Prospective, Randomized, Double- Masked Study to Evaluate the Effect of Rhopressa Versus Placebo on Intraocular Pressure (IOP) in Patients With Primary Open-Angle Glaucoma or Ocular Hypertension Post-Selective Laser Trabeculoplasty (SLT)
试验速览
- 阶段
- 4 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 70
- 试验地点
- 2
- 主要终点
- Mean diurnal intraocular pressure (IOP)
研究概览
简要总结
The purpose of this study is to collect data about how Rhopressa affects IOP in patients who have had an SLT procedure in both eyes.
详细描述
This is a prospective, randomized, double-masked, placebo controlled (artificial tears), single center study. The study population will include seventy (n=70) subjects with POAG or ocular hypertension who have undergone SLT and may benefit from additional IOP reduction. If individuals are a candidate for treatment with Rhopressa (netarsudil) 0.02% ophthalmic solution post-SLT, they can potentially be included in the trial. The study duration per subject is expected to be 6 weeks (or up to 12 weeks if washout is required for previous IOP lowering treatment) with three scheduled study visits.
While both Rhopressa and 360 degrees SLT primarily target the trabecular meshwork, potential synergistic effects of the two therapies on conventional aqueous outflow are not completely understood. This study will determine whether initiation of Rhopressa post-360 degrees SLT provides greater IOP reduction than 360 degrees SLT alone. This information will aid healthcare providers in selecting the best approach to management of IOP in patients who have recently undergone 360 degrees SLT and may benefit from additional IOP reduction.
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 (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
- •Age ≥ 18 years
- •Documented diagnosis of bilateral POAG or ocular hypertension as determined by the investigator based on medical record review.
- •At Screening (V1), the subject completed SLT in both the eyes within the last 90 days.
- •Mean diurnal IOP of 16 to 28 mmHg at Randomization (V2 )
- •At Randomization (V2), in the opinion of the investigator, subject may benefit from additional IOP reduction in the study eye and is a candidate for treatment with Rhopressa
- •At Randomization (V2), if treated with IOP-lowering medication(s) in either eye prior to SLT, subject has completed the minimum washout period for the medication(s) (see Table 1)
- •If female, subject is either incapable of pregnancy (e.g., history of bilateral oophorectomy, hysterectomy, bilateral tubal ligation) or post-menopausal (amenorrheic for at least 2 years) or will use an effective (e.g., double barrier) method of birth control for the duration of the study
排除标准
- •History of more than one treatment with SLT in either eye
- •Unable or unwilling to discontinue current IOP-lowering medication(s), if applicable
- •Prior or current treatment with a rho kinase inhibitor
- •Prior microinvasive glaucoma surgery (MIGS)
- •Advanced stage of glaucoma, as determined by the investigator based on medical record review
- •Any condition that prevents reliable applanation tonometry in either eye (e.g., significant corneal surface abnormalities, scars, keratoconus)
- •Previous or currently active corneal disease that, in the opinion of the investigator, could affect the study outcomes
- •Active or recurrent intraocular infection, inflammation, iritis or uveitis
- •Retinal disease (e.g., diabetic retinopathy, macular degeneration, central retinal vein or artery occlusion, macular edema)
- •Intraocular injection performed ≤ 6 months prior to Screening (V1)
- •Anticipated use of any topical ocular steroids and/or topical ocular nonsteroidal anti-inflammatory drugs (NSAID) during the study period
- •Current participation in any drug or device clinical investigation, receipt of investigational drug within 6 drug half-lives of Screening (V1), or any previous placement of an investigational device.
- •Any condition in the opinion of the investigator that would potentially confound the results of this study
研究组 & 干预措施
Rhopressa
干预措施: Netarsudil ophthalmic solution 0.02% (Drug)
Artificial Tears
干预措施: Artificial tears (Drug)
结局指标
主要结局
Mean diurnal intraocular pressure (IOP)
时间窗: 42 Days
Between-group difference in change in mean diurnal IOP
次要结局
未报告次要终点