Phase 2, Single-Center, Randomized, Double-Masked, Placebo-Controlled Clinical Study to Assess the Safety and Efficacy of SkQ1 Ophth Sol'n in the Environment and During Challenge in the Controlled Adverse Environment (CAE) Model for the Treatment of DES
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Mitotech, SA
- 入组人数
- 91
- 试验地点
- 1
- 主要终点
- Inferior Corneal Fluorescein Staining
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
Single-center, double-masked, randomized, placebo-controlled study comprising 4 visits over the course of approximately 5 weeks. The study included a 1-week placebo (SkQ1 vehicle) run-in period between Visit 1 and Visit 2, and approximately 28 days of twice daily (BID) dosing (Visit 2 - Visit 4). Qualified subjects were randomized 1:1:1 to receive either 1.55 µg/mL SkQ1 ophthalmic solution, 0.155 µg/mL SkQ1 ophthalmic solution, or placebo (vehicle of SkQ1 ophthalmic solution).
The following primary endpoints were tested:
- Corneal Fluorescein staining in the inferior region Pre-CAE at Visit 4 (Day 29), as measured by the Ora Calibra Scale in the worst eye at baseline;
- Worst dry eye symptom (ocular discomfort, dryness, or grittiness - as determined from subject diary data recorded during the 1-week run-in period between Visit 1 and Visit 2) evaluated over the seven days preceding Visit 4 (not including day of visit) during the treatment period.
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
- Triple (Participant, 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 male or female of any race, at least 18 years of age
- •Have provided written informed consent
- •Have a reported history of dry eye syndrome
- •Have a history of use or desire to use eye drops for dry eye
排除标准
- •Have any clinically significant eye findings that require therapeutic treatment or may interfere with study parameters
- •Have previously had LASIK surgery within the last 12 months
- •Have used Restasis® within 30 days of Visit 1
- •Be a woman who is pregnant, nursing or planning a pregnancy
- •Be unwilling to submit a urine pregnancy test if of childbearing potential
- •Have a known allergy and/or sensitivity to the test article or its components, including the preservative benzalkonium chloride
- •Be currently enrolled in an investigational drug or device study or have used an investigational drug or device within 30 days of Visit 1
- •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
研究组 & 干预措施
Low Dose SkQ1
Drug: Low Dose 0.155µg/mL SkQ1 ophthalmic solution administered twice daily for 28 days
干预措施: Low Dose 0.155µg/mL SkQ1 ophthalmic solution (Drug)
High Dose SkQ1
Drug: High Dose 1.55µg/mL SkQ1 ophthalmic solution administered twice daily for 28 days
干预措施: High Dose 1.55µg/mL SkQ1 ophthalmic solution (Drug)
Placebo (vehicle)
Drug: Placebo (vehicle) ophthalmic solution administered twice daily for 28 days
干预措施: Placebo (Vehicle) opthalmic solution (Drug)
结局指标
主要结局
Inferior Corneal Fluorescein Staining
时间窗: Day 29
The dry eye sign primary efficacy variable of corneal fluorescein staining of the inferior region of the eye measured on a 0-4 point scale where 0 = no staining and 4 = most staining between treatment arms at day 29
Worst Symptom Based on Diary Data
时间窗: Day 29
Worst dry eye symptom (as determined from subject diary data recorded during the 1-week run-in period) evaluated over the seven days preceding Day 29 during the treatment period. The scale was on a 0-5 range where 0= no symptoms and 5= worst symptoms measured for a number of dry eye symptoms.
次要结局
未报告次要终点