NCT02908282已完成不适用
Topical Omega-3 Fatty Acids (REMOGEN® OMEGA) in the Treatment of Dry Eye
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 81
- 试验地点
- 10
- 主要终点
- Tear film stability
研究概览
简要总结
The primary objective of this study is to evaluate the efficacy of REMOGEN® OMEGA in reducing Dry Eye Syndrome (DES) symptoms.
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 (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 81 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female patient between 18 and 80 years of age and in good general health condition.
- •Signed written informed consent.
- •Existence of moderate to severe DES symptoms defined as Break-up time (TBUT) ≤ 10 s (mean of 3 consecutive measurements) and OSDI questionnaire ≥ 20.
排除标准
- •Contraindication for the use of the products (e.g. hypersensitivity to the constituents of the test products) or any study procedure.
- •Concomitant or previous participation in a clinical investigation within the last 3 months.
- •Concomitant therapies/manipulations that affect either the tear film, tear secretion or ocular surface integrity or would alter the effect of the devices being evaluated.
- •Concurrent (systemic) DES-associated diseases that are not on a stable therapy since at least 1 month (therapy not expected to change)
- •Glaucoma that is not on a stable dosage since at least 2 weeks (therapy not expected to change)
- •Any diseases or characteristics judged by the investigator to be incompatible with the assessments and/or procedures for the study evaluation
- •Pregnant or lactating females.
- •Participants of childbearing age who do not use adequate methods of birth control.
- •Subjects unable to understand the informed consent or having a high probability of noncompliance to the study procedures and/or non-completion of the study according to investigator's judgment (e.g. illiteracy, insufficient knowledge of local language).
- •Subjects not capable of contracting and of understanding the nature, risks, significance and implications of the clinical investigation and unable to form a rational intention in the light of these facts.
结局指标
主要结局
Tear film stability
时间窗: Week 4
Tear film breakup time (unit: seconds)
Ocular Surface Disease Index (OSDI©) questionnaire
时间窗: Week 4
次要结局
- Tear film stability(Day 0, Week 12)
- Inflammation marker matrix metalloproteinase 9 (MMP9)(Day 0, Week 4, Week 12)
- OSDI questionnaire(Day 0, Week 12)
- Tear volume(Day 0, Week 4, Week 12)
- Visual acuity (best corrected)(Day 0, Week 4, Week 12)
- TearLab osmolarity test(Day 0, Week 4, Week 12)
- Lid-parallel conjunctival fold (LIPCOF) grading(Day 0, Week 4, Week 12)
- Corneal staining(Day 0, Week 4, Week 12)
- Conjunctival staining(Day 0, Week 4, Week 12)
研究者
研究点 (10)
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