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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
Normotensive with or without medications
Clinical diagnosis of Alzheimer's Disease, mild cognitive impairment, multiple sclerosis, dry eye, myopia, diabetics, and stroke
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2 years
Awards & highlights

Study 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 below
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My blood pressure is normal, with or without medication.
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I have been diagnosed with Alzheimer's, mild cognitive impairment, MS, dry eye, myopia, diabetes, or have had a stroke.
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I consider myself to be in good health.
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I am over 18 and can legally consent.
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I can keep my eye open for pictures.
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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.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2 years for reporting.

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 more
Secondary 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
898 Previous Clinical Trials
404,651 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

Ocufolin Clinical Trial Eligibility Overview. Trial Name: NCT03135327 — N/A
Diabetic Retinopathy Research Study Groups: Interventional Phase - Ocufolin Group, Observational Phase Group
Diabetic Retinopathy Clinical Trial 2023: Ocufolin Highlights & Side Effects. Trial Name: NCT03135327 — N/A
Ocufolin 2023 Treatment Timeline for Medical Study. Trial Name: NCT03135327 — N/A
Diabetic Retinopathy Patient Testimony for trial: Trial Name: NCT03135327 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this research study open to adults aged 18 and over?

"The criteria for entry into this study necessitates that participants are between the ages of 18 and 99. Aside from this trial, there are additional 122 studies catered to those under 18 years old and 813 more suitable for individuals above 65."

Answered by AI

Is recruitment for participants ongoing?

"The trial is still open for recruitment, as indicated by information on clinicaltrials.gov; the posting was placed on January 1st 2007 and revised October 18th 2022."

Answered by AI

What is the total amount of participants included in this research endeavor?

"Affirmative, the trial is currently open to participants. It was initially posted on January 1st 2007 and its latest update occurred on October 18th 2022. A total of 5000 individuals are needed across a single site for this research endeavour."

Answered by AI

What criteria must a participant fulfill to qualify for this clinical trial?

"This clinical trial seeks to enroll around 5000 participants with diabetic retinopathy aged between 18 and 99. Eligibility requirements must be met in order to join the study."

Answered by AI

Who else is applying?

What state do they live in?
Florida
How old are they?
18 - 65
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
What site did they apply to?
Bascom Palmer Eye Institute
How many prior treatments have patients received?
1
0

What questions have other patients asked about this trial?

How long do visits take and is there compensation for travel/time?
PatientReceived 1 prior treatment

Why did patients apply to this trial?

I have used restasis and over the counter eye drops which help some.
PatientReceived no prior treatments
~441 spots leftby Dec 2025