Dry EyeNCT07123584
A Randomized Controlled Trial to Evaluate the Safety and Efficacy of an Oral Supplement in Supporting Vision and Eye Health
A study testing Eye Empower in people with Dry Eye and Eye Fatigue, run by Bio Nature Health at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 45 years and olderHealthy volunteers can take part
- Conditions the study is for
- Dry Eye, Eye Fatigue
- What is being tested?
- Eye Empower
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Nov 2024to 30 Dec 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 45 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
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- 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.
Who cannot join
- 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
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- 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
- Anyone with a history of substance abuse
- Anyone who uses illicit drugs, including cannabis
- Anyone who drinks heavily (i.e., 8 or more alcoholic drinks per week for women or 15 or more alcoholic drinks per week for men)
Trial locations and contacts
1 site in 1 country.
About this study
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
- Being tested
- Eye Empower, Placebo
- Keywords
- Blurred Vision, Red or itchy eyes
- Medical subject headings
- Dry Eye Syndromes, Asthenopia, Erythema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Eye EmpowerDietary supplement
A multi-ingredient oral supplement formulated to support eye health. Daily dose (3 capsules).
PlaceboDietary supplement
Identical gelatin capsules filled with inert rice flour, administered in the same dosage (3 capsules daily).
| Study group | Role | What they receive |
|---|---|---|
| Eye Empower supplement | Experimental | Not described Receives: Dietary Supplement: Eye Empower |
| Placebo | Placebo comparator | Not described Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, Week 1, Week 2, Week 3, Week 4
Secondary outcomes (1)
Change in Perceived Overall Eye Health
Evaluation of participants' self-reported overall eye health using a standardized questionnaire administered weekly throughout the study.
Measured: Baseline, Week 1, Week 2, Week 3, Week 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2025
- Study start6 Nov 2024
- Primary completion30 Dec 2024
- Study completion30 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dry EyeStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 60 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
- NCT07123584
- Sponsor's protocol ID
- 20686
- Status last verified
- Aug 2025
- First submitted
- 8 Aug 2025
- Last updated
- 14 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial to Evaluate the Safety and Efficacy of an Oral Supplement in Supporting Vision and Eye Health
- ClinicalTrials.gov ID
- NCT07123584
- Acronym / sponsor ID
- 20686
- Conditions
- Dry Eye, Eye Fatigue
- Keywords
- Blurred Vision, Red or itchy eyes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Bio Nature HealthIndustry (pharma, biotech, devices)
- Collaborators
- Citruslabs
- Study start
- 6 Nov 2024 (actual)
- Primary completion
- 30 Dec 2024 (actual)
- Study completion
- 30 Dec 2024 (actual)
- First posted
- 14 Aug 2025 (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 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Eye Empower supplement | Experimental | Dietary Supplement: Eye Empower |
| Placebo | Placebo comparator | Dietary Supplement: Placebo |
Who may qualify
- Ages
- 45 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (18 listed)
- 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
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 EmpowerA multi-ingredient oral supplement formulated to support eye health. Daily dose (3 capsules). | Dietary supplement | Eye Empower supplement |
| PlaceboIdentical gelatin capsules filled with inert rice flour, administered in the same dosage (3 capsules daily). | Dietary supplement | Placebo |
Primary outcome
Change in Eye Health Symptoms (Dryness, Irritation, Fatigue, and Visual Acuity)
Time frame: Baseline, Week 1, Week 2, Week 3, Week 4
Assessment of changes in eye dryness, irritation, fatigue, and visual acuity using a self-reported questionnaire administered weekly.
1 secondary outcome
Change in Perceived Overall Eye Health
Time frame: Baseline, Week 1, Week 2, Week 3, Week 4
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 14 Aug 2025.
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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 Dry Eye and Eye Fatigue, 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 9 inclusion and 18 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 14 Aug 2025. 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. Some participants in this study may receive a placebo. 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?
Change in Eye Health Symptoms (Dryness, Irritation, Fatigue, and Visual Acuity) (time frame: Baseline, Week 1, Week 2, Week 3, Week 4). 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 14 Aug 2025.