Evaluation of the Safety and Effectiveness of Tears Naturale® Free and Tears Naturale® II Lubricant Eye Drops in Subjects With Dry Eye Disease
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 120
- 试验地点
- 12
- 主要终点
- Mean Impact of Dry Eye on Everyday Life - Symptom Bother Module (IDEEL - SB) Score
研究概览
简要总结
The purpose of this post-market clinical follow-up (PMCF) study is to describe the effectiveness and safety of Tears Naturale® Free and Tears Naturale® II lubricant eye drops in subjects experiencing dry eye (DE) symptoms.
详细描述
Each subject's participation will last approximately 30 days and include three scheduled visits: a screening/baseline clinic visit on Day 1 (Visit 1), a telephone follow-up visit on Day 15 (-2/+5 days) (Visit 2), and an in-office visit on Day 30 (-2/+5 days) (Visit 3).
This study will be conducted in Canada.
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
- None
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
- •Able to read, understand, and sign an Institutional Review Board (IRB)/Independent Ethics Committee (IEC) approved informed consent form in English or French.
- •Able to attend all study visits as required as per protocol.
- •Mild to moderate dry eye disease.
- •Willing to discontinue use of all habitual artificial tear supplements and use only the study device for the entire study duration.
- •Other protocol-defined inclusion criteria may apply.
排除标准
- •Any known allergic reactions to the study products or its ingredients.
- •Ocular injury to either eye in the past 3 months prior to screening.
- •Ocular surgery within the previous 6 months or ocular surgery planned during the study.
- •Use of any systemic medication known to cause dry eye for less than 1 month before the Screening/Baseline visit.
- •Other protocol-defined exclusion criteria may apply.
研究组 & 干预措施
Tears Naturale Free
One to two drops of artificial tears per eye as needed for 30 days (-2/+5 days)
干预措施: Tears Naturale Free lubricating eye drops (Other)
Tears Naturale II
One to two drops of artificial tears per eye as needed for 30 days (-2/+5 days)
干预措施: Tears Naturale II lubricating eye drops (Other)
结局指标
主要结局
Mean Impact of Dry Eye on Everyday Life - Symptom Bother Module (IDEEL - SB) Score
时间窗: Screening/Baseline Visit (Day 1), Day 30
The IDEEL SB module is a 20-question, patient-reported outcome questionnaire that assesses the subject's symptoms of dry eye. For each question, the subject selected a single response for both eyes, where 0="None of the time" (Q1) or "I did not have this symptom/Not Applicable" (Q2-20) to 4="All of the time" (Q1) or "Very Much" (Q2-20). The overall Symptom Bother score is calculated as the mean value of the non-missing item scores (Q1-20) multiplied by 25, for an overall resultant score ranging from 0 to 100. Higher scores indicate greater symptom bother.
次要结局
未报告次要终点