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

NCT ID: NCT07123584

Last Updated: 2025-08-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-11-06
• Study Completion Date: 2024-12-30

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.

Conditions

Dry Eye; Eye Fatigue

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Eye Empower supplement

Group Type: EXPERIMENTAL

Eye Empower

Intervention Type: DIETARY_SUPPLEMENT

A multi-ingredient oral supplement formulated to support eye health. Daily dose (3 capsules).

Placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DIETARY_SUPPLEMENT

Identical gelatin capsules filled with inert rice flour, administered in the same dosage (3 capsules daily).

Interventions

Eye Empower

A multi-ingredient oral supplement formulated to support eye health. Daily dose (3 capsules).

Intervention Type: DIETARY_SUPPLEMENT

Placebo

Identical gelatin capsules filled with inert rice flour, administered in the same dosage (3 capsules daily).

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

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)

• Minimum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Citruslabs

INDUSTRY

Sponsor Role: collaborator

Bio Nature Health

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Citruslabs

Las Vegas, Nevada, United States

Countries

United States

Other Identifiers

20686

Identifier Type: -

Identifier Source: org_study_id