A Multicenter, Open-Label Rocklatan® (Netarsudil/Latanoprost Ophthalmic Solution) 0.02%/0.005% Evaluation of IOP Lowering Efficacy and Safety as Replacement of Current Medical Therapy Regimen for the Reduction of Elevated Intraocular Pressure in Patients With Glaucoma or Ocular Hypertension
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 136
- 试验地点
- 21
- 主要终点
- Mean Percent Change From Baseline in Intraocular Pressure (IOP) at Week 12
研究概览
简要总结
The objective of this study is to evaluate the IOP-lowering effect when subjects are switched from various latanoprost-based regimens to Rocklatan. Subjects will stop their IOP-lowering medical therapy regimen and dose with Rocklatan for the duration of the study (12 weeks).
详细描述
Enrollment will be stratified according to subject's IOP-lowering medical therapy regimen as follows:
- Latanoprost monotherapy (Latanoprost Mono)
- Latanoprost plus 1 additional IOP-lowering agent (Latanoprost +1)
- Latanoprost plus 2 additional IOP-lowering agents (Latanoprost +2)
Aerie Pharmaceuticals was acquired by Alcon Research LLC on November 22, 2022.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Male or female subjects age 18 or older
- •Current diagnosis of open-angle glaucoma or ocular hypertension
- •Subject currently being treated with latanoprost alone or latanoprost plus 1 or 2 additional agents/bottles. Current IOP lowering regimen is stable for at least 30 days prior to Baseline Visit
- •Treated IOP ≥ 20 mmHg measured in the morning (before noon) at the Baseline Visit by Goldmann applanation tonometer
- •Best corrected Snellen visual acuity of 20/100 or better in both eyes
- •Willingness to follow protocol requirements, including signed informed consent and health information release forms, routine follow-up schedule, completing questionnaires
排除标准
- •Have any active ocular disease other than open-angle glaucoma or ocular hypertension that would interfere with study interpretation
- •Use of fixed dose combination agents as part of the patient's Baseline IOP lowering therapy regimen, if not also on latanoprost
- •Active ocular infection/inflammation or history of uveitis
- •Aphakic or pseudophakic patients with a torn posterior lens capsule, or with known risk factors for macular edema
- •Any systemic disease or clinical evidence of any condition which would make the subject, in the opinion of the investigator, unsuitable for the study or could potentially confound the study results
- •Use of topical, periorbital, intravitreal or systemic steroid within previous 3 months or expected use during the course of the study
- •Prior participation in any investigational drug or device study within the last 30 days prior to the Baseline Visit.
- •Known sensitivity or allergy to the study medication or components
- •Females who are pregnant, nursing, or planning a pregnancy during the study
- •Positive pregnancy test at Baseline Visit (women of childbearing potential only)
- •Women of childbearing potential who are not using a medically acceptable form of birth control
研究组 & 干预措施
Rocklatan
Netarsudil 0.02%/latanoprost 0.005% fixed dose combination ophthalmic solution, one drop in each eye in the evening for 12 weeks
干预措施: Netarsudil 0.02%/latanoprost 0.005% fixed dose combination ophthalmic solution (Drug)
结局指标
主要结局
Mean Percent Change From Baseline in Intraocular Pressure (IOP) at Week 12
时间窗: Baseline (Day 0 pretreatment), Week 12
IOP was measured using Goldmann applanation tonometry at the Baseline and Week 12 visits. One eye (study eye) contributed data to this analysis. A negative value indicates an improvement in IOP. No hypothesis testing was prespecified for this endpoint.
次要结局
未报告次要终点