NCT01895972已完成3 期
A Single-Arm, Multicenter, Open-Label Study Evaluating the Long-Term Safety of Latanoprostene Bunod Ophthalmic Solution 0.024%, in Japanese Subjects With Open-Angle Glaucoma or Ocular Hypertension
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 130
- 试验地点
- 1
- 主要终点
- Change From Baseline in Intraocular Pressure
研究概览
简要总结
The objective of this study is to demonstrate the clinical safety of latanoprostene bunod 0.024% once daily (QD) over a 1-year treatment period.
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
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects must have a diagnosis of open angle glaucoma (OAG) (including normal-tension glaucoma [NTG],pigmentary or pseudoexfoliative glaucoma), or ocular hypertension (OHT) in one or both eyes.
- •Subjects must meet the following IOP requirements at Visit 3 (Eligibility, Day 0[after washout for the subjects already on treatment]): mean/median IOP ≥15 mmHg and ≤36 mmHg at 10 AM in at least 1 eye; and IOP ≤36 mmHg in both eyes.
- •Subjects with a corrected Decimal visual acuity (VA) or a Best-Corrected Decimal Visual Acuity (BCVA) of 0.5 or better in both eyes.
排除标准
- •Subjects who are unable to discontinue contact lens use during and for 15 minutes following instillation of study drug and during study visits.
- •Subjects who are unable to discontinue other eye drop medications such as artificial tears for 15 minutes prior to and 15 minutes after instillation of study drug.
- •Subjects with a central corneal thickness greater than 600 μm in either eye.
- •Subjects with any condition that prevents reliable applanation tonometry in either eye.
- •Subjects with advanced glaucoma with a mean deviation (MD) < -12 dB, a history of split fixation, or a field loss threatening fixation in either eye.
- •Subjects with any condition that prevents clear visualization of the fundus.
- •Subjects who are monocular (fellow eye is absent).
- •Subjects with aphakia in either eye.
- •Subjects with an active corneal disease in either eye.
- •Subjects with severe dry eye in either eye.
- •Subjects with a history/diagnosis of a clinically significant or progressive retinal disease in either eye.
- •Subjects with very narrow angles and subjects with angle closure congenital, or secondary glaucoma, and subjects with history of angle closure in either eye.
- •Subjects with any intraocular infection or inflammation in either eye within 3 months prior to Visit 1 (Screening).
- •Subjects with a history of ocular laser surgery in either eye within the 3 months (90 days) prior to Visit 1 (Screening).
- •Subjects with a history of incisional ocular surgery or severe trauma in either eye within 3 months prior to Visit 1 (Screening).
研究组 & 干预措施
Latanoprostene Bunod
Experimental
Latanoprostene bunod 0.024% instilled into the eye once daily (QD) over a 1-year treatment period.
干预措施: Latanoprostene bunod (Drug)
结局指标
主要结局
Change From Baseline in Intraocular Pressure
时间窗: Baseline and week 4,8,12,16,20,24,28,32,36,40,44,48,52
Change from baseline in intraocular pressure (IOP) following treatment with latanoprostene bunod 0.024% (instilled QD in the evening) with IOP assessed every 4 weeks from Week 4 to Week 52.
Clinical Safety
时间窗: 1 year
Ocular adverse events reported over one year of once daily dosing of latanoprostene bunod 0.024%. Below is the percentage of subjects with \>/=1 ocular AE Specifics of AEs are captured in the AE section.
次要结局
未报告次要终点
研究者
研究点 (1)
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