An Evaluation of the 24-Hour Intraocular Pressure(IOP)-Lowering Effect of Bimatoprost Sustained-Release(SR) in Participants With Open-Angle Glaucoma(OAG) or Ocular Hypertension(OHT)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 37
- 试验地点
- 6
- 主要终点
- Change From Baseline in Time-Matched Intraocular Pressure (IOP) for Bimatoprost SR Treated Eyes
研究概览
简要总结
This study will evaluate the 24-hour intraocular pressure lowering effect and safety after a single administration of Bimatoprost SR in patients with Open-Angle Glaucoma or Ocular Hypertension
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 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
- •Diagnosis of either OAG or OHT study eye, requiring IOP-lowering treatment
- •Participant is currently a nonsmoker and has not smoked any nicotine-containing products within the previous 6 months
排除标准
- •Current or anticipated enrollment in another investigational drug or device study
- •Females who are pregnant, nursing, or planning a pregnancy during the study
研究组 & 干预措施
Bimatoprost SR 10 μg
Participants will receive Bimatoprost SR 10 μg implant in the study eye on Day 1 and standard of care treatment in the fellow eye for the duration of the study.
干预措施: Bimatoprost SR (Drug)
LUMIGAN 0.01%
Participants will receive topical LUMIGAN 0.01% in the study eye once daily starting evening Dose on Day 1 and standard of care treatment in the fellow eye for the duration of the study.
干预措施: LUMIGAN (Drug)
结局指标
主要结局
Change From Baseline in Time-Matched Intraocular Pressure (IOP) for Bimatoprost SR Treated Eyes
时间窗: 8 weeks
IOP is a measurement of the fluid pressure inside the study eye. A negative change from baseline indicates an improvement and a positive change from baseline indicates a worsening.
Number of Patients Experiencing One or More Treatment Emergent Adverse Events (TEAEs)
时间窗: Up to 12 Months
The number of patients who experienced one or more TEAEs
次要结局
- Change From Baseline in Range of Intraocular Pressure (IOP) for Bimatoprost SR-treated Eyes(8 Weeks)