A Multi-center, Randomized, Double-Masked, Vehicle-Controlled Study Evaluating the Efficacy and Safety of Licaminlimab for the Treatment of Dry Eye Disease
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Oculis
- 入组人数
- 122
- 试验地点
- 1
- 主要终点
- To evaluate the efficacy of licaminlimab in subjects with signs of dry eye disease
研究概览
简要总结
The goal of this clinical trial is to learn about licaminlimab (OCS-02) in the treatment of dry eye disease. The main question it aims to answer is if licaminlimab ophthalmic solution is more effective than vehicle in treating signs of dry eye disease.
详细描述
This is a Phase 2b, multicenter, randomized, double-masked, vehicle-control study designed to evaluate the efficacy and safety of licaminlimab for the treatment of 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.
- •Be willing and able to comply with all study procedures.
- •Have a history of dry eye disease for at least 6 months prior to Visit 1.
排除标准
- •Have any clinically significant slit-lamp findings at least one eye at Visit 1 that may include active blepharitis, meibomian gland dysfunction, 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 in at least one eye at Visit 1 or Visit
- •Have worn contact lenses within 7 days of Visit 1 or anticipate using contact lenses in the study eye during the study.
- •Additional inclusion/exclusion criteria apply.
研究组 & 干预措施
licaminlimab (OCS-02)
60 mg/mL licaminlimab ophthalmic solution
干预措施: licaminlimab (Drug)
licaminlimab (OCS-02)
60 mg/mL licaminlimab ophthalmic solution
干预措施: Artificial tears (Other)
Vehicle
Vehicle of licaminlimab (OCS-02) ophthalmic solution
干预措施: vehicle of OCS-02 (Other)
Vehicle
Vehicle of licaminlimab (OCS-02) ophthalmic solution
干预措施: Artificial tears (Other)
结局指标
主要结局
To evaluate the efficacy of licaminlimab in subjects with signs of dry eye disease
时间窗: Baseline to Day 43
Endpoints of signs of dry eye disease (staining, redness, Schirmer's test) at various time points throughout the study
次要结局
未报告次要终点