A Randomized Controlled Trial to Evaluate the Safety and Efficacy of an Oral Supplement in Suppor… (NCT07123584) | Clinical Trial Compass
CompletedNot Applicable
A Randomized Controlled Trial to Evaluate the Safety and Efficacy of an Oral Supplement in Supporting Vision and Eye Health
United States60 participantsStarted 2024-11-06
Plain-language summary
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.
Who can participate
Age range45 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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.
Exclusion Criteria:
* 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
* His…
What they're measuring
1
Change in Eye Health Symptoms (Dryness, Irritation, Fatigue, and Visual Acuity)