A Phase 3, Multi-Center, Randomized, Double-Masked, Placebo-Controlled Clinical Study to Assess the Safety and Efficacy of SkQ1 Ophthalmic Solution 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
- 452
- 试验地点
- 7
- 主要终点
- Central Corneal Staining Change From Baseline
研究概览
简要总结
The purpose of this study is to evaluate whether SkQ1 ophthalmic solutions are safe and effective compared to placebo 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 1:1:1 to receive either High Dose SkQ1 ophthalmic solution, Low Dose SkQ1 ophthalmic solution, or Placebo (vehicle of SkQ1 ophthalmic solution).
The Primary Endpoints are:
Change from Baseline (Visit 2) to Visit 5 in Corneal Fluorescein Staining;
Change from Baseline (Visit 2) to Visit 5 in Grittiness Symptom
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 participated in the previous SkQ1 ophthalmic solution Phase 2 treatment study;
- •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
SkQ1 Vehicle
SkQ1 (Vehicle)
干预措施: SkQ1 (Vehicle) (Drug)
Low Dose - SkQ1
Low-dose ophthalmic solution
干预措施: Low Dose - SkQ1 (Drug)
High Dose - SkQ1
High-dose ophthalmic solution
干预措施: High dose - SkQ1 (Drug)
结局指标
主要结局
Central Corneal Staining Change From Baseline
时间窗: From baseline to Day 57
Change of Corneal Fluorescein Staining from baseline to Day 57, scale ranges from 0 to 4, where grade 0 = None, 4 = Severe
Grittiness Change From Baseline
时间窗: From baseline to Day 57
Change of patient-reported grittiness from baseline to Day 57, scale ranges from 0 to 5 for each symptom, where 0 = None and 5 = Worst
次要结局
未报告次要终点