A Phase 3, Multicenter, Randomized, Double-Masked and Vehicle-Controlled Study Evaluating the Efficacy and Safety of Tanfanercept (HL036) Ophthalmic Solution 0.25% and 1.0% Compared to Vehicle in Participants With Dry Eye Disease (VELOS-4)
试验速览
- 阶段
- 3 期
- 状态
- 暂停
- 入组人数
- 750
- 试验地点
- 1
- 主要终点
- Schirmer Test
研究概览
简要总结
The objectives of this study are to compare the efficacy and safety of tanfanercept ophthalmic solution 0.25% and 1.0% to vehicle for the treatment of DED.
详细描述
The purpose of this research study is to test the safety and effectiveness (how well the drug works) of Tanfanercept ophthalmic solution 0.25% and Tanfanercept ophthalmic solution 1% against vehicle (no active treatment). Effectiveness will be measured by the improvement in Schirmer Test results (a test to see how many tears you produce), reduction of dry eye symptoms, eye redness (conjunctival redness), and eye surface irritation (corneal staining, conjunctival staining). Eye safety assessments will also be performed.
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
- •Are at least 18 years of age
- •Provide written informed consent
- •Are willing to attend all study visits and able to comply with study procedures and assessments
- •Have a self-reported history of DED (OU) for at least 6 months prior to Visit 1
排除标准
- •Have an uncontrolled systemic disease
- •Have been exposed to an investigational drug or device within 30 days or 5 half-lives prior to Visit 1, whichever is longer
研究组 & 干预措施
0.25% tanfanercept
0.25% tanfanercept ou bid for 12 weeks
干预措施: tanfanercept (Drug)
1.0% tanfanercept
1.0% tanfanercept ou bid for 12 weeks
干预措施: tanfanercept (Drug)
Vehicle
Vehicle ou bid for 12 weeks
干预措施: Vehicle (Drug)
结局指标
主要结局
Schirmer Test
时间窗: 12 weeks
The proportion of participants with improvement from baseline in unanesthetized Schirmer
次要结局
- Schirmer Test(2 weeks, 4 weeks, 8 weeks, 12 weeks)
- VAS(2 weeks, 4 weeks, 8 weeks, 12 weeks)
- Conjunctival redness(2 weeks, 4 weeks, 8 weeks, 12 weeks)
- Corneal staining(2 weeks, 4 weeks, 8 weeks, 12 weeks)
- Symptom Assessment in Dry Eye(2 weeks, 4 weeks, 8 weeks, 12 weeks)