A Study of the Safety and Efficacy of Bimatoprost in Patients With Glaucoma or Ocular Hypertension
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Allergan
- 入组人数
- 222
- 主要终点
- Change From Baseline in Mean Peak Macroscopic Conjunctival Hyperemia at Month 1
研究概览
简要总结
A one month study which will determine the safety and efficacy of bimatoprost eye drops in patients with glaucoma or ocular hypertension
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
- Quadruple (Participant, Care Provider, 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
- •Chronic glaucoma or ocular hypertension
- •IOP controlled on Xalatan
排除标准
- •Uncontrolled medical conditions
- •Known hypersensitivity to study medications
研究组 & 干预措施
1
bimatoprost eye drops
干预措施: bimatoprost eye drops (Drug)
2
placebo
干预措施: placebo (Drug)
结局指标
主要结局
Change From Baseline in Mean Peak Macroscopic Conjunctival Hyperemia at Month 1
时间窗: Baseline, Month 1
Change from Baseline in macroscopic conjunctival hyperemia (or visible eye redness). Macroscopic conjunctival hyperemia is graded by the investigator who compares the patient's visual appearance of eye redness to standard photographs using a 5-point scale (Scale 0 to +3: none, trace, mild, moderate, severe). The peak change is calculated for each eye by subtracting the largest score across the hourly measurements at baseline from the largest score across the hourly measurements at month 1. A positive number severity grade change from baseline indicated an increase in redness.
次要结局
- Percentage of Patients With an Increase in Macroscopic Conjunctival Hyperemia in Either Eye at Month 1(Month 1)
- Change From Baseline in Mean Intraocular Pressure (IOP) at Month 1(Baseline, Month 1)
- Percentage of Physicians Who Were Very or Extremely Willing to Continue Patient on Drug, if Drug Were Marketed at Month 1(Month 1)
- Percentage of Patients Who Were Very or Extremely Willing to Use This Glaucoma Medication at Month 1(Month 1)
- Percentage of Patients Who Reported No Change in the Appearance of Their Eyes Since the Beginning of the Study at Month 1(Month 1)