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

This study aims to evaluate the efficacy of BioNatureHealth's Eye Empower supplement in supporting vision and eye health. It is a virtual, single-group trial lasting 3 weeks. Participants will take three capsules of the supplement daily and complete questionnaires at Baseline, Week 1, Week 2, and Week 3 to assess visual clarity, dryness, symptoms of inflammation, and sensitivity to blue light.

Study Overview

• Status: Completed
• Conditions: Eye Health; Eye Dryness; Inflammation Symptoms
• Intervention / Treatment: Dietary supplement: Eye Empower

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Santa Monica, California, United States, 90404
      • Citruslabs

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Male or female at birth, aged 40 or over
• Self-reported concerns about at least two of the following symptoms: dry eyes, red/itchy/irritated eyes, sensitivity to blue light, blurred vision (far or near)
• Generally healthy without uncontrolled chronic diseases
• Willing to avoid using new eye health prescriptions, over-the-counter medications, supplements, and herbal remedies for the study duration
• Consistent use of current eye health supplements or herbal remedies for at least 3 months prior to the study
• Willing to maintain current diet, sleep schedule, and activity level during the study

Exclusion Criteria:

• Pre-existing chronic conditions preventing protocol adherence, including oncological and psychiatric disorders
• Diagnosed diabetes (Type I or II)
• Planning to undergo any eye-related procedures during the study
• Recent surgeries or invasive treatments within the last six months
• History of major illness within the last three months
• Recent use of a supplement with active ingredients in the test product
• Severe allergic reactions requiring an EpiPen, including shellfish allergy
• Pregnant, breastfeeding, or planning to conceive
• Use of medications or herbal supplements that impact the blood
• Non-consumption of animal products for religious or personal reasons
• Unwillingness to follow the study protocol
• Anyone with a history of drug or alcohol abuse

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Eye Empower Supplement Arm; Participants in this arm will take three capsules of BioNatureHealth's Eye Empower supplement daily for three weeks.	Dietary supplement: Eye Empower; Participants will take three capsules of the Eye Empower supplement daily for three weeks.; Other Names: BioNatureHealth Eye Empower

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Improvement in Visual Clarity	Participants will report on their visual clarity through self-reported questionnaires. The questionnaires will evaluate changes in visual clarity from baseline.	Baseline, Week 1, Week 2, and Week 3
Reduction in Eye Dryness	Participants will self-report changes in eye dryness through questionnaires administered at specific intervals during the study. Parameters include the frequency and severity of dry eye symptoms.	Baseline, Week 1, Week 2, Week 3
Reduction in Symptoms of Inflammation	Participants will self-report changes in symptoms of eye inflammation through questionnaires administered at specific intervals during the study. Parameters include redness, irritation, and discomfort.	Baseline, Week 1, Week 2, Week 3
Reduction in Sensitivity to Blue Light	Participants will self-report changes in sensitivity to blue light through questionnaires administered at specific intervals during the study. Parameters include the degree of discomfort experienced when exposed to blue light from screens and other sources.	Baseline, Week 1, Week 2, Week 3

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Improvement in Overall Eye Health	Participants will report on their overall eye health through self-reported questionnaires. The questionnaires will assess changes in symptoms such as eye dryness, symptoms of inflammation, and sensitivity to blue light.	Baseline, Week 1, Week 2, and Week 3

Collaborators and Investigators

• Sponsor: Bio Nature Health
• Collaborators: Citruslabs

Study record dates

Study Major Dates

• Study Start (Actual): April 22, 2024
• Primary Completion (Actual): June 1, 2024
• Study Completion (Actual): June 1, 2024

Study Registration Dates

• First Submitted: July 17, 2024
• First Submitted That Met QC Criteria: July 22, 2024
• First Posted (Actual): July 23, 2024

Study Record Updates

• Last Update Posted (Actual): July 23, 2024
• Last Update Submitted That Met QC Criteria: July 22, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Keywords: Vision Health; Eye Empower
• Additional Relevant MeSH Terms: Pathologic Processes; Inflammation
• Other Study ID Numbers: 20425

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No