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

NCT06515457 | Completed

• 1 other identifier: 20425
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Inflammation Symptoms; Eye Dryness; Eye Health

Keywords

Vision Health; Eye Empower

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (1)

• Improvement in Overall Eye Health

  Baseline, Week 1, Week 2, and Week 3

Study Arms (1)

Eye Empower Supplement Arm

EXPERIMENTAL

Participants in this arm will take three capsules of BioNatureHealth's Eye Empower supplement daily for three weeks.

Dietary Supplement: Eye Empower

Interventions

Eye Empower DIETARY_SUPPLEMENT

Participants will take three capsules of the Eye Empower supplement daily for three weeks.

Also known as: BioNatureHealth Eye Empower

Eye Empower Supplement Arm

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Bio Nature Health: lead
• Citruslabs: collaborator

Study Sites (1)

Citruslabs

Santa Monica, California, 90404, United States

Location

MeSH Terms

Conditions

Xerophthalmia

Condition Hierarchy (Ancestors)

Conjunctival Diseases; Eye Diseases; Dry Eye Syndromes; Lacrimal Apparatus Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 17, 2024
• First Posted: July 23, 2024
• Study Start: April 22, 2024
• Primary Completion: June 1, 2024
• Study Completion: June 1, 2024
• Last Updated: July 23, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)