ClinicalTrials.gg
TerminatedNCT04784234Updated Dec 23, 2025

Vision Preservation and Restoration Following a 6 Month Trial of GlaucoCetin

An interventional study of GlaucoCetin and Placebo in Primary Open Angle Glaucoma, sponsored by Wills Eye. Terminated at 1 site in United States. Open to participants aged 40 Years to 80 Years. Per ClinicalTrials.gov, last updated 2025-12-23.

Sponsored by Wills Eye · Not applicable, Interventional, and Treatment

Why this study was terminated
company was bought and discontinued producing supplement
Phase
Not applicable
Study type
Interventional
Enrollment
12
Allocation
Randomized
Ages
40 Years to 80 Years
Sex
All
01

Study 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.

Read the detailed description

The primary objective of this study is to evaluate the improvement in vision and visual function during a 6 month trial of GlaucoCetin versus placebo in patients with open angle glaucoma. The secondary objective is to evaluate change in quality of life, electrophysiologic response, and contrast sensitivity.

Procedures involved during participation include review of medical/ocular history, best corrected visual acuity, multiple Humphrey visual field testing 24-2 and 10-2 , Octopus G-Top, pattern electroretinogram (PERG), ocular coherence tomography (OCT), ocular coherence tomography angiography (OCTA), intraocular pressure (IOP), contrast sensitivity testing (CSV-1000), corneal hysteresis, biomicroscopy, fundus exam, disc photos, and serum testing.

To evaluate quality of life, included in testing is Compressed Assessment of Ability Related to Vision (CAARV). Responses to multiple surveys regarding vision related quality of life (GQL-15, Glaucoma Symptom Scale (GSS), National Eye Institute Visual Function Questionnaire 25 (NEI VFQ-25)) and diet (NHANES Dietary Screener) will be captured. Number of daily steps will be monitored at 2 intervals during the study using pedometers.

02

Conditions studied

  • Primary Open Angle Glaucoma

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Keywords

  • primary open angle glaucoma
  • visual field loss
  • vision enhancement
  • GlaucoCetin
  • Neuroprotection
03

In context

Glaucoma, Open-Angle

924 studies on the registry are indexed under Glaucoma, Open-Angle; 117 are open to participants now.

This study's enrollment of 12 is below the median of 80 across 692 interventional studies indexed under Glaucoma, Open-Angle.

Browse Glaucoma, Open-Angle studies →

Lead sponsor

Wills Eye is the lead sponsor of 77 studies on the registry; 2 are open to participants now.

Of its 12 completed or terminated interventional studies of FDA-regulated products, 10 (83%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
40 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • 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 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 or immunomodulating agents such as methotrexate.
  • Sensitivity or allergy to any ingredients in GlaucoCetin: Curcumin, L-Taurine, N-Acetyl Cysteine, Niacinamide, Ginkgo Biloba, Lipoic Acid, Citicoline, Grape Seed Extract, Green Tea Leaf Extract, Coenzyme Q10, Biotin, Natural Astaxanthin, flavonoid complex containing Fisetin, Quercetin, and Luteolin
  • Recent change in systemic medications or vitamins
  • Use of Biotin, Ginkgo Biloba, Citicoline within past 3 months (or any other Glaucocetin ingredients within 1 month)
  • Unreliable visual fields
  • Unwilling to take supplement or placebo for 6 months
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
12 participants (actual)

Study arms

  • Active comparator
    GlaucoCetin Peripheral Group

    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 comparator
    Placebo Peripheral Group

    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

  • Active comparator
    GlaucoCetin Central Group

    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 comparator
    Placebo Central Group

    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

  • Dietary supplementGlaucoCetin

    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.

  • OtherPlacebo

    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.

06

What researchers measure

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.

    Time frame: 3 hour examinations during a 6 month period

Secondary outcomes

  1. Perceived Quality of Life Improvement

    Improvement in participants perceived vision-related quality of life (GQL-15, Glaucoma Symptom Scale (GSS)

    Time frame: 20 minute questionnaires during a 6 month period

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

    Improvement in participants perceived vision-related quality of life ( National Eye Institute Visual Function Questionnaire 25 (NEI VFQ-25))

    Time frame: 20 minute questionnaires during a 6 month period

07

Study locations

1 site
  • Wills Eye Hospital, Glaucoma Research Center
    Philadelphia, Pennsylvania 19107, United States
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Feb 2021 to primary completion in Oct 2022, 20 months.

How these figures are worked out, and which studies are left out of them.

Registered
Mar 2, 2021
First posted
Mar 5, 2021
StartActual
Feb 1, 2021
Primary completionActual
Oct 27, 2022
CompletionActual
Oct 27, 2022
Last update
Dec 23, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Dec 23, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04784234
Lead sponsor
Wills Eye
Collaborators
Guardian Health Sciences, Inc.
Responsible party
Natasha Nayak Kolomeyer, MD (Principal Investigator, Wills Eye) — Principal investigator
First posted
Mar 5, 2021
Start date
Feb 1, 2021
Primary completion
Oct 27, 2022
Completion
Oct 27, 2022
Last update
Dec 23, 2025

Study contacts

Natasha N Kolomeyer, MD
principal investigator · Wills Eye Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is terminated, as verified in Dec 2025. You cannot join it, but the record below documents what was studied.

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