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Ocufolin for Eye Conditions
N/A
Recruiting
Led By Jianhua Wang, MD, PhD
Research Sponsored by University of Miami
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Self-reported normal healthy subjects
Has clear corneas and crystalline lens
Must not have
Has an active ocular disease
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2 years
Awards & highlights
Summary
This trial will help researchers understand if these devices can be used to study different eye conditions and if Ocufolin can help improve vision.
Who is the study for?
This trial is for adults with clear vision of at least 20/80 who have conditions like dementia, MS, dry eye, diabetic retinopathy, or near-sightedness. They must be able to undergo advanced eye imaging and have had no recent eye surgery or injury. People with active ocular diseases or intolerance to bright light during imaging cannot participate.Check my eligibility
What is being tested?
The study first observes the eyes using technologies like OCT and RFI. Then it tests if taking Ocufolin—a medical food—over six months can change the eyes' condition in people with various ophthalmic disorders compared to normal healthy subjects.See study design
What are the potential side effects?
Since Ocufolin is an over-the-counter medical food rather than a drug, specific side effects are not listed; however, any potential adverse reactions related to its intake will be monitored throughout the trial.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I consider myself to be in good health.
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My corneas and lens are clear.
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I have a specific genetic mutation and mild to moderate eye blood vessel issues.
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I have not had eye surgery or an injury in the last 6 months.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have an ongoing eye condition.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 2 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Conjunctival vasculature by functional slit-lamp (FSLB)
Corneal epithelial thickness
Retinal microstructure using OCT.
+2 moreSecondary outcome measures
Conjunctival blood flow velocity by functional slit-lamp (FSLB)
Retinal blood flow velocity by retinal function imager (RFI)
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Interventional Phase - Ocufolin GroupExperimental Treatment1 Intervention
Participants in this group will receive the Ocufolin medical food for 6 months.
Group II: Observational Phase GroupActive Control1 Intervention
Participants in this group will be studied and followed up for 1-2 years.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ocufolin
2017
N/A
~30
Find a Location
Who is running the clinical trial?
University of MiamiLead Sponsor
918 Previous Clinical Trials
407,629 Total Patients Enrolled
1 Trials studying Diabetic Retinopathy
3,000 Patients Enrolled for Diabetic Retinopathy
Jianhua Wang, MD, PhDPrincipal InvestigatorBascom Palmer Eye Institute, University of Miami, Miami, FL
4 Previous Clinical Trials
161 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have an ongoing eye condition.I can keep my eye open for pictures.Your hemoglobin A1c level is 10 or lower.My blood pressure is normal, with or without medication.Your blood homocysteine level is higher than 9.You do not have damage to the blood vessels in your retina or swelling in the center of your retina.You are not able to read and sign the informed consent form.I have been diagnosed with Alzheimer's, mild cognitive impairment, MS, dry eye, myopia, diabetes, or have had a stroke.I have had eye surgery or an injury within the last 6 months.I consider myself to be in good health.I am over 18 and can legally consent.I have been diagnosed with Alzheimer's, mild cognitive impairment, MS, dry eye, myopia, diabetes, or have had a stroke.Your eyesight is 20/80 or better.You are not able to handle bright light during imaging.I can keep my eye open for pictures.I consider myself to be in good health.My corneas and lens are clear.I have a specific genetic mutation and mild to moderate eye blood vessel issues.I have not had eye surgery or an injury in the last 6 months.This study is only for observing and gathering information about the participants.
Research Study Groups:
This trial has the following groups:- Group 1: Interventional Phase - Ocufolin Group
- Group 2: Observational Phase Group
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Diabetic Retinopathy Patient Testimony for trial: Trial Name: NCT03135327 — N/A
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