NCT07078955尚未招募2 期
A Phase 2, Multicenter, Randomized, Open-Labeled, Artificial Tear-Controlled, 6-Week Clinical Study to Assess the Dose Regimen, Safety and Efficacy of BRM421 Ophthalmic Solution in Patients With Dry Eye Disease
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 99
- 试验地点
- 1
- 主要终点
- Change from baseline in total corneal fluorescein staining (tCFS) score
研究概览
简要总结
To evaluate the safety and efficacy of BRM421 Ophthalmic Solution compared to artificial tear for treatment of the signs and symptoms of dry eye disease (DED)
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
- None (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
- •Are ≥18 years of age;
- •Are willing and able to comply with all study procedures and restrictions and the visit schedule;
- •Have a self-reported history of dry eye prior to enrollment;
- •If a woman of childbearing potential (WOCBP): are non-lactating, have a negative urine pregnancy test (UPT), and agree to use an acceptable form of contraception for the duration of the study;
排除标准
- •Within 3 months prior to Visit 1, have participated in any other investigational study or used an investigational product or device;
- •Have any history of organ or bone marrow transplant, immunodeficiency disorder, human immunodeficiency virus, or hepatitis C, or any evidence of acute active hepatitis A (anti-hepatitis A virus immunoglobulin M);
- •Have any significant illness or condition that, in the opinion of the Investigator, could affect the study outcome measures. Such illnesses include (but are not limited to) Sjögren's syndrome, rheumatoid arthritis, systemic lupus erythematosus, severe cardiopulmonary disease, poorly controlled hypertension or diabetes, or drug/alcohol addiction;
- •Within 12 months prior to Visit 1, have undergone any ocular surgical procedure, including laser-assisted in situ keratomileusis (LASIK) or a similar corneal refractive surgery;
研究组 & 干预措施
Artificial Tear
Other
干预措施: Artificial Tear (Drug)
BRM421 Ophthalmic Solution, 0.03%
Active Comparator
干预措施: BRM421 Ophthalmic Solution, 0.03% (Drug)
BRM421 Ophthalmic Solution, 0.06%
Active Comparator
干预措施: BRM421 Ophthalmic Solution, 0.06% (Drug)
结局指标
主要结局
Change from baseline in total corneal fluorescein staining (tCFS) score
时间窗: 6 weeks
Total corneal fluorescein staining (tCFS) score by using NEI Scale (0-20, higher scores mean a worse outcome)
次要结局
未报告次要终点
研究者
研究点 (1)
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