NCT07168902已完成2 期
A Phase 2 Evaluation of the Safety, Ocular Tolerability, and Efficacy of Topical Ophthalmic BL1107 Versus Timolol in Adults With Primary Open Angle Glaucoma or Ocular Hypertension
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 252
- 试验地点
- 22
- 主要终点
- Change from baseline in visual field mean deviation in the study eye at Day 28/Exit.
研究概览
简要总结
Phase 2 Study of BL1107 Eye Drops vs. Timolol in Adults with Primary Open Angle Glaucoma or Ocular Hypertension
详细描述
This study will evaluate the safety and efficacy of BL1107 in adults with primary open-angle glaucoma or ocular hypertension in both eyes. This is a randomized, double-masked, parallel comparison to evaluate two concentrations of BL1107 in both eyes compared with timolol 0.5% for 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
- 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
- •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 dilation
研究组 & 干预措施
BL1107 Low dose
Experimental
干预措施: BL1107 Low dose (Drug)
BL1107 High dose
Experimental
干预措施: BL1107 High dose (Drug)
Timolol maleate 0.5%
Active Comparator
干预措施: Timolol maleate 0.5% (Drug)
结局指标
主要结局
Change from baseline in visual field mean deviation in the study eye at Day 28/Exit.
时间窗: Assessed at Day 28
次要结局
- Proportion of participants achieving ≥15-letter improvement in low-luminance best-corrected visual acuity (LL-BCVA) in the study eye at Day 28/Exit.(Assessed at Day 28)
- Proportion of participants achieving ≥10-letter improvement in low-luminance best-corrected visual acuity (LL-BCVA) in the study eye at Day 28/Exit.(Assessed at Day 28)
- Hour-matched change from Baseline in intraocular pressure (IOP) in the study eye at Day 28/Exit.(Assessed at Day 28)
研究者
研究点 (22)
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