A Clinical Trial to Evaluate the Efficacy of an Oral Supplement in Supporting Vision and Eye Health
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Improvement in Visual Clarity
研究概览
简要总结
This study aims to evaluate the efficacy of BioNatureHealth's Eye Empower supplement in supporting vision and eye health. It is a virtual, single-group trial lasting 3 weeks. Participants will take three capsules of the supplement daily and complete questionnaires at Baseline, Week 1, Week 2, and Week 3 to assess visual clarity, dryness, symptoms of inflammation, and sensitivity to blue light.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female at birth, aged 40 or over
- •Self-reported concerns about at least two of the following symptoms: dry eyes, red/itchy/irritated eyes, sensitivity to blue light, blurred vision (far or near)
- •Generally healthy without uncontrolled chronic diseases
- •Willing to avoid using new eye health prescriptions, over-the-counter medications, supplements, and herbal remedies for the study duration
- •Consistent use of current eye health supplements or herbal remedies for at least 3 months prior to the study
- •Willing to maintain current diet, sleep schedule, and activity level during the study
排除标准
- •Pre-existing chronic conditions preventing protocol adherence, including oncological and psychiatric disorders
- •Diagnosed diabetes (Type I or II)
- •Planning to undergo any eye-related procedures during the study
- •Recent surgeries or invasive treatments within the last six months
- •History of major illness within the last three months
- •Recent use of a supplement with active ingredients in the test product
- •Severe allergic reactions requiring an EpiPen, including shellfish allergy
- •Pregnant, breastfeeding, or planning to conceive
- •Use of medications or herbal supplements that impact the blood
- •Non-consumption of animal products for religious or personal reasons
- •Unwillingness to follow the study protocol
- •Anyone with a history of drug or alcohol abuse
结局指标
主要结局
Improvement in Visual Clarity
时间窗: Baseline, Week 1, Week 2, and Week 3
Participants will report on their visual clarity through self-reported questionnaires. The questionnaires will evaluate changes in visual clarity from baseline.
Reduction in Symptoms of Inflammation
时间窗: Baseline, Week 1, Week 2, Week 3
Participants will self-report changes in symptoms of eye inflammation through questionnaires administered at specific intervals during the study. Parameters include redness, irritation, and discomfort.
Reduction in Sensitivity to Blue Light
时间窗: Baseline, Week 1, Week 2, Week 3
Participants will self-report changes in sensitivity to blue light through questionnaires administered at specific intervals during the study. Parameters include the degree of discomfort experienced when exposed to blue light from screens and other sources.
Reduction in Eye Dryness
时间窗: Baseline, Week 1, Week 2, Week 3
Participants will self-report changes in eye dryness through questionnaires administered at specific intervals during the study. Parameters include the frequency and severity of dry eye symptoms.
次要结局
- Improvement in Overall Eye Health(Baseline, Week 1, Week 2, and Week 3)