Recruiting

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

ClinicalTrials.gov IDNCT07322965

PhaseNA

Enrollment108

SponsorInstitut Catala de Retina

Age50 Years

SexALL

I'm interested View official listing

Conditions studied

Glaucoma, Primary Open Angle Glaucoma (POAG), Neuroprotection

About this study

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.

Interventions

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.

Primary outcomes

Change from baseline in visual function assessed by Mean Deviation (MD) at 12 months (12 months)
Change from baseline in visual function assessed by Visual Field Index (VFI) at 12 months (12 months)

Eligibility information

Inclusion Criteria: 1. 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. 2. At least 4 reliable visual field (VF) tests before study enrollment. 3. Age between 50 and 75 years. 4. If both eyes meet the inclusion criteria, the eye with the worst Mean Deviation (MD) will be selected as the study eye. Exclusion Criteria: 1. Use of any vitamin or nutraceutical supplement in the month prior to screening. 2. 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. 3. Hypersensitivity to acetylsalicylic acid (aspirin) (cross-reactivity risk with citicoline). 4. Ocular surgery or laser treatment in the 3 months prior to enrollment or planned during the study. 5. Mean Deviation (MD) of the visual field worse than -20 dB or better than -3 dB.

Study locations

Institut Català de Retina, Barcelona, Barcelona 08022 Spain
Hospital del Mar | Centre Esperança, Barcelona, Barcelona 08024 Spain

Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.

Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-09-27.