A Phase II, Prospective, Two-Stage, Double-Masked, Randomized, Multi-Center, Controlled, Dose-Response Study Assessing the Safety and Ocular Hypotensive Efficacy of AR-17043 and PG043 (AR-17043/Latanoprost) Ophthalmic Solutions in Subjects With Elevated Intraocular Pressure
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 426
- 试验地点
- 12
- 主要终点
- Mean diurnal IOP at Day 29 (Stage 2)
研究概览
简要总结
The purpose of this two-stage clinical trial is to assess the safety and hypotensive efficacy of AR-17043 and PG043 ophthalmic solutions in subjects with open-angle glaucoma (OAG) or ocular hypertension (OHT).
详细描述
During Stage 1, approximately 100 adult subjects with OAG or OHT will be randomized to 5 arms: 3 different concentrations of AR-17043, placebo comparator, or netarsudil 0.02% (Rhopressa®) for a treatment duration of 7 days.
During Stage 2, approximately 350 adult subjects with OAG or OHT will be randomized to 5 arms: low and high concentrations of PG043 (AR-17043/latanoprost 0.005%), AR-17043 high concentration, latanoprost, or netarsudil 0.02%/latanoprost 0.005% (Rocklatan®) for a treatment duration of 28 days.
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
- •Diagnosis of OAG or OHT in both eyes.
- •High unmedicated IOP measurements in the study eye as specified in the protocol.
- •Corrected visual acuity equal to or better than +0.7 logMAR (Snellen equivalent equal to or better than 20/100) in the study eye.
- •Other protocol-specified inclusion criteria may apply.
- •Stage 1 and Stage 2 Key
排除标准
- •Current use of more than 2 ocular hypotensive medications within 30 days (either eye).
- •Intraocular pressure greater than 36 millimeters mercury (mmHg) at Screening.
- •Glaucoma other than OAG.
- •Previous glaucoma surgery.
- •Any abnormality preventing reliable measurements.
- •Unable to demonstrate proper eyedrop instillation.
- •Other protocol-specified exclusion criteria may apply.
研究组 & 干预措施
PG043 high concentration (Stage 2)
PG043 Ophthalmic Solution, one drop in each eye in the evening on Days 1-28.
干预措施: PG043 Ophthalmic Solution (Drug)
AR-17043 low concentration (Stage 1)
AR-17043 Ophthalmic Solution, one drop in each eye in the morning on Day 1, followed by one drop in each eye in the evening on Days 2-7.
干预措施: AR-17043 Ophthalmic Solution (Drug)
AR-17043 medium concentration (Stage 1)
AR-17043 Ophthalmic Solution, one drop in each eye in the morning on Day 1, followed by one drop in each eye in the evening on Days 2-7.
干预措施: AR-17043 Ophthalmic Solution (Drug)
AR-17043 high concentration (Stage 1)
AR-17043 Ophthalmic Solution, one drop in each eye in the morning on Day 1, followed by one drop in each eye in the evening on Days 2-7.
干预措施: AR-17043 Ophthalmic Solution (Drug)
AR-17043 vehicle (Stage 1)
AR-17043 Vehicle, one drop in each eye in the morning on Day 1, followed by one drop in each eye in the evening on Days 2-7.
干预措施: AR-17043 Vehicle (Drug)
Rhopressa (Stage 1)
Netarsudil 0.02% Ophthalmic Solution, one drop in each eye in the morning on Day 1, followed by one drop in each eye in the evening on Days 2-7.
干预措施: Netarsudil 0.02% Ophthalmic Solution (Drug)
PG043 low concentration (Stage 2)
PG043 Ophthalmic Solution, one drop in each eye in the evening on Days 1-28.
干预措施: PG043 Ophthalmic Solution (Drug)
AR-17043 high concentration (Stage 2)
AR-17043 Ophthalmic Solution, one drop in each eye in the evening on Days 1-28.
干预措施: AR-17043 Ophthalmic Solution (Drug)
Latanoprost (Stage 2)
Latanoprost 0.005% Ophthalmic Solution, one drop in each eye in the evening on Days 1-28.
干预措施: Latanoprost 0.005% Ophthalmic Solution (Drug)
Rocklatan (Stage 2)
Netarsudil 0.02%/Latanoprost 0.005% Ophthalmic Solution, one drop in each eye in the evening on Days 1-28.
干预措施: Netarsudil 0.02%/Latanoprost 0.005% Ophthalmic Solution (Drug)
结局指标
主要结局
Mean diurnal IOP at Day 29 (Stage 2)
时间窗: Day 29 (8:00, 10:00, 16:00)
Intraocular pressure (IOP) will be measured with a Goldmann tonometer. Diurnal IOP will be calculated as the average of the three measurements.
Mean diurnal IOP at Day 8 (Stage 1)
时间窗: Day 8 (8:00, 10:00, 12:00, 16:00)
Intraocular pressure (IOP) will be measured with a Goldmann tonometer. Diurnal IOP will be calculated as the average of the four measurements.
次要结局
- Mean change from the diurnally adjusted baseline IOP at each post-treatment timepoint (Stage 1)(Baseline (8:00, 10:00, 12:00, 16:00), Day 1 (8:00, 10:00, 12:00), Day 8 (8:00, 10:00, 12:00, 16:00))
- Mean percent change from baseline mean diurnal IOP at each post-treatment timepoint (Stage 1)(Baseline (8:00, 10:00, 12:00, 16:00); Day 1 (8:00, 10:00, 12:00), Day 8 (8:00, 10:00, 12:00, 16:00))
- Mean percent change from diurnally adjusted baseline IOP at each post-treatment timepoint (Stage 2)(Baseline (8:00, 10:00, 16:00); Day 8 (8:00, 10:00, 16:00); Day 15 (8:00, 10:00, 16:00); Day 29 (8:00, 10:00, 16:00))
- Mean change from baseline mean diurnal IOP at each post-treatment timepoint (Stage 2)(Baseline (8:00, 10:00, 16:00); Day 8 (8:00, 10:00, 16:00); Day 15 (8:00, 10:00, 16:00); Day 29 (8:00, 10:00, 16:00))
- Mean percent change from baseline mean diurnal IOP at each post-treatment timepoint (Stage 2)(Baseline (8:00, 10:00, 16:00); Day 8 (8:00, 10:00, 16:00); Day 15 (8:00, 10:00, 16:00); Day 29 (8:00, 10:00, 16:00))
- Mean IOP at each post-treatment timepoint (Stage 1)(Day 1 (8:00, 10:00, 12:00), Day 8 (8:00, 10:00, 12:00, 16:00))
- Mean change from baseline mean diurnal IOP at each post-treatment timepoint (Stage 1)(Baseline (8:00, 10:00, 12:00, 16:00), Day 1 (8:00, 10:00, 12:00), Day 8 (8:00, 10:00, 12:00, 16:00))
- Mean IOP at each post-treatment timepoint (Stage 2)(Day 8 (8:00, 10:00, 16:00); Day 15 (8:00, 10:00, 16:00); Day 29 (8:00, 10:00, 16:00))
- Mean change from the diurnally adjusted baseline IOP at each post-treatment timepoint (Stage 2)(Baseline (8:00, 10:00, 16:00); Day 8 (8:00, 10:00, 16:00); Day 15 (8:00, 10:00, 16:00); Day 29 (8:00, 10:00, 16:00))
- Mean percent change from diurnally adjusted baseline IOP at each post-treatment timepoint (Stage 1)(Baseline (8:00, 10:00, 12:00, 16:00), Day 1 (8:00, 10:00, 12:00), Day 8 (8:00, 10:00, 12:00, 16:00))