ClinicalTrials.gg
CompletedNCT03068377Updated Feb 26, 2019

The Effects of LycoRed Phytonutrient and Vitamin Supplement (a.k.a. LYC-001e) on Ocular Blood Flow

An interventional study of Experimental and Placebo in Ocular Blood Flow, sponsored by LycoRed Ltd.. Completed at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-02-26.

Sponsored by LycoRed Ltd. · Not applicable, Interventional, and Supportive care

Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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 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.

02

Conditions studied

  • Ocular Blood Flow

Keywords

  • lycopene
  • eye
  • vessel function
03

In context

Lead sponsor

LycoRed Ltd. is the lead sponsor of 11 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • 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
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
60 participants (actual)

Study arms

  • Placebo comparator
    Placebo

    Soft gel capsules without test material

    Dietary Supplement: Placebo

  • Experimental
    Experimental

    Soft gel capsules containing a mixture of tomato extract, lutein, zeaxanthin as well as other phytonutrients and vitamins

    Dietary Supplement: Experimental

Interventions

  • Dietary supplementExperimental

    Soft gel capsules containing a mixture of tomato extract, lutein, zeaxanthin as well as other phytonutrients and vitamins

  • Dietary supplementPlacebo

    soft gel capsules without test material

06

What researchers measure

Primary outcomes

  1. Retinal microcirculation via Heidelberg Retinal Flowmeter

    Measures retinal capillary blood flow

    Time frame: 3 weeks

Secondary outcomes

  1. Ocular perfusion pressure

    intraocular pressure and blood pressure

    Time frame: 3 weeks

  2. Retinal photographic oximetry

    Measures oxygen content in retinal arteries and veins

    Time frame: 3 weeks

07

Study locations

1 site
  • Glaucoma Research and Diagnostic Center Eugene and Marilyn Glick Eye Institute Indiana University School of Medicine
    Indianapolis, Indiana 46202, United States
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Mar 2017 to primary completion in Sep 2018, 17 months.

How these figures are worked out, and which studies are left out of them.

Registered
Feb 26, 2017
First posted
Mar 1, 2017
StartActual
Mar 20, 2017
Primary completionActual
Sep 1, 2018
CompletionActual
Dec 30, 2018
Last update
Feb 26, 2019
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Feb 26, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03068377
Lead sponsor
LycoRed Ltd.
Collaborators
Indiana University
Responsible party
Sponsor
First posted
Mar 1, 2017
Start date
Mar 20, 2017
Primary completion
Sep 1, 2018
Completion
Dec 30, 2018
Last update
Feb 26, 2019

Study contacts

Alon Harris, MS, PhD
principal investigator · Indiana University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Feb 2019. You cannot join it, but the record below documents what was studied.

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