Evaluation of BRUDYGLAUCO (DHA + Citicoline) in Patients With Glaucoma
Evaluation of the Effect of BRUDYGLAUCO (DHA + Citicoline) in Patients With Glaucoma
Institut Catala de Retina
108 participants
Apr 1, 2025
INTERVENTIONAL
Conditions
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.
Eligibility
Inclusion Criteria5
- Patients with chronic glaucoma (primary or secondary, open-angle or closed-angle) diagnosed in at least one eye, meeting the following criteria:
- Structural damage: Thinning of the neuroretinal rim, peripapillary hemorrhage, or reduction in the nerve fiber layer, confirmed by OCT or color fundus photography.
- Functional damage: At least 3 contiguous abnormal points outside the 95% confidence limit in the pattern deviation map of the visual field.
- At least 4 reliable visual field (VF) tests before study enrollment.
- Age between 50 and 75 years.
Exclusion Criteria6
- Use of any vitamin or nutraceutical supplement in the month prior to screening.
- Any condition that could alter visual field testing, including:
- Neurological diseases. Retinal diseases. Advanced cataracts. Treatment with Lyrica (Pregabalin) due to its effect on visual fields.
- Hypersensitivity to acetylsalicylic acid (aspirin) (cross-reactivity risk with citicoline).
- Ocular surgery or laser treatment in the 3 months prior to enrollment or planned during the study.
- Mean Deviation (MD) of the visual field worse than -20 dB or better than -3 dB.
Interventions
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.
Locations(2)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT07322965