A Phase 2, 28 Day Parallel-Group, Double-Masked, Dose-Finding Study Comparing the Safety and Efficacy of PF-03187207 to Latanoprost
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 176
- 试验地点
- 1
- 主要终点
- Change From Baseline Mean Diurnal Intraocular Pressure (IOP) in the Study Eye on Day 28
研究概览
简要总结
This study will evaluate the safety and efficacy of PF 03187207.
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, Care Provider, Investigator)
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 primary open angle glaucoma (including pigmentary or pseudoexfoliative) or ocular hypertension in one or both eyes
排除标准
- •Closed or barely open anterior chamber angle or a history of acute angle closure in either eye
研究组 & 干预措施
PF-03187207 and Latanoprost Vehicle
One drop of each, once daily in study eye for 28 days
干预措施: PF-03187207 and Latanoprost Vehicle (Drug)
Latanoprost 0.005% and PF-03187207 Vehicle
One drop of each, once daily in study eye for 28 days
干预措施: Latanoprost 0.005% and PF-03187207 Vehicle (Drug)
结局指标
主要结局
Change From Baseline Mean Diurnal Intraocular Pressure (IOP) in the Study Eye on Day 28
时间窗: Baseline, 28 days
Intraocular pressure (IOP) was measured using a Goldmann applanation tonometer. Diurnal IOP, defined as the mean IOP over the day based on values obtained at 8 AM, 10 AM, 1 PM, and 4 PM, was calculated for each visit. Both eyes were tested, with the right eye preceding the left eye. The operator initially set the dial at 10 mmHg, then looked through the slit lamp and adjusted the dial to take the reading, and then recorded the results. The procedure was repeated on the same eye twice consecutively. If the measurements were within 2 mmHg or less of each other, the mean of the 2 readings was recorded as the IOP at that time point. If the 2 readings were more than 2 mmHg of each other, a third (consecutive) reading was taken and the median (middle) IOP was recorded as the IOP at that time point.
次要结局
- Change From Baseline in Mean Intraocular Pressure IOP at the Day 7, 14, and 21 Visits(Baseline, Day 7, Day 14, and Day 21)
- Percentage of Participants With Intraocular Pressure (IOP) Less Than or Equal to 18 mmHg at Any Visit Through Day 28(28 days)