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.
12345Eligibility 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
I can keep my eye open for pictures.
Has read and signed the IRB Informed Consent Document
Your hemoglobin A1c level is 10 or lower.
+15 more
Exclusion Criteria
Who can not receiving ophthalmic imaging
I have an ongoing eye condition.
You are not able to read and sign the informed consent form.
+2 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Observational
The eye is studied in various conditions using advanced ophthalmic imaging devices
1-2 years
Interventional
Participants receive Ocufolin medical food and changes in the eyes are studied
6 months
Follow-up
Participants are monitored for safety and effectiveness after treatment
up to 2 years
Participant Groups
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.
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.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Bascom Palmer Eye InstituteMiami, FL
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Who Is Running the Clinical Trial?
University of MiamiLead Sponsor
References
In vitro inhibitory effect of obtusofolin on the activity of CYP3A4, 2C9, and 2E1. [2021]Obtusofolin is the major active ingredient of Catsia tora L., which possesses the activity of improving eyesight and protecting the optic nerve. Investigation on the interaction of obtusofolin with cytochrome P450 enzymes (CYP450s) could provide a reference for the clinical application of obtusofolin.
Hepatic Uptake Mechanism of Ophiopogonin D Mediated by Organic Anion Transporting Polypeptides. [2018]Ophiopogonin D (OPD) is one of the main active ingredients of SMI (Shenmai injection) which is widely used in clinical practice in China. Our previous study indicated that OPD might be transported from blood into liver mediated by organic anion transporting polypeptides (OATPs/oatps). This study aims to explore the hepatic uptake mechanism of OPD in rat and human.
Ophiopogonin D alleviates diabetic myocardial injuries by regulating mitochondrial dynamics. [2021]Ophiopogonin D (OP-D) is a steroidal saponin extracted from Ophiopogon japonicus (Thunb.) Ker Gawl. (Liliaceae), that has been traditionally used to treat cough, sputum, and thirst in some Asian countries. Recently, various pharmacological roles of OP-D have been identified, including anti-inflammatory, cardioprotective, and anti-cancer effects. However, whether OP-D can prevent diabetic myocardial injury remains unknown.
Ochratoxin A and β2-microglobulin in BEN patients and controls. [2021]Ochratoxin A (OTA) is a mycotoxin naturally occurring in different foods. OTA is arguably a risk factor for Balkan endemic nephropathy (BEN). The aims of this study are to (1) test the OTA-BEN association in BEN-groups and controls and (2) determine whether urine β2-microglobulin, a marker of impaired ability of the kidneys to re-absorb, is related to OTA. BEN patients had significantly higher OTA serum levels. Within the offspring, OTA was significantly related to higher β2-microglobulin excretion. OTA (2005/2006) was related to a higher incidence of BEN after 2008, providing further evidence that OTA is a risk factor for BEN.
Ophiopogonin D inhibits cell proliferation, causes cell cycle arrest at G2/M, and induces apoptosis in human breast carcinoma MCF-7 cells. [2018]To investigate the effects of ophiopogonin D on human breast cancer MCF-7 cells.