NCT07123584已完成不适用
A Randomized Controlled Trial to Evaluate the Safety and Efficacy of an Oral Supplement in Supporting Vision and Eye Health
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Change in Eye Health Symptoms (Dryness, Irritation, Fatigue, and Visual Acuity)
研究概览
简要总结
This is a 4-week virtual randomized, triple-blinded, placebo-controlled clinical trial evaluating the safety and efficacy of Eye Empower, an oral supplement, in adults aged 45 or older experiencing dry eyes, irritation, and fatigue. Participants take 3 capsules daily and complete self-reported eye health questionnaires weekly.
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
- 45 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Participants who are male or female
- •Age 45 or over
- •Self-reported concerns about all three of the following symptoms over the last 4 weeks:
- •Dry eyes, Irritated eyes, Eye fatigue
- •Self-reported concerns about any of the following symptoms over the last 4 weeks: Sensitivity to blue light, Blurred vision, far or near, Red or itchy eyes, Eye inflammation
- •Generally healthy - do not live with any uncontrolled chronic diseases
- •Willing to avoid using any new prescriptions, over-the-counter medications, supplements, and herbal remedies for the study that target eye health. This includes the use of new prescription eyeglasses or sunglasses
- •If taking oral over-the-counter supplements or herbal remedies targeted at eye health, has been consistently taking these for at least 3 months prior to starting the study, and is willing to maintain this routine for the study duration
- •Willing to maintain their current diet, sleep schedule, and activity level for the duration of the study.
排除标准
- •Any pre-existing chronic conditions that would prevent participants from adhering to the protocol, including cancer, liver, and mental health-related disorders
- •Anyone with diagnosed diabetes (Type I or Type II)
- •Planning to undergo any procedure related to their eye health during the study
- •Planning to undergo any surgeries or invasive treatments for the study duration
- •Has undergone any surgeries or invasive treatments in the last six months
- •History of any major illness in the last three months
- •Anyone currently taking or has taken a supplement with one or more of the active ingredients in the test product in the last month (e.g., turmeric)
- •Started any new medications or supplements that target eye health in the past 3 months
- •Anyone with known severe allergic reactions that may require the use of an EpiPen, including but not limited to a shellfish or a latex allergy
- •Women who are pregnant, breastfeeding, or trying to conceive currently and for the duration of the study
- •Anyone on a medication or herbal supplement that can impact the blood (e.g., blood thinner, anticoagulant, etc.) including but not limited to:
- •Coumadin (Warfarin) Aspirin Plavix (Clopidogrel)
- •Anyone who does not consume animal products for religious and/or personal reasons
- •Unwilling to follow the study protocol
- •Anyone who has undergone any surgeries or invasive treatments in the last three months or has any planned during the study period
- •Anyone with a history of substance abuse
- •Anyone who uses illicit drugs, including cannabis
- •Anyone who drinks heavily (i.e., 8 or more alcoholic drinks per week for women or 15 or more alcoholic drinks per week for men)
结局指标
主要结局
Change in Eye Health Symptoms (Dryness, Irritation, Fatigue, and Visual Acuity)
时间窗: Baseline, Week 1, Week 2, Week 3, Week 4
Assessment of changes in eye dryness, irritation, fatigue, and visual acuity using a self-reported questionnaire administered weekly.
次要结局
- Change in Perceived Overall Eye Health(Baseline, Week 1, Week 2, Week 3, Week 4)
研究者
研究点 (2)
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