A Phase 1/2a Assessment of WB007 Ophthalmic Solution in Subjects With Primary Open-Angle Glaucoma or Ocular Hypertension
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 77
- 试验地点
- 1
- 主要终点
- Part 2: Mean Change From Baseline in Intraocular Pressure (IOP) at Day 14 - Study Eye
研究概览
简要总结
The study evaluated the safety and IOP-lowering effects of WB007 in adults with primary open-angle glaucoma or ocular hypertension in both eyes. This was a 2-part study. Part 1 was a 3-period dose escalation that evaluated 3 concentrations of WB007 ophthalmic solution following a single dose in one eye. Part 2 was a randomized, double-masked, parallel comparison that evaluated two concentrations of WB007 (selected based on Part 1 results) in both eyes compared with timolol 0.5% for 14 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
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
Part 1 - not masked; Part 2 - Double-masked - neither investigator, study staff nor study participant were aware of treatment assignment
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
- •Ocular hypertension or primary open-angle glaucoma in each eye
排除标准
- •History of orthostatic hypotension
- •Any active ocular disease
- •Anticipated wearing of contact lenses during study
- •Contraindication to pupil dilatation
研究组 & 干预措施
Part 2: WB007 0.4%
WB007 0.4%, dosed twice daily for 14 days
干预措施: WB007 0.4% (Drug)
Part 1 (Period 1): WB007 0.05%
WB007 0.05%, single dose to study eye on Day 1
干预措施: WB007 0.05% (Drug)
Part 1 (Period 2): WB007 0.15%
WB007 0.15%, single dose to study eye on Day 1
干预措施: WB007 0.15% (Drug)
Part 1 (Period 3): WB007 0.4%
WB007 0.4%, single dose to study eye on Day 1
干预措施: WB007 0.4% (Drug)
Part 2: WB007 0.15%
WB007 0.15%, dosed twice daily for 14 days
干预措施: WB007 0.15% (Drug)
Part 2: Timolol 0.5%
Timolol 0.5%, dosed twice daily for 14 days.
干预措施: Timolol 0.5% (Drug)
结局指标
主要结局
Part 2: Mean Change From Baseline in Intraocular Pressure (IOP) at Day 14 - Study Eye
时间窗: Baseline, Day 14
IOP is a measurement of the pressure inside the eye and was measured using Goldmann applanation tonometry. Study participants used the study medications in both eyes for 14 days. One eye was designated as the Study Eye at baseline: eyes that met inclusion and exclusion criteria. If both eyes were eligible, the study eye was the eye with higher IOP at Baseline at Hour 0. If both eyes had the same IOP at this timepoint, the right eye was designated as the study eye. IOP was measured at Baseline and Day 14 at Hours 0, 2, 4 and 8. The primary endpoint was the mean change from baseline IOP at Day 14, Hour 2, the timepoint of the peak effect of timolol.
次要结局
- Part 2: Mean IOP at Day 14 - Study Eye(Baseline, Day 14)