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
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 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)
研究组 & 干预措施
Eye Empower supplement
Experimental
干预措施: Eye Empower (Dietary Supplement)
Placebo
Placebo Comparator
干预措施: Placebo (Dietary Supplement)
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 (1)
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