Evaluation of BRUDYGLAUCO (DHA + Citicoline) in Patients With Glaucoma
Recruiting · NCT07322965 · Interventional (participants receive a specific treatment) · Lead sponsor: Institut Catala de Retina
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
Inclusion criteria
- 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.
- If both eyes meet the inclusion criteria, the eye with the worst Mean Deviation (MD) will be selected as the study eye.
Exclusion criteria
- 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.
Where it is running
2 locations listed.
- Institut Català de Retina - Barcelona, Barcelona, Spain
- Hospital del Mar | Centre Esperança - Barcelona, Barcelona, Spain