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

Official title

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

Overview

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.

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 outcome measures

• Change from baseline in visual function assessed by Mean Deviation (MD) at 12 months [Time frame: 12 months]
• Change from baseline in visual function assessed by Visual Field Index (VFI) at 12 months [Time frame: 12 months]

Secondary outcome measures (7)

• Rate of change (slope) in Visual Field Index (VFI) before, during, and after treatment [Time frame: Baseline, 6 months, 12 months, and 3 months post-treatment (15 months total)]
• Rate of change (slope) in Mean Deviation (MD) before, during, and after treatment [Time frame: Baseline, 6 months, 12 months, and 3 months post-treatment (15 months total).]
• Incidence of treatment-emergent adverse events during BrudyGlauco treatment [Time frame: 12 months]
• Change from baseline in Visual Field Index (VFI) at 6 months [Time frame: 6 months]
• Incidence of adverse events at 6 months [Time frame: 6 months]
• Change in Mean Deviation (MD) 3 months after treatment discontinuation [Time frame: 3 months post-treatment (15 months total).]
• Change in Visual Field Index (VFI) 3 months after treatment discontinuation [Time frame: 3 months post-treatment (15 months total).]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Double blind

Primary purpose

Treatment

Study locations

Spain · 2 centers

• Institut Català de Retina — Barcelona
• Hospital del Mar | Centre Esperança — Barcelona

Identifiers

NCT: NCT07322965 · ICR-02-24

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗