Ocular Blood Flow Clinical Trial
Official title:
The Effects of LycoRed Phytonutrient and Vitamin Supplement (a.k.a. LYC-001e) on Ocular Blood Flow
Verified date | February 2019 |
Source | LycoRed Ltd. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 60 |
Est. completion date | December 30, 2018 |
Est. primary completion date | September 1, 2018 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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: - 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 |
Country | Name | City | State |
---|---|---|---|
United States | Glaucoma Research and Diagnostic Center Eugene and Marilyn Glick Eye Institute Indiana University School of Medicine | Indianapolis | Indiana |
Lead Sponsor | Collaborator |
---|---|
LycoRed Ltd. | Indiana University School of Medicine |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Retinal microcirculation via Heidelberg Retinal Flowmeter | Measures retinal capillary blood flow | 3 weeks | |
Secondary | Ocular perfusion pressure | intraocular pressure and blood pressure | 3 weeks | |
Secondary | Retinal photographic oximetry | Measures oxygen content in retinal arteries and veins | 3 weeks |
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