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

July 22, 2024 updated by: Bio Nature 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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
40

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Improvement in Visual Clarity
Time Frame: Baseline, Week 1, Week 2, and Week 3
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
Time Frame: Baseline, Week 1, Week 2, Week 3
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
Time Frame: Baseline, Week 1, Week 2, Week 3
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
Time Frame: Baseline, Week 1, Week 2, Week 3
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Improvement in Overall Eye Health
Time Frame: Baseline, Week 1, Week 2, and Week 3
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Bio Nature Health

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Citruslabs

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 22, 2024

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 17, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 22, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 23, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 23, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 22, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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