This study aims to evaluate the effects of BrudyGlauco, a nutritional supplement containing DHA (docosahexaenoic acid) and citicoline, on visual function in people with glaucoma. Glaucoma is a progressive optic neuropathy that can lead to vision loss. Current treatments focus on lowering eye pressure, but there are other pathogenic factors and the use of additional therapies that could protect or regenerate the optic nerve would be beneficial. This is a randomized, double-blind, placebo-controlled, and multicenter clinical trial. Participants will be randomly assigned to receive either BrudyGlauco or a placebo for 12 months. The study will assess changes in visual field, safety, and treatment adherence. The trial is being conducted at the Institut Català de Retina (ICR) and Hospital de la Esperanza. Participants will undergo regular eye exams, visual field tests, and follow-ups to monitor potential improvements in visual function. The results of this study will help determine if BrudyGlauco can provide neuroprotective benefits for people with glaucoma and improve their quality of life.
This study investigates the potential neuroprotective or neuromodulatory effects of BrudyGlauco, a nutritional supplement containing docosahexaenoic acid (DHA) and citicoline, in patients with glaucoma. Glaucoma is a progressive optic neuropathy that leads to visual field deterioration and, in severe cases, to blindness. Although current treatments primarily target intraocular pressure (IOP), the progression of vision loss in glaucoma could benefit by therapies aimed at protecting the optic nerve. This randomized, double-blind, placebo-controlled trial will assess the effects of BrudyGlauco on visual function over 12 months, with the primary outcome focusing on changes in visual field function. Secondary outcomes include treatment safety, tolerance, and the persistence of any observed effects after treatment discontinuation. Participants will be recruited from Institut Català de Retina (ICR) and Hospital de la Esperanza, where they will undergo regular ophthalmologic evaluations. These evaluations include visual field tests to measure any changes in vision and DHA biomarker analysis using the Dry Blood Spot (DBS) method to assess DHA levels in erythrocyte membranes. An interim analysis at six months will allow for an early assessment of efficacy and safety. The final results will determine whether BrudyGlauco has neuroprotective potential for glaucoma management, offering insights into its ability to protect the optic nerve and potentially improve quality of life for patients living with the disease. Glaucoma is one of the leading causes of blindness worldwide, and current treatments that focus on lowering IOP are not always sufficient to prevent the progressive loss of vision. This study will explore whether DHA and citicoline, known for their neuroprotective properties, can offer additional benefits beyond traditional treatments.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
108
Participants in the experimental group will receive BrudyGlauco, a dietary supplement containing docosahexaenoic acid (DHA) and citicoline.
Participants in the placebo comparator group will receive identical-looking capsules containing sunflower oil.
Institut Català de Retina
Barcelona, Barcelona, Spain
RECRUITINGHospital del Mar | Centre Esperança
Barcelona, Barcelona, Spain
NOT_YET_RECRUITINGChange from baseline in visual function assessed by Mean Deviation (MD) at 12 months
Change from baseline in visual function assessed by Mean Deviation (MD) at 12 months
Time frame: 12 months
Change from baseline in visual function assessed by Visual Field Index (VFI) at 12 months
Change from baseline in visual function assessed by Visual Field Index (VFI) at 12 months
Time frame: 12 months
Rate of change (slope) in Visual Field Index (VFI) before, during, and after treatment
Rate of change (slope) in Visual Field Index (VFI) before, during, and after treatment
Time frame: Baseline, 6 months, 12 months, and 3 months post-treatment (15 months total)
Rate of change (slope) in Mean Deviation (MD) before, during, and after treatment
Rate of change (slope) in Mean Deviation (MD) before, during, and after treatment
Time frame: Baseline, 6 months, 12 months, and 3 months post-treatment (15 months total).
Incidence of treatment-emergent adverse events during BrudyGlauco treatment
Incidence of treatment-emergent adverse events during BrudyGlauco treatment
Time frame: 12 months
Change from baseline in Visual Field Index (VFI) at 6 months
Change from baseline in Visual Field Index (VFI) at 6 months
Time frame: 6 months
Incidence of adverse events at 6 months
Incidence of adverse events at 6 months
Time frame: 6 months
Change in Mean Deviation (MD) 3 months after treatment discontinuation
Change in Mean Deviation (MD) 3 months after treatment discontinuation
Time frame: 3 months post-treatment (15 months total).
Change in Visual Field Index (VFI) 3 months after treatment discontinuation
Change in Visual Field Index (VFI) 3 months after treatment discontinuation
Time frame: 3 months post-treatment (15 months total).
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