What is the mechanism of action of this treatment?

Common treatments for glaucoma primarily aim to reduce intraocular pressure (IOP) to prevent damage to the optic nerve. Medications such as prostaglandin analogs increase the outflow of aqueous humor, while beta-blockers and carbonic anhydrase inhibitors reduce its production. Neuroprotective strategies, like those being studied in GlaucoCetin, focus on supporting and protecting optic nerve cells from degeneration. This is crucial for glaucoma patients as preserving the health of optic nerve cells can slow disease progression and help maintain vision.

What side effects are associated with this type of intervention?

Common treatments for glaucoma include medications such as prostaglandin analogs, beta-blockers, alpha agonists, and carbonic anhydrase inhibitors, as well as surgical interventions. Prostaglandin analogs can cause eye redness, eyelash growth, and changes in iris color. Beta-blockers may lead to systemic side effects like bradycardia and respiratory issues. Alpha agonists can cause dry mouth, fatigue, and allergic reactions. Carbonic anhydrase inhibitors might result in a metallic taste, frequent urination, and tingling in fingers and toes. Surgical treatments can have risks such as infection, bleeding, and vision changes. For treatments like GlaucoCetin, which aim to support and protect optic nerve cells, specific side effects are not well-documented, but general side effects of supplements can include gastrointestinal discomfort and allergic reactions.

What prior FDA approvals exist?

The FDA has approved several drugs for the treatment of glaucoma, primarily focusing on reducing intraocular pressure to prevent optic nerve damage. These include prostaglandin analogs (e.g., latanoprost), beta-blockers (e.g., timolol), alpha agonists (e.g., brimonidine), and carbonic anhydrase inhibitors (e.g., dorzolamide). While these treatments primarily aim to lower intraocular pressure, emerging therapies like GlaucoCetin are being studied for their potential to support and protect optic nerve cells directly, offering a novel approach to glaucoma management.

What other types of research exist?

Promising novel alternatives to GlaucoCetin for glaucoma patients in 2024 include: 1) Neuroprotective agents such as brimonidine, which has shown potential in protecting retinal ganglion cells. 2) Gene therapy approaches targeting specific genetic mutations associated with glaucoma. 3) Stem cell therapy aimed at regenerating damaged optic nerve cells. 4) Antioxidant-rich formulations that reduce oxidative stress in the optic nerve. 5) Advanced surgical techniques like minimally invasive glaucoma surgery (MIGS) to reduce intraocular pressure and prevent further optic nerve damage.

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Dietary Supplement

GlaucoCetin for Glaucoma

N/A

Recruiting

Led By Natasha N Kolomeyer, MD

Research Sponsored by Wills Eye

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 20 minute questionnaires during a 6 month period

Awards & highlights

Study Summary

This trial is testing whether a daily medical food can improve the vision of glaucoma patients.

Who is the study for?

This trial is for people aged 40-80 with open-angle glaucoma, controlled eye pressure, and good visual acuity. Participants must have specific types of visual field defects but no other significant eye diseases or recent surgeries. They shouldn't be on certain medications like nitroglycerin or anti-seizure drugs, nor should they have uncontrolled blood pressure or diabetes.Check my eligibility

What is being tested?

The study tests GlaucoCetin, a medical food designed to protect optic nerve cells in glaucoma patients against a placebo over six months. Patients are randomly chosen to receive either the treatment or placebo to see if there's an improvement in vision.See study design

What are the potential side effects?

Potential side effects aren't detailed here but could relate to ingredients in GlaucoCetin such as Curcumin and Ginkgo Biloba which may cause digestive upset or allergic reactions in some individuals.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 20 minute questionnaires during a 6 month period

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~20 minute questionnaires during a 6 month period

This trial's timeline: 3 weeks for screening, Varies for treatment, and 20 minute questionnaires during a 6 month period for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Visual Field Mean Deviation

Secondary outcome measures

Perceived Quality of Life Improvement

Perceived Quality of Life Improvement measured by National Eye Institute Visual Function Questionnaire 25 (NEI VFQ-25)

Trial Design

4Treatment groups

Active Control

Placebo Group

Group I: GlaucoCetin Peripheral GroupActive Control1 Intervention

Primary Open Angle Glaucoma participants who meet inclusion exclusion criteria with peripheral visual field loss will be randomly assigned GlaucoCetin, a medical food in capsule form.

Group II: GlaucoCetin Central GroupActive Control1 Intervention

Primary Open Angle Glaucoma participants who meet inclusion exclusion criteria with central visual field loss will be randomly assigned GlaucoCetin, a medical food in capsule form.

Group III: Placebo Peripheral GroupPlacebo Group1 Intervention

Primary Open Angle Glaucoma participants who meet inclusion exclusion criteria with peripheral visual field loss will be randomly assigned a placebo, with no nutritional value, in capsule form.

Group IV: Placebo Central GroupPlacebo Group1 Intervention

Primary Open Angle Glaucoma participants who meet inclusion exclusion criteria with central visual field loss will be randomly assigned a placebo, with no nutritional value, in capsule form.

Do I qualify?Apply below to find out

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for glaucoma primarily aim to reduce intraocular pressure (IOP) to prevent damage to the optic nerve. Medications such as prostaglandin analogs increase the outflow of aqueous humor, while beta-blockers and carbonic anhydrase inhibitors reduce its production. Neuroprotective strategies, like those being studied in GlaucoCetin, focus on supporting and protecting optic nerve cells from degeneration. This is crucial for glaucoma patients as preserving the health of optic nerve cells can slow disease progression and help maintain vision.

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Who is running the clinical trial?

Guardian Health Sciences, Inc.UNKNOWN

Wills EyeLead Sponsor

79 Previous Clinical Trials

10,336 Total Patients Enrolled

48 Trials studying Glaucoma

4,896 Patients Enrolled for Glaucoma

Natasha N Kolomeyer, MDPrincipal InvestigatorWills Eye Hospital

Media Library

GlaucoCetin (Dietary Supplement) Clinical Trial Eligibility Overview. Trial Name: NCT04784234 — N/A

Glaucoma Research Study Groups: GlaucoCetin Peripheral Group, Placebo Peripheral Group, GlaucoCetin Central Group, Placebo Central Group

Glaucoma Clinical Trial 2023: GlaucoCetin Highlights & Side Effects. Trial Name: NCT04784234 — N/A

GlaucoCetin (Dietary Supplement) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04784234 — N/A

~23 spots leftby Jun 2025

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