An Open-label (Stage 1) and Randomized (Stage 2), 24 Month Study of Safety and Efficacy of Bimatoprost Drug Delivery System in Patients With Open-Angle Glaucoma or Ocular Hypertension
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Allergan
- 入组人数
- 109
- 试验地点
- 57
- 主要终点
- Change From Baseline in Time-Matched Intraocular Pressure (IOP) in the Study Eye
研究概览
简要总结
This study will evaluate the safety and efficacy of new ophthalmic formulations of bimatoprost in patients with open angle glaucoma and ocular hypertension. At least 3 dose strengths will be evaluated based on internal data review of each cohort. The study was planned to be conducted in 2 stages. Stage 1 was an open-label and Stage 2 was planned to be masked; however only Stage 1 was conducted.
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
- 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
- •Diagnosis of open angle glaucoma or ocular hypertension
排除标准
- •Uncontrolled medical conditions
- •Anticipated wearing of contact lenses during the study
研究组 & 干预措施
bimatoprost 20 µg generation 2, bimatoprost 0.03%
Single dose of bimatoprost ophthalmic 20 µg generation 2 administered in the study eye on Day 1. One drop bimatoprost ophthalmic solution 0.03% (LUMIGAN®) administered in the non-study eye once daily every evening for up to 24 months.
干预措施: bimatoprost 20 µg generation 2 (Drug)
bimatoprost 20 µg generation 2, bimatoprost 0.03%
Single dose of bimatoprost ophthalmic 20 µg generation 2 administered in the study eye on Day 1. One drop bimatoprost ophthalmic solution 0.03% (LUMIGAN®) administered in the non-study eye once daily every evening for up to 24 months.
干预措施: bimatoprost 0.03% (Drug)
bimatoprost 15 µg generation 2, bimatoprost 0.03%
Single dose of bimatoprost ophthalmic 15 µg generation 2 administered in the study eye on Day 1, and once between 90 days and 12 months after the first dose (if applicable). One drop bimatoprost ophthalmic solution 0.03% (LUMIGAN®) administered in the non-study eye once daily every evening for up to 24 months.
干预措施: bimatoprost 15 µg generation 2 (Drug)
bimatoprost 15 µg generation 2, bimatoprost 0.03%
Single dose of bimatoprost ophthalmic 15 µg generation 2 administered in the study eye on Day 1, and once between 90 days and 12 months after the first dose (if applicable). One drop bimatoprost ophthalmic solution 0.03% (LUMIGAN®) administered in the non-study eye once daily every evening for up to 24 months.
干预措施: bimatoprost 0.03% (Drug)
bimatoprost 10 µg generation 2, bimatoprost 0.03%
Single dose of bimatoprost ophthalmic 10 µg generation 2 administered in the study eye on Day 1, and once between 90 days and 12 months after the first dose (if applicable). One drop bimatoprost ophthalmic solution 0.03% (LUMIGAN®) administered in the non-study eye once daily every evening for up to 24 months.
干预措施: bimatoprost 10 µg generation 2 (Drug)
bimatoprost 10 µg generation 2, bimatoprost 0.03%
Single dose of bimatoprost ophthalmic 10 µg generation 2 administered in the study eye on Day 1, and once between 90 days and 12 months after the first dose (if applicable). One drop bimatoprost ophthalmic solution 0.03% (LUMIGAN®) administered in the non-study eye once daily every evening for up to 24 months.
干预措施: bimatoprost 0.03% (Drug)
bimatoprost 6 µg generation 2, bimatoprost 0.03%
Single dose of bimatoprost ophthalmic 6 µg generation 2 administered in the study eye on Day 1, and once between 90 days and 12 months after the first dose (if applicable). One drop bimatoprost ophthalmic solution 0.03% (LUMIGAN®) administered in the non-study eye once daily every evening for up to 24 months.
干预措施: bimatoprost 6 µg generation 2 (Drug)
bimatoprost 6 µg generation 2, bimatoprost 0.03%
Single dose of bimatoprost ophthalmic 6 µg generation 2 administered in the study eye on Day 1, and once between 90 days and 12 months after the first dose (if applicable). One drop bimatoprost ophthalmic solution 0.03% (LUMIGAN®) administered in the non-study eye once daily every evening for up to 24 months.
干预措施: bimatoprost 0.03% (Drug)
bimatoprost 15 µg generation 1, bimatoprost 0.03%
Single dose of bimatoprost ophthalmic 15 µg generation 1 administered in the study eye on Day 1. One drop bimatoprost ophthalmic solution 0.03% (LUMIGAN®) administered in the non-study eye once daily every evening for up to 24 months.
干预措施: bimatoprost 15 µg generation 1 (Drug)
bimatoprost 15 µg generation 1, bimatoprost 0.03%
Single dose of bimatoprost ophthalmic 15 µg generation 1 administered in the study eye on Day 1. One drop bimatoprost ophthalmic solution 0.03% (LUMIGAN®) administered in the non-study eye once daily every evening for up to 24 months.
干预措施: bimatoprost 0.03% (Drug)
bimatoprost 10 µg generation 1, bimatoprost 0.03%
Single dose of bimatoprost ophthalmic 10 µg generation 1 administered in the study eye on Day 1. One drop bimatoprost ophthalmic solution 0.03% (LUMIGAN®) administered in the non-study eye once daily every evening for up to 24 months.
干预措施: bimatoprost 10 µg generation 1 (Drug)
bimatoprost 10 µg generation 1, bimatoprost 0.03%
Single dose of bimatoprost ophthalmic 10 µg generation 1 administered in the study eye on Day 1. One drop bimatoprost ophthalmic solution 0.03% (LUMIGAN®) administered in the non-study eye once daily every evening for up to 24 months.
干预措施: bimatoprost 0.03% (Drug)
结局指标
主要结局
Change From Baseline in Time-Matched Intraocular Pressure (IOP) in the Study Eye
时间窗: Baseline, Month 24
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.
次要结局
- Time-Matched Intraocular Pressure (IOP) in the Study Eye(Baseline to Month 6)
- Mean Diurnal IOP in the Study Eye(Baseline, Month 6)
- Time to Rescue Treatment or Re-Treatment in the Study Eye(24 Months)