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

NCT07123584 | Completed

• 1 other identifier: 20686
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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

Keywords

Blurred Vision; Red or itchy eyes

Outcome Measures

Primary Outcomes (1)

• Change in Eye Health Symptoms (Dryness, Irritation, Fatigue, and Visual Acuity)

  Assessment of changes in eye dryness, irritation, fatigue, and visual acuity using a self-reported questionnaire administered weekly.

  Baseline, Week 1, Week 2, Week 3, Week 4

Secondary Outcomes (1)

• Change in Perceived Overall Eye Health

  Baseline, Week 1, Week 2, Week 3, Week 4

Study Arms (2)

Eye Empower supplement

EXPERIMENTAL

Dietary Supplement: Eye Empower

Placebo

PLACEBO COMPARATOR

Dietary Supplement: Placebo

Interventions

Eye Empower DIETARY_SUPPLEMENT

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

Eye Empower supplement

Placebo DIETARY_SUPPLEMENT

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

Placebo

Eligibility Criteria

• Age: 45 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Bio Nature Health: lead
• Citruslabs: collaborator

Study Sites (1)

Citruslabs

Las Vegas, Nevada, 89118, United States

Location

MeSH Terms

Conditions

Dry Eye Syndromes; Asthenopia; Erythema

Condition Hierarchy (Ancestors)

Lacrimal Apparatus Diseases; Eye Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Skin Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 8, 2025
• First Posted: August 14, 2025
• Study Start: November 6, 2024
• Primary Completion: December 30, 2024
• Study Completion: December 30, 2024
• Last Updated: August 14, 2025

Record last verified: 2025-08

Locations

US (1)