Vision Preservation and Restoration Following a 6 Month Trial of GlaucoCetin

NCT04784234 | Terminated

• 1 other identifier: IRB #2020-145
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

This study is looking at changes in vision and visual function before and after a six month trial of a daily medical food called GlaucoCetin, formulated with ingredients to support and protect the optic nerve cells. Open angle glaucoma patients will be randomized to receive either a placebo or the medical food for 6 months. We hope to learn if this medical food can improve the vision of our glaucoma patients and to report the findings obtained to the general public.

Conditions

Primary Open Angle Glaucoma

Keywords

primary open angle glaucoma; visual field loss; vision enhancement; GlaucoCetin; Neuroprotection

Outcome Measures

Primary Outcomes (1)

• Visual Field Mean Deviation

  Improvement in visual field mean deviation, measured in decibels, will be compared before, during and after a 6 month trial of daily GlaucoCetin vs Placebo capsules.

  3 hour examinations during a 6 month period

Secondary Outcomes (2)

• Perceived Quality of Life Improvement

  20 minute questionnaires during a 6 month period

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

  20 minute questionnaires during a 6 month period

Study Arms (4)

GlaucoCetin Peripheral Group

ACTIVE COMPARATOR

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.

Dietary Supplement: GlaucoCetin

Placebo Peripheral Group

PLACEBO COMPARATOR

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.

Other: Placebo

GlaucoCetin Central Group

ACTIVE COMPARATOR

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.

Dietary Supplement: GlaucoCetin

Placebo Central Group

PLACEBO COMPARATOR

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.

Other: Placebo

Interventions

GlaucoCetin DIETARY_SUPPLEMENT

GlaucoCetin, a medical food in capsule form, is FDA regulated and includes ingredients that have been shown to support and protect mitochondrial function of retinal ganglion cells. GlaucoCetin consists of a mixture of Curcumin, N-Acetyl Cysteine, Ginkgo Biloba Extract, Alpha-lipoic Acid, Citicoline, Grape Seed Extract, Green Tea Extract, and Coenzyme Q10. Additional ingredients include L-Taurine, Niacinamide, Biotin, Natural Astaxanthin, Fisetin, Quercetin, Luteolin, Proprietary Dragonberry Flavor Complex, Monk Fruit, Bitter Blocker Natural Flavor, Citric Acid, Silica Dioxide, Fibersol-2, L-Leucine. Many of these are known anti-inflammatory and antioxidant ingredients. A 6 month supply of capsules, made for this study, will be provided at randomization with the following instructions: Take 6 capsules by mouth once daily with food.

GlaucoCetin Central Group; GlaucoCetin Peripheral Group

Placebo OTHER

The placebo is an identical capsule to the GlaucoCetin, made for this study, with no nutritional value. A 6 month supply of capsules will be provided at randomization with the following instructions: Take 6 capsules by mouth once daily with food.

Placebo Central Group; Placebo Peripheral Group

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age of 40 to 80 years
• Bilateral open angle glaucoma with reliable visual field defects (at least one eye with mean deviation (MD) between -4.00 to -10.00 decibels (dB) on Humphrey Visual Field 24-2.
• Group 1 (Peripheral): meets 1 hodapp-parrish-anderson (HPA) criteria for defect (3 contiguous points depressed on the pattern standard deviation (PSD) p \<5%, one of which is depressed at p \<1% level), and does not meet below paracentral criteria for Group 2.
• Group 2 (Central): at least 1 paracentral point repeatedly depressed at p\<1% on 24-2. Also meets the HAP criteria outlined above.
• Visual acuity 20/40 or better in each eye
• Intraocular Pressure (IOP) controlled at 2 measurements \>3 months
• Clear media

You may not qualify if:

• Known bleeding disorder
• History of epilepsy or on anti-seizure medication
• Uncontrolled hypertension or diabetes
• Uncontrolled IOP
• Eye pathology leading to inaccurate IOP measurement
• Visually significant retinal pathology affecting vision in past or active (such as diabetic retinopathy or age related macular degeneration)
• Non-glaucomatous optic neuropathy
• Visually significant cataract (worse then 2+ cataract, or what is determined visually clinically significant by physician)
• History of ocular trauma
• Selective laser trabeculoplasty or laser procedure within past 3 months
• Cataract surgery within past 3 months
• Incisional glaucoma surgery within 6 months
• Current use of nitroglycerin
• Current use of antiplatelet therapy besides aspirin (such as clopidogrel) or anticoagulation (such as warfarin)
• Current use of systemic steroids or immunomodulating agents such as methotrexate.

Sponsors & Collaborators

• Wills Eye: lead
• Guardian Health Sciences, Inc.: collaborator

Study Sites (1)

Wills Eye Hospital, Glaucoma Research Center

Philadelphia, Pennsylvania, 19107, United States

Location

MeSH Terms

Conditions

Glaucoma, Open-Angle

Condition Hierarchy (Ancestors)

Glaucoma; Ocular Hypertension; Eye Diseases

Study Officials

• Natasha N Kolomeyer, MD

  Wills Eye Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Masking of GlaucoCetin and identical Placebo was provided by Guardian Health Sciences, Inc. Labeling has been conducted by non-clinical study team personnel in Glaucoma Research Center at Wills Eye Hospital.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Study aims to enroll 50 patients within each intervention arm (GlaucoCetin vs Placebo). Within the intervention arm there will be one group with Central visual field defects and one group with Peripheral visual field defects.

Study Record Dates

• First Submitted: March 2, 2021
• First Posted: March 5, 2021
• Study Start: February 1, 2021
• Primary Completion: October 27, 2022
• Study Completion: October 27, 2022
• Last Updated: December 23, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)