Dry Eye, Eye Fatigue
Conditions
Keywords
Blurred Vision, Red or itchy eyes
Brief 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.
Interventions
DIETARY_SUPPLEMENTEye Empower
A multi-ingredient oral supplement formulated to support eye health. Daily dose (3 capsules).
DIETARY_SUPPLEMENTPlacebo
Identical gelatin capsules filled with inert rice flour, administered in the same dosage (3 capsules daily).
Sponsors
Citruslabs
Bio Nature Health
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
45 Years to No maximum
Healthy volunteers
Yes
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 * 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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Eye Health Symptoms (Dryness, Irritation, Fatigue, and Visual Acuity) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Perceived Overall Eye Health | Baseline, Week 1, Week 2, Week 3, Week 4 | Evaluation of participants' self-reported overall eye health using a standardized questionnaire administered weekly throughout the study. |
Countries
United States
Outcome results
None listed