Ocufolin for Eye Conditions

Overseen By Jianhua Wang, MD, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Miami

Disqualifiers: Active ocular disease, Recent eye surgery, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

5000 Participants Needed

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. ^{1 2 3 4 5}

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

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.

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.

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

Treatment Details

Interventions

• Ocufolin

Trial Overview 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.

Participant Groups

Group I: Interventional Phase - Ocufolin Group Experimental Treatment 1 Intervention

Participants in this group will receive the Ocufolin medical food for 6 months.

Group II: Observational Phase Group Active Control 1 Intervention

Participants in this group will be studied and followed up for 1-2 years.

Who Is Running the Clinical Trial?

University of Miami

Lead Sponsor

Trials

976

Recruited

423,000+

Findings from Research

Obtusofolin, the main active ingredient in Catsia tora L., significantly inhibits the activity of key cytochrome P450 enzymes (CYP3A4, CYP2C9, and CYP2E1) in a dose-dependent manner, which could affect the metabolism of other drugs.

The inhibition of CYP3A4 by obtusofolin follows a non-competitive model, while CYP2C9 and CYP2E1 are inhibited competitively, suggesting potential drug-drug interactions that warrant further investigation in vivo.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

In vitro inhibitory effect of obtusofolin on the activity of CYP3A4, 2C9, and 2E1. Liu, N., Chen, P., Du, X., et al.[2021]

Ophiopogonin D (OPD) is effectively taken up by rat hepatocytes and human OATP1B1 cells, with specific transport mechanisms involving organic anion transporting polypeptides (OATPs), particularly oatp1b2 in rats and OATP1B1 in humans.

The uptake of OPD is significantly inhibited by certain compounds like rosuvastatin and glycyrrhizic acid, indicating that these transporters play a crucial role in its hepatic absorption, which could impact its therapeutic efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Hepatic Uptake Mechanism of Ophiopogonin D Mediated by Organic Anion Transporting Polypeptides. Zhang, W., Xiong, X., Chen, L., et al.[2018]

Ophiopogonin D (OP-D) significantly reduced blood lipid levels and alleviated mitochondrial injury in diabetic mice, suggesting its potential as a cardioprotective agent against diabetic myocardial injury.

In vitro studies showed that OP-D improved cell survival and mitochondrial function in cardiomyocytes exposed to palmitic acid, indicating that its cardioprotective effects may be linked to the regulation of mitochondrial dynamics.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ophiopogonin D alleviates diabetic myocardial injuries by regulating mitochondrial dynamics. Li, W., Ji, L., Tian, J., et al.[2021]

Patients with Balkan endemic nephropathy (BEN) had significantly higher serum levels of ochratoxin A (OTA), suggesting a strong association between OTA exposure and the disease.

In the offspring of BEN patients, higher levels of OTA were linked to increased excretion of β2-microglobulin, indicating potential kidney impairment related to OTA exposure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ochratoxin A and β2-microglobulin in BEN patients and controls. Yordanova, P., Wilfried, K., Tsolova, S., et al.[2021]

Ophiopogonin D significantly reduces the viability and colony formation of human breast cancer MCF-7 cells in a dose-dependent manner, indicating its potential as an effective treatment.

The mechanism of action involves inducing cell cycle arrest at the G(2)/M phase and promoting apoptosis through the activation of caspase-8 and caspase-9, highlighting its role in inhibiting cancer cell growth.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ophiopogonin D inhibits cell proliferation, causes cell cycle arrest at G2/M, and induces apoptosis in human breast carcinoma MCF-7 cells. Zang, QQ., Zhang, L., Gao, N., et al.[2018]

References

1. England pubmed.ncbi.nlm.nih.gov

In vitro inhibitory effect of obtusofolin on the activity of CYP3A4, 2C9, and 2E1. [2021]

2. France pubmed.ncbi.nlm.nih.gov

Hepatic Uptake Mechanism of Ophiopogonin D Mediated by Organic Anion Transporting Polypeptides. [2018]

3. Ireland pubmed.ncbi.nlm.nih.gov

Ophiopogonin D alleviates diabetic myocardial injuries by regulating mitochondrial dynamics. [2021]

4. Switzerland pubmed.ncbi.nlm.nih.gov

Ochratoxin A and β2-microglobulin in BEN patients and controls. [2021]

5. Netherlands pubmed.ncbi.nlm.nih.gov

Ophiopogonin D inhibits cell proliferation, causes cell cycle arrest at G2/M, and induces apoptosis in human breast carcinoma MCF-7 cells. [2018]