Inflammation SymptomsNCT06515457
A Clinical Trial to Evaluate the Efficacy of an Oral Supplement in Supporting Vision and Eye Health
A study testing Eye Empower in people with Inflammation Symptoms and Eye Dryness, run by Bio Nature Health at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Inflammation Symptoms, Eye Dryness, Eye Health
- What is being tested?
- Eye Empower
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Apr 2024to 1 Jun 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 12Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
- Being tested
- Eye Empower
- Keywords
- Vision Health, Eye Empower
- Medical subject headings
- Xerophthalmia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Eye EmpowerDietary supplement
Also called BioNatureHealth Eye Empower
Participants will take three capsules of the Eye Empower supplement daily for three weeks.
| Study group | Role | What they receive |
|---|---|---|
| Eye Empower Supplement Arm | Experimental | Participants in this arm will take three capsules of BioNatureHealth's Eye Empower supplement daily for three weeks. Receives: Dietary Supplement: Eye Empower |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline, Week 1, Week 2, Week 3
Secondary outcomes (1)
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.
Measured: Baseline, Week 1, Week 2, and Week 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2024
- Study start22 Apr 2024
- Primary completion1 Jun 2024
- Study completion1 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Inflammation SymptomsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bio Nature Health
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Citruslabs
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06515457
- Sponsor's protocol ID
- 20425
- Status last verified
- Jul 2024
- First submitted
- 17 Jul 2024
- Last updated
- 23 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Trial to Evaluate the Efficacy of an Oral Supplement in Supporting Vision and Eye Health
- ClinicalTrials.gov ID
- NCT06515457
- Acronym / sponsor ID
- 20425
- Conditions
- Inflammation Symptoms, Eye Dryness, Eye Health
- Keywords
- Vision Health, Eye Empower
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Bio Nature HealthIndustry (pharma, biotech, devices)
- Collaborators
- Citruslabs
- Study start
- 22 Apr 2024 (actual)
- Primary completion
- 1 Jun 2024 (actual)
- Study completion
- 1 Jun 2024 (actual)
- First posted
- 23 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Eye Empower Supplement Arm | Experimental | Dietary Supplement: Eye EmpowerParticipants in this arm will take three capsules of BioNatureHealth's Eye Empower supplement daily for three weeks. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Eye EmpowerAlso: BioNatureHealth Eye EmpowerParticipants will take three capsules of the Eye Empower supplement daily for three weeks. | Dietary supplement | Eye Empower Supplement Arm |
Primary outcome
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.
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.
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.
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.
1 secondary outcome
Improvement in Overall Eye Health
Time frame: Baseline, Week 1, Week 2, and Week 3
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Eye Empower in people with Inflammation Symptoms and Eye Dryness, run by Bio Nature Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improvement in Visual Clarity (time frame: Baseline, Week 1, Week 2, and Week 3). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jul 2024.