Vision Preservation and Restoration Following a 6 Month Trial of GlaucoCetin

Last updated: June 30, 2022
Sponsor: Wills Eye
Overall Status: Active - Recruiting

Phase

N/A

Condition

Glaucoma

Open Angle Glaucoma

Treatment

N/A

Clinical Study ID

NCT04784234
IRB #2020-145
  • Ages 40-80
  • All Genders

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Age of 40 to 80 years
  • Bilateral open angle glaucoma with reliable visual field defects (at least one eyewith mean deviation (MD) between -4.00 to -10.00 decibels (dB) on Humphrey VisualField 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%, oneof which is depressed at p <1% level), and does not meet below paracentralcriteria 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

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 asdiabetic retinopathy or age related macular degeneration)
  • Non-glaucomatous optic neuropathy
  • Visually significant cataract (worse then 2+ cataract, or what is determined visuallyclinically 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) oranticoagulation (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 SeedExtract, Green Tea Leaf Extract, Coenzyme Q10, Biotin, Natural Astaxanthin, flavonoidcomplex containing Fisetin, Quercetin, and Luteolin
  • Recent change in systemic medications or vitamins
  • Use of Biotin, Ginkgo Biloba, Citicoline within past 3 months (or any otherGlaucocetin ingredients within 1 month)
  • Unreliable visual fields
  • Unwilling to take supplement or placebo for 6 months

Study Design

Total Participants: 100
Study Start date:
February 01, 2021
Estimated Completion Date:
December 31, 2023

Study 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.

Connect with a study center

  • Wills Eye Hospital, Glaucoma Research Center

    Philadelphia, Pennsylvania 19107
    United States

    Active - Recruiting

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