Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:24 AM
Ignite Modification Date:
2025-12-25 @ 2:24 AM
NCT ID:
NCT04784234
Eligibility Criteria:
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
40 Years
Maximum Age:
80 Years
Study:
NCT04784234
Study Brief:
Protocol Section:
NCT04784234