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
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.
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.
LycoRed Ltd. is the lead sponsor of 11 studies on the registry; 1 is open to participants now.
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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.
Soft gel capsules without test material
Dietary Supplement: Placebo
Soft gel capsules containing a mixture of tomato extract, lutein, zeaxanthin as well as other phytonutrients and vitamins
Dietary Supplement: Experimental
Soft gel capsules containing a mixture of tomato extract, lutein, zeaxanthin as well as other phytonutrients and vitamins
soft gel capsules without test material
Retinal microcirculation via Heidelberg Retinal Flowmeter
Measures retinal capillary blood flow
Time frame: 3 weeks
Ocular perfusion pressure
intraocular pressure and blood pressure
Time frame: 3 weeks
Retinal photographic oximetry
Measures oxygen content in retinal arteries and veins
Time frame: 3 weeks
Plan to share: No
No publications or documents are linked to this record.
Ran from Mar 2017 to primary completion in Sep 2018, 17 months.
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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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LycoRed Ltd.