Ocufolin for Eye Conditions
Trial Summary
What is the purpose of this trial?
The purpose of this study is to determine the clinical application of advanced ophthalmic imaging devices such as optical coherence tomography (OCT), retinal function imager (RFI), slit-lamp biomicroscopy (SLB), PERG in diseased eyes and normal controls. There are two phases in this study. The first phase is an observational phase which studies the eye in various conditions. The second phase is an interventional phase which studies the changes in the eyes after taking an over-the-counter medical food (Ocufolin) for 6 months.
Will I have to stop taking my current medications?
The trial protocol does not specify if you need to stop taking your current medications. However, it mentions that participants can be normotensive (normal blood pressure) with or without medications, suggesting some medications might be allowed.
How does the drug Ocufolin differ from other treatments for eye conditions?
Ocufolin is unique because it contains obtusofolin, an active ingredient known for improving eyesight and protecting the optic nerve, which may interact with specific liver enzymes (CYP450s) to enhance its effects. This mechanism could offer a novel approach compared to other treatments that do not target these enzymes.12345
Research Team
Jianhua Wang, MD, PHD
Principal Investigator
Bascom Palmer Eye Institute, University of Miami, Miami, FL
Eligibility Criteria
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.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Observational
The eye is studied in various conditions using advanced ophthalmic imaging devices
Interventional
Participants receive Ocufolin medical food and changes in the eyes are studied
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Ocufolin
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Miami
Lead Sponsor