Outcomes of Direct Selective Laser Trabeculoplasty With the Post-treatment Addition of Combination Netarsudil and Latanoprost vs Latanoprost Monotherapy
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Change in mean diurnal intraocular pressure (IOP) from baseline
研究概览
简要总结
This is a randomized, double-masked, single-site, prospective, contralateral eye study designed to evaluate the outcomes of Direct Selective Laser Trabeculoplasty (DSLT) followed by the addition of combination netarsudil and latanoprost (Rocklatan) versus latanoprost monotherapy. The study will be conducted at one investigational site. The primary endpoint is the change in mean diurnal intraocular pressure (IOP) from baseline (post DSLT and post washout) at visit 3 between the two groups. Secondary endpoints include the change in mean IOP from baseline at each timepoint (8am, 12pm, 4pm) at visit 3 between groups, and the mean percentage decrease in IOP from baseline for each group. Assessments will be conducted at three key visits: Visit 1 (Screening Phase and DSLT Procedure on Day 0), Visit 2 (Baseline Visit post washout at Week 8), and Visit 3 (Follow-Up Visit 1 at Week 12). Each visit will include specific examinations and measurements such as visual field and OCT imaging, diurnal IOP measurements, and documentation of adverse events.
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
- 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
- •Adults (≥18 years) with a diagnosis of mild to moderate bilateral primary open-angle glaucoma (POAG) or open-angle glaucoma (OAG).
- •On 3 topical glaucoma medications at screening, one of which must be a prostaglandin analog.
- •Post-DSLT and post-washout, baseline intraocular pressure (IOP) 16-36 mmHg in both eyes.
- •Best-corrected visual acuity (BCVA) ≥20/60 in both eyes.
- •Ability and willingness to provide informed consent.
排除标准
- •Ocular hypertension only (no glaucomatous damage).
- •Inability or medical ineligibility for washout of ocular hypotensive medications.
- •Prior selective laser trabeculoplasty (SLT) within 12 months of screening.
- •History of glaucoma surgery (trabeculectomy, tube shunt, minimally invasive glaucoma surgery [MIGS] affecting outflow).
- •Narrow or closed angles with gonioscopy (Shaffer grading ≤2).
- •Active ocular infection, uveitis, or severe dry eye.
- •Corneal pathology interfering with IOP measurement.
- •Advanced glaucoma (threat to fixation).
- •Known hypersensitivity to Rocklatan, latanoprost, or study medication components.
- •Pregnancy or lactation.
研究组 & 干预措施
Rocklatan
netarsudil and latanoprost 0.02%/0.005%
干预措施: Rocklatan 0.02%-0.005% Ophthalmic Solution (Drug)
Lantanoprost
0.005%
干预措施: Latanoprost 0.005% Ophthalmic Solution (Drug)
结局指标
主要结局
Change in mean diurnal intraocular pressure (IOP) from baseline
时间窗: 3 months post-treatment initiation
次要结局
- Change in mean intraocular pressure (IOP) from baseline at each time of day(3 months post-treatment initiation)
- Mean percentage decrease in intraocular pressure (IOP) from baseline(3 months post-treatment initiation)