A Phase III, Prospective, Double-Masked, Randomized, Multi-Center, Active-Controlled, Parallel Group Comparison Study Assessing the Ocular Hypotensive Efficacy of Reformulated PG324 Ophthalmic Solution in Subjects With Elevated Intraocular Pressure
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 489
- 试验地点
- 46
- 主要终点
- Mean Intraocular Pressure at each timepoint post-randomization
研究概览
简要总结
This study is designed to see how safe and effective a new eye drop, called Reformulated PG324, is for lowering eye pressure in people with open-angle glaucoma (OAG) or ocular hypertension (OHT).
详细描述
About 470 adults with OAG or OHT will be randomly divided into 2 groups. One group will use the new Reformulated PG324 eye drops, and the other group will use the marketed PG324 eye drops. This study will be double-masked, so neither the researcher nor the participant will know which eye drop was administered. The expected individual duration of participation is approximately 3 months.
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
- Double (Participant, 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 open-angle glaucoma or ocular hypertension in both eyes;
- •Unmedicated intraocular pressure measurements in the study eye as specified in the protocol;
- •Corrected distance visual acuity equal to or better than 20/100 in the study eye.
排除标准
- •Current use of more than 2 ocular hypotensive medications within 30 days;
- •Intraocular pressure greater than 36 millimeters mercury (mmHg) at Screening;
- •Use of topical ocular medication of any kind within 5 days of Screening or throughout the study with the exception of ocular hypotensive medications (must be washed out).
研究组 & 干预措施
Reformulated PG324
One drop of netarsudil 0.01%/latanoprost 0.005% ophthalmic solution in each eye in the evening for three months
干预措施: Netarsudil 0.01%/latanoprost 0.005% ophthalmic solution (Drug)
PG324
One drop of netarsudil 0.02%/latanoprost 0.005% ophthalmic solution in each eye in the evening for three months
干预措施: Netarsudil 0.02%/latanoprost 0.005% ophthalmic solution (Drug)
结局指标
主要结局
Mean Intraocular Pressure at each timepoint post-randomization
时间窗: Week 2, Week 6, Month 3 at 08:00, 10:00, 16:00 hours
Intraocular pressure (IOP) will be measured with a Goldmann tonometer and recorded in millimeters mercury (mmHg). IOP will be calculated as the mean of two readings or the median of three readings at each timepoint.
次要结局
- Proportion of subjects with moderate to severe conjunctival hyperemia as assessed by biomicroscopy(Up to Month 3/study exit)
- Proportion of subjects with conjunctival hyperemia adverse events(Up to Month 3/study exit)
- Mean change from diurnally adjusted baseline IOP at each timepoint post-randomization(Baseline (Day 1), Week 2, Week 6, Month 3 at 08:00, 10:00, 16:00 hours)
- Percent change from diurnally adjusted baseline IOP at each timepoint post-randomization(Baseline (Day 1), Week 2, Week 6, Month 3 at 08:00, 10:00, 16:00 hours)
- Mean TSS-IOP scores at Month 3(Month 3)
- Mean Changes in TSS-IOP scores from Screening to Month 3(Month 3)
- Percent change from diurnally adjusted baseline IOP at each timepoint post-randomization(Baseline (Day 1), Week 2, Week 6, Month 3 at 08:00, 10:00, 16:00 hours)
- Mean TSS-IOP scores at Month 3(Month 3)
- Proportion of subjects with moderate to severe conjunctival hyperemia as assessed by biomicroscopy(Up to Month 3/study exit)
- Proportion of subjects with conjunctival hyperemia adverse events(Up to Month 3/study exit)
- Mean change from diurnally adjusted baseline IOP at each timepoint post-randomization(Baseline (Day 1), Week 2, Week 6, Month 3 at 08:00, 10:00, 16:00 hours)
- Mean Changes in TSS-IOP scores from Screening to Month 3(Month 3)