NCT07548632招募中2 期
A Phase 2b/3, Double-masked, Randomized, Vehicle-controlled, Multicenter Study Evaluating Licaminlimab in Dry Eye Disease Patients With a Specific TNFR1 Genotype
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- Oculis
- 入组人数
- 160
- 试验地点
- 16
- 主要终点
- Change from baseline in global ocular discomfort severity score at Day 29 in participants with DED and specific TNFR1 genotype
研究概览
简要总结
The primary objective of this study is to evaluate the efficacy and safety of the topical ophthalmic administration of licaminlimab as compared to vehicle in participants with Dry Eye Disease and a specific genotype.
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)
盲法说明
Sponsor
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
- •Physician diagnosis of Dry Eye Disease in the past 6 months
- •Use of over-the-counter tears
- •Must agree to genotype testing
排除标准
- •- Have a history or presence of any disorder or condition that may, in the opinion of the Investigator, likely interfere with the interpretation of the study results or participant safety.
研究组 & 干预措施
Vehicle
Placebo Comparator
Vehicle of licaminlimab ophthalmic solution
干预措施: Vehicle of licaminlimab (Other)
Vehicle
Placebo Comparator
Vehicle of licaminlimab ophthalmic solution
干预措施: Artificial Tear Run-in (Other)
licaminlimab
Experimental
60 mg/mL licaminlimab ophthalmic solution
干预措施: Artificial Tear Run-in (Other)
licaminlimab
Experimental
60 mg/mL licaminlimab ophthalmic solution
干预措施: licaminlimab (Drug)
结局指标
主要结局
Change from baseline in global ocular discomfort severity score at Day 29 in participants with DED and specific TNFR1 genotype
时间窗: From Day 1 to Day 29
次要结局
- Change from baseline in global ocular discomfort severity score at Day 29 in all participants with DED (independent of genotype).(Day 1 to Day 29)
研究者
研究点 (16)
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