Ocular Blood FlowNCT03068377
The Effects of LycoRed Phytonutrient and Vitamin Supplement (a.k.a. LYC-001e) on Ocular Blood Flow
A study testing Experimental in people with Ocular Blood Flow, run by LycoRed Ltd. at 1 site in United States.
Trial summary
Objectives:To determine LYC-001e's influences on ocular blood flow Ocular blood flow has been implicated as a parameter relevant to eye health and involved in the disease process of several ophthalmic pathologies including AMD, glaucoma, and diabetes We hypothesis that LYC-001e will increase measures of ocular blood… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Ocular Blood Flow
- What is being tested?
- Experimental
- 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
- 20 Mar 2017to 30 Dec 2018
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy males and females of 18 years of age or older and free of any eye disease (other than myopia)
- Willing to sign an informed consent statement and able to comply with the requirements of the examination
Who cannot join
- Women who are pregnant or lactating or who plan to become pregnant (self reporting) within the duration of the study or within one month after study completion.
- Receiving medications or dietary supplements known to have any interaction with the study supplements.
- Smoker during last ten years (self reporting)
- Concurrent use of any of the components of the study supplement
- Individuals with narrow anterior chamber angles
Trial locations and contacts
1 site in 1 country.
United States1 site
Glaucoma Research and Diagnostic Center Eugene and Marilyn Glick Eye Institute Indiana University School of Medicine
Indianapolis, Indiana, 46202
About this study
Objectives:To determine LYC-001e's influences on ocular blood flow Ocular blood flow has been implicated as a parameter relevant to eye health and involved in the disease process of several ophthalmic pathologies including AMD, glaucoma, and diabetes We hypothesis that LYC-001e will increase measures of ocular blood flow in healthy individuals
Methods: This is a single-phase, randomized, parallel, double blind , comparative study of LYC-001e versus placebo on ocular blood vessels in healthy individuals.
Read the detailed description
Age-Related Eye Disease (ARED) is a group of conditions that are associated with an increased risk of manifesting later in life, and include: Age-related Macular Degeneration (AMD), cataract, diabetic retinopathy, glaucoma, dry eye, and low vision. AMD and cataract are the leading causes of visual impairment in the United States. According to the National Eye Institute, approximately 1.7 million Americans suffer from some form of AMD, and over 1.5 million cataract surgeries are performed annually.
Although there are established risk factors, such as smoking and diabetes, cataracts are generally considered a consequence of ageing. The National Eye Institute estimates more than half of Americans will have cataracts or have had cataract surgery by the time they reach 80 years old. Additionally, AMD is the leading cause of central vision loss in developed countries and affects 13.4% of all adults aged 60 years and older.
It is estimated that the number of patients with AMD in the U.S. will double in 2050, based on 2010 demographics.
The severity and irreversibility of ocular pathology have created interest in researching ways to either prevent or slow their progression. Nutritional methods have been demonstrated to improve microvascular function in hypertensive patients, however diet modifications are infrequently well established and maintained in the American population.
Over the last 15 years, researchers focused on the role of the AREDS vitamin formulation on age related eye disease, specifically as it pertains to the development and progression of AMD and cataracts. While the benefit of AREDS supplementation has proven beneficial for AMD, its role in the prevention of cataract and/or glaucoma development has not been confirmed. However, with evidence suggesting that some combination supplements do provide potential risk reduction, it is our belief that further studies are needed to elucidate the role of combination nutriceuticals for the prevention of cataracts.
Lycored Nutrient Complex for eyes (LNC for eyes) a.k.a. (LYC-001e) is a commercially available multivitamin formula nutraceutical product that also contains a standardized tomato extract. Research by Armoza, et al. has shown multiple benefits of tomato extract as it pertains to limiting inflammatory processes of the vascular endothelium. Along with the previously mentioned benefits of nutraceuticals, diminished endothelial damage may result in increased ocular blood flow and alter the progression of Age Related Eye Diseases.
This is an important research consideration as ocular blood flow has been implicated in the disease process of several ophthalmic pathologies including AMD, glaucoma, and diabetes.
- Conditions
- Ocular Blood Flow
- Being tested
- Experimental, Placebo
- Keywords
- lycopene, eye, vessel function
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExperimentalDietary supplement
Soft gel capsules containing a mixture of tomato extract, lutein, zeaxanthin as well as other phytonutrients and vitamins
PlaceboDietary supplement
soft gel capsules without test material
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Soft gel capsules without test material Receives: Dietary Supplement: Placebo |
| Experimental | Experimental | Soft gel capsules containing a mixture of tomato extract, lutein, zeaxanthin as well as other phytonutrients and vitamins Receives: Dietary Supplement: Experimental |
What is being measured
The primary outcome is the main question the study is designed to answer.
Retinal microcirculation via Heidelberg Retinal Flowmeter
Measures retinal capillary blood flow
Measured: 3 weeks
Secondary outcomes (2)
Ocular perfusion pressure
intraocular pressure and blood pressure
Measured: 3 weeks
Retinal photographic oximetry
Measures oxygen content in retinal arteries and veins
Measured: 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2017
- Study start20 Mar 2017
- Primary completion1 Sep 2018
- Study completion30 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ocular Blood FlowStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Single-phase, randomized, parallel, double blind , comparative study of LYC-001e versus placebo on ocular blood vessels in healthy individuals
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- LycoRed Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Indiana University
- Responsible party
- Sponsor
- Investigators
- Alon Harris, MS, PhD, Principal investigator, Indiana University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03068377
- Sponsor's protocol ID
- LYC-001e
- Status last verified
- Feb 2019
- First submitted
- 26 Feb 2017
- Last updated
- 26 Feb 2019
- 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 26 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of LycoRed Phytonutrient and Vitamin Supplement (a.k.a. LYC-001e) on Ocular Blood Flow
- ClinicalTrials.gov ID
- NCT03068377
- Acronym / sponsor ID
- LYC-001e
- Conditions
- Ocular Blood Flow
- Keywords
- lycopene, eye, vessel function
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- LycoRed Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Indiana University
- Study start
- 20 Mar 2017 (actual)
- Primary completion
- 1 Sep 2018 (actual)
- Study completion
- 30 Dec 2018 (actual)
- First posted
- 1 Mar 2017 (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.
Objectives:To determine LYC-001e's influences on ocular blood flow Ocular blood flow has been implicated as a parameter relevant to eye health and involved in the disease process of several ophthalmic pathologies including AMD, glaucoma, and diabetes We hypothesis that LYC-001e will increase measures of ocular blood flow in healthy individuals
Methods: This is a single-phase, randomized, parallel, double blind , comparative study of LYC-001e versus placebo on ocular blood vessels in healthy individuals.
Detailed description
Age-Related Eye Disease (ARED) is a group of conditions that are associated with an increased risk of manifesting later in life, and include: Age-related Macular Degeneration (AMD), cataract, diabetic retinopathy, glaucoma, dry eye, and low vision. AMD and cataract are the leading causes of visual impairment in the United States. According to the National Eye Institute, approximately 1.7 million Americans suffer from some form of AMD, and over 1.5 million cataract surgeries are performed annually.
Although there are established risk factors, such as smoking and diabetes, cataracts are generally considered a consequence of ageing. The National Eye Institute estimates more than half of Americans will have cataracts or have had cataract surgery by the time they reach 80 years old. Additionally, AMD is the leading cause of central vision loss in developed countries and affects 13.4% of all adults aged 60 years and older.
It is estimated that the number of patients with AMD in the U.S. will double in 2050, based on 2010 demographics.
The severity and irreversibility of ocular pathology have created interest in researching ways to either prevent or slow their progression. Nutritional methods have been demonstrated to improve microvascular function in hypertensive patients, however diet modifications are infrequently well established and maintained in the American population.
Over the last 15 years, researchers focused on the role of the AREDS vitamin formulation on age related eye disease, specifically as it pertains to the development and progression of AMD and cataracts. While the benefit of AREDS supplementation has proven beneficial for AMD, its role in the prevention of cataract and/or glaucoma development has not been confirmed. However, with evidence suggesting that some combination supplements do provide potential risk reduction, it is our belief that further studies are needed to elucidate the role of combination nutriceuticals for the prevention of cataracts.
Lycored Nutrient Complex for eyes (LNC for eyes) a.k.a. (LYC-001e) is a commercially available multivitamin formula nutraceutical product that also contains a standardized tomato extract. Research by Armoza, et al. has shown multiple benefits of tomato extract as it pertains to limiting inflammatory processes of the vascular endothelium. Along with the previously mentioned benefits of nutraceuticals, diminished endothelial damage may result in increased ocular blood flow and alter the progression of Age Related Eye Diseases.
This is an important research consideration as ocular blood flow has been implicated in the disease process of several ophthalmic pathologies including AMD, glaucoma, and diabetes.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Single-phase, randomized, parallel, double blind , comparative study of LYC-001e versus placebo on ocular blood vessels in healthy individuals
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Dietary Supplement: PlaceboSoft gel capsules without test material |
| Experimental | Experimental | Dietary Supplement: ExperimentalSoft gel capsules containing a mixture of tomato extract, lutein, zeaxanthin as well as other phytonutrients and vitamins |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Healthy males and females of 18 years of age or older and free of any eye disease (other than myopia)
- Willing to sign an informed consent statement and able to comply with the requirements of the examination
Key exclusion criteria (5 listed)
- Women who are pregnant or lactating or who plan to become pregnant (self reporting) within the duration of the study or within one month after study completion.
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 |
|---|---|---|
| ExperimentalSoft gel capsules containing a mixture of tomato extract, lutein, zeaxanthin as well as other phytonutrients and vitamins | Dietary supplement | Experimental |
| Placebosoft gel capsules without test material | Dietary supplement | Placebo |
Primary outcome
Retinal microcirculation via Heidelberg Retinal Flowmeter
Time frame: 3 weeks
Measures retinal capillary blood flow
2 secondary outcomes
Ocular perfusion pressure
Time frame: 3 weeks
Retinal photographic oximetry
Time frame: 3 weeks
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 Feb 2019.
- 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.
Alon Harris, MS, PhD principal investigator
Indiana University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Experimental in people with Ocular Blood Flow, run by LycoRed Ltd. 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 2 inclusion and 5 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 Feb 2019. 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?
Retinal microcirculation via Heidelberg Retinal Flowmeter (time frame: 3 weeks). 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 Feb 2019.