NCT05695781已完成3 期
A Multi-Center, Randomized, Double Masked, Vehicle Controlled Clinical Study to Assess the Safety and Efficacy of BRM421 Ophthalmic Solution in Subjects With Dry Eye Using a Controlled Adverse Environment (CAE®) Model
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 740
- 试验地点
- 1
- 主要终点
- Ocular Sign: Change From Baseline in Total Corneal Fluorescein Staining Score
研究概览
简要总结
The objective of this study is to compare the safety and efficacy of BRM421 OS to vehicle for the treatment of the signs and symptoms of dry eye disease.
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
- •Be at least 18 years of age;
- •Provide written informed consent;
- •Have a reported history of dry eye prior to enrollment;
- •Have a history of use or desire to use eye drops;
排除标准
- •Have any clinically significant slit lamp findings at Visit 1 that may include active blepharitis, meibomian gland dysfunction (MGD), lid margin inflammation or active ocular allergies that require therapeutic treatment, and/or in the opinion of the investigator may interfere with study parameters;
- •Be diagnosed with an ongoing ocular infection (bacterial, viral, or fungal), or active ocular inflammation at Visit 1;
- •Have worn contact lenses within 7 days of Visit 1 or anticipate using contact lenses during the study;
- •Have used any eye drops within 2 hours of Visit 1;
- •Have previously had laser-assisted in situ keratomileusis (LASIK) surgery within the last 12 months;
- •Be a woman of childbearing potential who is not using an acceptable means of birth control;
研究组 & 干预措施
BRM421 Ophthalmic Solution
Active Comparator
干预措施: BRM421 Ophthalmic Solution (Drug)
Vehicle
Placebo Comparator
干预措施: Vehicle (Drug)
结局指标
主要结局
Ocular Sign: Change From Baseline in Total Corneal Fluorescein Staining Score
时间窗: 1-2 weeks
0-12 Ora scale, higher scores mean a worse outcome.
Ocular Symptom: Change From Baseline in Visual Analog Scale (VAS)
时间窗: 1-2 weeks
0-100 Visual Analog Scale, higher scores mean a worse discomfort.
次要结局
未报告次要终点
研究者
研究点 (1)
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