A Phase 2, 28-Day Parallel-Group, Double-Masked, Dose Finding Study Comparing The Safety And Efficacy Of PF-03187207 To Latanoprost In Patients With Primary Open Angle Glaucoma Or Ocular Hypertension.
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 117
- 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
To investigate dose response, safety and efficacy of PF-03187207 in patients with primary open-angle 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
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Man or woman at least 20 years of age
- •Diagnosis of primary open-angle glaucoma or ocular hypertension in one or both eyes.
排除标准
- •Closed/barely open anterior chamber angle or a history of acute angle closure in either eye
- •Contraindications to latanoprost and nitric oxide treatment
- •Known latanoprost non-responders
研究组 & 干预措施
PF-03187207 High Dose and Latanoprost Vehicle
A single drop of each, once daily in study eye for 28 days
干预措施: PF-03187207 (Drug)
PF-03187207 High Dose and Latanoprost Vehicle
A single drop of each, once daily in study eye for 28 days
干预措施: Latanoprost Vehicle (Drug)
Latanoprost 0.005% and PF-03187207 Vehicle
A single drop of each, once daily in study eye for 28 days
干预措施: Latanoprost 0.005% (Drug)
Latanoprost 0.005% and PF-03187207 Vehicle
A single drop of each, once daily in study eye for 28 days
干预措施: PF-03187207 Vehicle (Drug)
PF-03187207 Medium Dose and Latanoprost Vehicle
A single drop of each, once daily in study eye for 28 days
干预措施: PF-03187207 (Drug)
PF-03187207 Medium Dose and Latanoprost Vehicle
A single drop of each, once daily in study eye for 28 days
干预措施: Latanoprost Vehicle (Drug)
PF-03187207 Low Dose and Latanoprost Vehicle
A single drop of each, once daily in study eye for 28 days
干预措施: PF-03187207 (Drug)
PF-03187207 Low Dose and Latanoprost Vehicle
A single drop of each, once daily in study eye for 28 days
干预措施: Latanoprost 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 Specific Time Points on Day 14 and Day 28(Baseline, Day 14, Day 28)
- Target IOP(Up to 28 days)