Vision Preservation and Restoration Following a 6 Month Trial of GlaucoCetin

Not Applicable

• Conditions: Primary Open Angle Glaucoma
• Interventions: Other: Placebo; Dietary Supplement: GlaucoCetin

• Registration Number: NCT04784234
• Lead Sponsor: Wills Eye

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.

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.

Study Timeline

• Study Start: 2021-02-01
• Study First Submitted: 2021-03-02
• Study First Submitted QC: 2021-03-04
• Study First Posted: 2021-03-05
• Status Verified: 2022-06
• Last Update Submitted: 2022-06-30
• Last Update Posted: 2022-07-05
• Primary Completion: 2023-02-28
• Study Completion: 2023-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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

• 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.
• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo Peripheral Group	Placebo	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.
GlaucoCetin Peripheral Group	GlaucoCetin	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.
GlaucoCetin Central Group	GlaucoCetin	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.
Placebo Central Group	Placebo	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.

Primary Outcome Measures

Name	Time	Method
Visual Field Mean Deviation	3 hour examinations during a 6 month period	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.

Secondary Outcome Measures

Name	Time	Method
Perceived Quality of Life Improvement	20 minute questionnaires during a 6 month period	Improvement in participants perceived vision-related quality of life (GQL-15, Glaucoma Symptom Scale (GSS)
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	Improvement in participants perceived vision-related quality of life ( National Eye Institute Visual Function Questionnaire 25 (NEI VFQ-25))

Trial Locations

Locations (1)

Wills Eye Hospital, Glaucoma Research Center; 🇺🇸 Philadelphia, Pennsylvania, United States