BrudyGlauco (DHA and citicoline) for people with glaucoma

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

This trial will test whether taking BrudyGlauco (DHA plus citicoline) for 12 months helps preserve visual field in adults aged 50–75 with glaucoma.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 108 (estimated)
• Ages: 50 Years to 75 Years
• Sex: All
• Sponsor: Institut Catala de Retina (Academic / other)
• Locations: 2 sites (Barcelona, Barcelona and 1 other locations)
• Trial ID: NCT07322965 on ClinicalTrials.gov

What this trial studies

This is a randomized, double-blind, placebo-controlled, multicenter trial that gives participants either BrudyGlauco or a matching placebo for 12 months. The main outcome is change in visual field function, with additional monitoring of safety, tolerance, and treatment adherence. Investigators will collect DHA biomarkers using dry blood spot analysis and perform regular ophthalmologic exams and visual field testing, with an interim analysis at six months. Participants are recruited at ophthalmology centers in Barcelona and the study selects the eye with worse mean deviation when both eyes qualify.

Who should consider this trial

Good fit: Ideal candidates are adults 50–75 years old with chronic glaucoma and both structural and functional evidence of optic nerve damage who have at least four reliable prior visual field tests.

Not a fit: Patients outside the 50–75 age range, those who recently used vitamin or nutraceutical supplements, or those with neurological or retinal conditions, advanced cataract, or current pregabalin treatment are less likely to be eligible or to benefit from this intervention.

Why it matters

Potential benefit: If effective, BrudyGlauco could slow visual field loss by protecting the optic nerve, potentially preserving vision and quality of life.

How similar studies have performed: Some smaller clinical and observational studies have reported modest benefits from citicoline on visual function in glaucoma, while evidence for DHA alone is more limited and mixed.

Eligibility criteria

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.

Where this trial is running

Barcelona, Barcelona and 1 other locations

• Institut Català de Retina — Barcelona, Barcelona, Spain (Recruiting)
• Hospital del Mar | Centre Esperança — Barcelona, Barcelona, Spain (Not_yet_recruiting)

Study contacts

• Study coordinator: Alfonso Antón Lopez Antón Lopez, Prof MD PhD

Conditions Glaucoma; Primary Open Angle Glaucoma; Neuroprotection; glaucoma; Primary Open-Angle Glaucoma; Visual Field; DHA; Citicoline