A Randomized Controlled Trial to Evaluate the Safety and Efficacy of an Oral Supplement in Supporting Vision and Eye Health

Bio Nature Health

Status

Completed

Conditions

Dry Eye

Eye Fatigue

Treatments

Dietary Supplement: Eye Empower

Dietary Supplement: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT07123584

20686

Details and patient eligibility

About

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.

Enrollment

60 patients

Sex

All

Ages

45+ years old

Volunteers

Accepts Healthy Volunteers

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)