A Phase 3, Multi-Center, Randomized, Double-Masked, Placebo-Controlled Study of Safety and Efficacy of SkQ1 Ophthalmic Solution in the Environment and the Controlled Adverse Environmental (CAE®) Model for the Treatment of Dry Eye Syndrome
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Mitotech, SA
- 入组人数
- 610
- 试验地点
- 4
- 主要终点
- Ocular Discomfort Scale
研究概览
简要总结
The purpose of this study is to evaluate whether SkQ1 Ophthalmic Solution is safe and effective compared to Vehicle for the treatment of the signs and symptoms of dry eye syndrome.
详细描述
Multi-center, double-masked, randomized, placebo-controlled study comprising 5 visits over the course of approximately 9 weeks. Qualified subjects are randomized 1:1 to receive either SkQ1 Ophthalmic Solution, or Placebo (vehicle of SkQ1 Ophthalmic Solution).
The Primary Endpoints are:
Change from Baseline (Visit 2) to Visit 5 of Ocular Discomfort;
Change from Baseline (Visit 2) to Visit 5 of conjunctival fluorescein staining (sum of temporal and nasal regions)
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
- •Be at least 18 years of age;
- •Provide written informed consent;
- •Have a subject reported history of dry eye;
- •Have a history of use of eye drops for dry eye symptoms;
- •Ocular Discomfort;
- •Schirmer's Test score;
- •Have corneal fluorescein staining ;
- •Have lissamine green conjunctival Staining;
- •Have a conjunctival redness;
排除标准
- •Have been previously exposed to previous SkQ1 Ophthalmic Solution treatment;
- •Have any clinically significant slit lamp findings at Visit 1;
- •Be diagnosed with an ongoing ocular infection or active ocular inflammation at Visit 1;
- •Have had any ocular and/or lid surgeries within 6 months of Visit 1 or any planned over the study period;
- •Have an uncontrolled systemic disease;
- •Be a woman who is pregnant, nursing or planning a pregnancy;
- •Be a woman of childbearing potential who is not using an acceptable means of birth control;
- •Have a known allergy and/or sensitivity to the study drug or its components;
- •Have a condition or be in a situation which the investigator feels may put the subject at significant risk, may confound the study results, or may interfere significantly with the subject's participation in the study;
- •Be currently enrolled in an investigational drug or device study or have used an investigational drug or device within 30 days of Visit 1;
研究组 & 干预措施
Placebo Comparator: SkQ1 Vehicle
Vehicle for SkQ1 Ophthalmic Solution
干预措施: SkQ1 Vehicle Solution (Drug)
SkQ1
SkQ1 Ophthalmic Solution
干预措施: SkQ1 Ophthalmic Solution (Drug)
结局指标
主要结局
Ocular Discomfort Scale
时间窗: From baseline to Day 57
Change of Ocular Discomfort Scale, scale ranged from 0 to 4 with 0 = No Discomfort and 4 = Constant Discomfort.
Conjunctival Fluorescein Staining
时间窗: From baseline to Day 57
Change of Conjunctival Fluorescein Staining (sum of temporal and nasal regions), scale in each region ranged from 0 to 4 with 0 = No Staining and 4 = Confluent Staining
次要结局
未报告次要终点