NCT07322965

Evaluation of BRUDYGLAUCO (DHA + Citicoline) in Patients With Glaucoma

Evaluation of the Effect of BRUDYGLAUCO (DHA + Citicoline) in Patients With Glaucoma

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 108 (estimated)
• Sponsor: Institut Catala de Retina · Academic / Other
• Sex: All
• Age: 50 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Glaucoma
• Primary Open Angle Glaucoma (POAG)
• Neuroprotection

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	BrudyGlauco	Participants in the experimental group will receive BrudyGlauco, a dietary supplement containing docosahexaenoic acid (DHA) and citicoline.
DIETARY_SUPPLEMENT	Placebo	Participants in the placebo comparator group will receive identical-looking capsules containing sunflower oil.

Timeline

• Start date: 2025-04-01
• Primary completion: 2027-04-30
• Completion: 2027-05-30
• First posted: 2026-01-07
• Last updated: 2026-01-14

Locations

2 sites across 1 country: Spain