NCT03183089已完成4 期
A Randomized, Single-Center, Comparative Study of Rohto Dry-Aid® and Systane® Ultra in the Management of Tear Film Stability and Visual Function in Patients With Dry Eye
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Dry Eye Staining
研究概览
简要总结
The objective of this study is to evaluate the efficacy of Rohto Dry-Aid® in comparison to Systane® Ultra on visual function and tear film stability in patients diagnosed with Dry Eye.
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
- Single (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
- •Have a reported history of dry eye
- •Have a history of use of eye drops for dry eye symptoms
- •Ocular discomfort
- •Conjunctival redness
- •Tear film break up time
- •Corneal and Conjunctival Staining
排除标准
- •Have any clinically significant slit lamp findings at entry visit
- •Be diagnosed with an ongoing ocular infection
- •Have any planned ocular and/or lid surgeries 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 test article 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
研究组 & 干预措施
Active
Experimental
干预措施: Rohto Dry-Aid® (Drug)
Active Comparator
Active Comparator
干预措施: Systane® Ultra (Drug)
结局指标
主要结局
Dry Eye Staining
时间窗: 28 days
Dry eye syndrome corneal and conjunctival staining assessment
Dry Eye Symptom Questionnaire
时间窗: 28 days
Symptom assessment questionnaire
Tear Film Break Up Time
时间窗: 28 days
Tear Film Break Up Time after instillation of fluorescein dye
Visual Function Assessment
时间窗: 28 days
Reading Test
次要结局
- Drop Comfort Assessment(Day 1)
- Visual Acuity(28 Days)
- Slit-Lamp Biomicroscopy(28 Days)
- Adverse Event(28 Days)
研究者
研究点 (1)
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