Eye HealthNCT05533658
The Effects of VisionPure™ on Indices of Vision Health and Cognitive Function
A study testing VisionPure Dietary Supplement in people with Eye Health and Vision, run by Applied Science & Performance Institute at 3 sites in United States.
Trial summary
VisionPure™ is a softgel dietary supplement containing fish oil, lutein, zeaxanthin, and vitamin D. The intent of the VisionPure product is to assist in maintaining eye and cognitive health while helping to provide protection against blue throughout the day. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Eye Health, Vision, Cognitive Function
- What is being tested?
- VisionPure Dietary Supplement
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 15 participants
- Where
- 3 sitesUnited States
- Study dates
- 1 Aug 2022to 3 Feb 2023
- 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 18 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male or female
- Age 18-40 years
- English literate
- Willing to sign informed consent form
Who cannot join
- Current cataracts or prior cataract extraction
- Glaucoma
- Uveitis
- Macular hole or traction
- Retinitis pigmentosa
- Significant epiretinal membrane
Show all 16Show fewer
- Dry eye syndrome of any form
- LASIK procedure
- Diagnosed concussion within the last 6 months
- Optic neuropathy
- Neurological disease
- Metabolic disease
- Cardiovascular disease
- Renal disease
- History of previous ocular surgery, trauma, intraocular injections or photocoagulation
- Vitamin D3, omega fatty acids, or fish oil supplementation with the last 6 months
Trial locations and contacts
3 sites in 1 country.
United States3 sites
True Eye Experts - Lutz
Lutz, Florida, 33549
Applied Science and Performance Institute
Tampa, Florida, 33607
True Eye Experts - New Tampa
Tampa, Florida, 33647
About this study
Official title: The Effects of VisionPure™ on Indices of Vision Health and Cognitive Function: A Randomized, Double-Blind, Placebo-Controlled, Parallel Pilot Trial.
VisionPure™ is a softgel dietary supplement containing fish oil, lutein, zeaxanthin, and vitamin D. The intent of the VisionPure product is to assist in maintaining eye and cognitive health while helping to provide protection against blue throughout the day. In this pilot trial, approximately 16 participants will be recruited and randomly assigned to experimental and placebo conditions. Participants will consume 1 serving (2 softgels) per day of their respective study condition for 60 days. Prior to and following the 60 day supplementation period, participants will undergo a series of optometry and cognitive examinations to quantify eye health and cognitive function outcomes.
Read the detailed description
The study design is a randomized, double-blind, placebo-controlled, parallel design, pilot trial. In this pilot trial, approximately 16 participants will be recruited and randomly assigned to experimental and placebo conditions. Participants will consume 1 serving (2 softgels) per day of their respective study condition for 60 days. All study-related procedures will be carried out at 2 locations, The Applied Science and Performance Institute, as well as at True Eye Experts. Both locations are in Tampa, FL. All screening for the study and the signing of all IRB documents will be held at the Applied Science and Performance Institute. Optometry eye examination at Day 0 and Day 60 will be conducted under the supervision of a board-certified O.D. at the True Eye Experts location. Computer-based cognitive assessments using a program called CNS Vital Signs will be carried out at Day 0 and Day 60 at the Applied Science and Performance Institute. The following exams will be carried out: Verbal Memory, Visual Memory, Composite Memory, and Cognitive Attention.
- Conditions
- Eye Health, Vision, Cognitive Function
- Being tested
- VisionPure Dietary Supplement, Placebo
- Keywords
- Fish Oil, Vitamin D, Antioxidant, Eye Health, Cognitive Function, Vision Health
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VisionPure Dietary SupplementDietary supplement
Subjects will consume two softgels capsules of the Treatment (VisionPure) once daily for 60 days. At Day 0, they will come in for a Comprehensive Eye Exam, a National Eye Institute Visual Functioning Questionnaire, and a series of Cognitive Function Exams. After 60 days, subjects will return and repeat the same questionnaires and exams from Day 0.
PlaceboDietary supplement
Subjects will orally consume two softgel capsules of Placebo once daily for 60 days. At Day 0, they will come in for a Comprehensive Eye Exam, a National Eye Institute Visual Functioning Questionnaire, and a series of Cognitive Function Exams. After 60 days, subjects will return and repeat the same questionnaires and exams from Day 0.
| Study group | Role | What they receive |
|---|---|---|
| VisionPure Dietary Supplement | Experimental | One dose (2 softgel capsules) will be consumed once daily for 60 days. A single dose contains: 976mg fish oil (120mg eicosapentaenoic acid, 610 mg docosahexaenoic acid), 20mg lutein, 4mg zeaxanthin isomers, 25mcg vitamin D3. Receives: Dietary Supplement: VisionPure Dietary Supplement |
| Placebo | Placebo comparator | One dose (2 softgel capsules) will be consumed once daily for 60 days. A single dose contains: 727mg organic sunflower oil, 15mg organic lemon essential oil, 1.5mg vitamin E T-70, 0.7mg natural fish flavor. Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Ganglion Cell Complex Thickness
Diagnostic Procedure: Retinal Optical Coherence Tomography
Measured: Day 0, Day 60
Change in Central Retinal Thickness
Diagnostic Procedure: Retinal Optical Coherence Tomography
Measured: Day 0, Day 60
Change in Intraocular Pressure
Diagnostic Procedure: Retinal Optical Coherence Tomography
Measured: Day 0, Day 60
Secondary outcomes (6)
Change in Visual Acuity
Determines the clarity of your distance vision according to the Snellen Chart.
Measured: Day 0, Day 60
Change in Color Vision
Determines the normality of or defectiveness of color vision. Reference Range: 1 to 11 according to Ishihara Plates (>10 is normal, 7 or <7 is deficient).
Measured: Day 0, Day 60
Change in Verbal Memory
How well can an individual recognize, remember, and recall words.
Measured: Day 0, Day 60
Change in Visual Memory
How well can in individual recognize, remember, and recall a combination of words and images.
Measured: Day 0, Day 60
Change in Composite Memory
How well an individual can recognize, remember, and recall a combination of words and images.
Measured: Day 0, Day 60
Change in Cognitive Attention
The ability to handle multiple tasks at once and shift attention.
Measured: Day 0, Day 60
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2022
- Study start1 Aug 2022
- Primary completion30 Jan 2023
- Study completion3 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Eye HealthStudies 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Applied Science & Performance Institute
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- True Eye Experts - New Tampa
- Responsible party
- Sponsor
- Investigators
- Jacob Wilson, Ph.D., Principal investigator, The Applied Science and Performance Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05533658
- Sponsor's protocol ID
- 1221
- Status last verified
- Oct 2022
- First submitted
- 6 Sep 2022
- Last updated
- 26 May 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of VisionPure™ on Indices of Vision Health and Cognitive Function: A Randomized, Double-Blind, Placebo-Controlled, Parallel Pilot Trial.
- ClinicalTrials.gov ID
- NCT05533658
- Acronym / sponsor ID
- 1221
- Conditions
- Eye Health, Vision, Cognitive Function
- Keywords
- Fish Oil, Vitamin D, Antioxidant, Eye Health, Cognitive Function, Vision Health
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Applied Science & Performance InstituteIndustry (pharma, biotech, devices)
- Collaborators
- True Eye Experts - New Tampa
- Study start
- 1 Aug 2022 (actual)
- Primary completion
- 30 Jan 2023 (actual)
- Study completion
- 3 Feb 2023 (actual)
- First posted
- 9 Sep 2022 (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.
VisionPure™ is a softgel dietary supplement containing fish oil, lutein, zeaxanthin, and vitamin D. The intent of the VisionPure product is to assist in maintaining eye and cognitive health while helping to provide protection against blue throughout the day. In this pilot trial, approximately 16 participants will be recruited and randomly assigned to experimental and placebo conditions. Participants will consume 1 serving (2 softgels) per day of their respective study condition for 60 days. Prior to and following the 60 day supplementation period, participants will undergo a series of optometry and cognitive examinations to quantify eye health and cognitive function outcomes.
Detailed description
The study design is a randomized, double-blind, placebo-controlled, parallel design, pilot trial. In this pilot trial, approximately 16 participants will be recruited and randomly assigned to experimental and placebo conditions. Participants will consume 1 serving (2 softgels) per day of their respective study condition for 60 days. All study-related procedures will be carried out at 2 locations, The Applied Science and Performance Institute, as well as at True Eye Experts. Both locations are in Tampa, FL. All screening for the study and the signing of all IRB documents will be held at the Applied Science and Performance Institute. Optometry eye examination at Day 0 and Day 60 will be conducted under the supervision of a board-certified O.D. at the True Eye Experts location. Computer-based cognitive assessments using a program called CNS Vital Signs will be carried out at Day 0 and Day 60 at the Applied Science and Performance Institute. The following exams will be carried out: Verbal Memory, Visual Memory, Composite Memory, and Cognitive Attention.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| VisionPure Dietary Supplement | Experimental | Dietary Supplement: VisionPure Dietary SupplementOne dose (2 softgel capsules) will be consumed once daily for 60 days. A single dose contains: 976mg fish oil (120mg eicosapentaenoic acid, 610 mg docosahexaenoic acid), 20mg lutein, 4mg zeaxanthin isomers, 25mcg vitamin D3. |
| Placebo | Placebo comparator | Dietary Supplement: PlaceboOne dose (2 softgel capsules) will be consumed once daily for 60 days. A single dose contains: 727mg organic sunflower oil, 15mg organic lemon essential oil, 1.5mg vitamin E T-70, 0.7mg natural fish flavor. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Male or female
- Age 18-40 years
- English literate
- Willing to sign informed consent form
Key exclusion criteria (16 listed)
- Current cataracts or prior cataract extraction
- Glaucoma
- Uveitis
- Macular hole or traction
- Retinitis pigmentosa
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 |
|---|---|---|
| VisionPure Dietary SupplementSubjects will consume two softgels capsules of the Treatment (VisionPure) once daily for 60 days. At Day 0, they will come in for a Comprehensive Eye Exam, a National Eye Institute Visual Functioning Questionnaire, and a series of Cognitive Function Exams. After 60 days, subjects will return and repeat the same questionnaires and exams from Day 0. | Dietary supplement | VisionPure Dietary Supplement |
| PlaceboSubjects will orally consume two softgel capsules of Placebo once daily for 60 days. At Day 0, they will come in for a Comprehensive Eye Exam, a National Eye Institute Visual Functioning Questionnaire, and a series of Cognitive Function Exams. After 60 days, subjects will return and repeat the same questionnaires and exams from Day 0. | Dietary supplement | Placebo |
Primary outcome
Change in Ganglion Cell Complex Thickness
Time frame: Day 0, Day 60
Diagnostic Procedure: Retinal Optical Coherence Tomography
Change in Central Retinal Thickness
Time frame: Day 0, Day 60
Diagnostic Procedure: Retinal Optical Coherence Tomography
Change in Intraocular Pressure
Time frame: Day 0, Day 60
Diagnostic Procedure: Retinal Optical Coherence Tomography
6 secondary outcomes
Change in Visual Acuity
Time frame: Day 0, Day 60
Change in Color Vision
Time frame: Day 0, Day 60
Change in Verbal Memory
Time frame: Day 0, Day 60
Change in Visual Memory
Time frame: Day 0, Day 60
Change in Composite Memory
Time frame: Day 0, Day 60
Change in Cognitive Attention
Time frame: Day 0, Day 60
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 26 May 2023.
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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.
Jacob Wilson, Ph.D. principal investigator
The Applied Science and Performance Institute
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing VisionPure Dietary Supplement in people with Eye Health and Vision, run by Applied Science & Performance Institute at 3 sites 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 4 inclusion and 16 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 26 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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 Ganglion Cell Complex Thickness (time frame: Day 0, Day 60). The study lists 3 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 26 May 2023.