Open Angle Glaucoma (OAG)
- •Subjects who have undergone uncomplicated cataract surgery and Hydrus microstent implantation > 3 months prior to screening and within the last 2 years
- •Post-Hydrus subjects on 0-2 ocular hypotensive medication classes who can safely washout (if on ocular hypotensive medications)
- •Unmedicated or washed out IOP range between 16-26 mmHg
排除标准
- •History of intraocular surgery except for uneventful refractive surgery or uncomplicated cataract surgery and hydrus microstent implantation
- •Prior Selective Laser Trabeculoplasty (SLT) within 18 months of surgery
- •Secondary glaucoma excluding pseudoexfoliation and pigmentary dispersion syndrome
- •Severe Open Angle Glaucoma
- •Narrow angles, other angle abnormalities or angle closure glaucoma
- •Allergy or intolerance to Rocklatan
- •History of corneal edema, or corneal disease or dystrophy
- •Current or history of intra-ocular infection or inflammation
- •History of retinal diseases that could affect diagnostic testing
- •Anticipated use of intra-ocular or topical steroids not associated with the study protocol
- •Pregnant, breastfeeding or planning to become pregnant during the study
- •Any condition in the opinion in the investigator that would potentially confound the results of the study
研究组 & 干预措施
Placebo Comparator Systane Artificial Tears
Comparator arm is Systane artificial tears
干预措施: Systane (Drug)
FDA Approved Rocklatan (netarsudil 0.02% and latanoprost 0.005%)
FDA approved Rocklatan (netarsudil 0.02% and latanoprost 0.005%) is a fixed dose combination of a Rho kinase inhibitor and a prostaglandin analogue indicated for the reduction of elevated intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension.
干预措施: Rocklatan (netarsudil 0.02% and latanoprost 0.005%) (Drug)
结局指标
主要结局
Mean diurnal intraocular pressure change from baseline
时间窗: After 28 days up to 35 days post initiation of Rocklatan vs placebo comparator
After Hydrus prior to study initiation drop
次要结局
- Diurnal Intraocular pressure change from baseline and difference between intraocular pressure at each time point(After Hydrus prior to study drop and after 28 days up to 35 days post initiation of study drop for all time points 8am, 10am, 4pm (± 1 hour) between groups)