NCT02128763已完成3 期
Dry Eye Assessment and Management Study
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 535
- 试验地点
- 27
- 主要终点
- Mean of Change From Baseline in Ocular Surface Disease Index (OSDI) Score at 6 and 12 Months
研究概览
简要总结
The objective of the DREAM study is to evaluate the effectiveness and safety of supplementation with omega-3 fatty acids in relieving the symptoms of moderate to severe dry eye disease.
详细描述
The study is designed to:
- Test the hypothesis that omega-3 supplementation is an effective treatment for Dry Eye Disease (DED) in Primary Clinical Trial.
- Better understand DED by describing and evaluating a comprehensive set of features of DED and treatment over 12 months of observation in a well-characterized group of patients.
- Determine the effects of extended use and discontinuation of omega-3 through the Extension trial.
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
- •Greater than or equal to 2 of the following 4 signs in the same eye at screening and baseline visits (Same signs must be present at Screening and Baseline visits): Conjunctival staining present greater than or equal to 1 (out of possible score of 6 per eye), Corneal fluorescein staining present greater than or equal to 4 (out of a possible score of 15 per eye), Tear film break up time (TBUT) less than or equal to 7 seconds, Schirmer's test greater than or equal to 1 to less than or equal to 7 mm in 5 minutes.
- •Ocular Surface Disease Index (OSDI) score: 25-80 at screening, 21-80 at baseline.
- •Symptoms of DED for greater than or equal to 6 months.
- •Use of or desire to use artificial tears at least 2 times per day in preceding 2 weeks.
- •Ability to swallow large, soft gelcaps
排除标准
- •Allergic to ingredients in supplements or placebo
- •Contact lens wear
- •Pregnant, nursing, or lactating
- •Current ocular infection, inflammation, or acute allergic conjunctivitis
- •History of: ocular herpetic keratitis, ocular surgery in past 6 months, LASIK surgery, use of glaucoma medicine or surgery for glaucoma, liver disease, atrial fibrillation, hemophilia or bleeding tendencies
- •Currently on anticoagulation therapy
- •Eyelid abnormalities or extensive ocular scarring
- •Use of EPA/DHA supplements in excess of 1200 mg per dayi
- •Current use, insufficient washout period, or intent to change specific treatments for dry eye disease
研究组 & 干预措施
Omega-3 supplements
Experimental
Total 2000 mg EPA and 1000 mg DHA per day taken in 5 gelcaps
干预措施: Omega-3 supplements (Drug)
Placebo
Placebo Comparator
Olive oil-5 gelcaps per day
干预措施: Placebo (Drug)
结局指标
主要结局
Mean of Change From Baseline in Ocular Surface Disease Index (OSDI) Score at 6 and 12 Months
时间窗: 12 months
Average of Ocular Surface Disease Index (OSDI) scores from 6 and 12 months minus average of values from screening and eligibility confirmation visits. OSDI scores range from 0 to 100, with a score of 0 indicating no ocular discomfort and higher scores indicating greater symptom severity. The minimal clinically meaningful change in score is 10 points.
次要结局
- Greater Than or Equal to 10 Point Decrease in Ocular Surface Disease Index (OSDI) (at Least 10 Point Improvement in Symptoms)(12 months)
- Change in Brief Ocular Discomfort Index (BODI) Pain Interference Subscale(12 months)
- Change From Baseline in SF-36 Physical Health Subscale(12 months)
- Change From Baseline in SF-36 Mental Health Subscale(12 months)
- Compliance With the Study Treatment Protocol as Measured by Change in Blood Levels of EPA(12 months)
- Compliance With the Study Treatment Protocol as Measured by Change in Blood Levels of DHA(12 months)
- Change in Tear Film Break up Time, in Seconds(12 months)
- Compliance With the Study Treatment Protocol as Measured by Change in Blood Levels of Oleic Acid(12 months)
- Change in Conjunctival Staining Score(12 months)
- Change in Schirmer's Test mm(12 months)
- Change in Corneal Fluorescein Staining Score(12 months)
- Change in Visual Acuity(12 months)
- Change in Use of Artificial Tears and Other Treatments for Dry Eye Disease(12 months)
研究者
研究点 (27)
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