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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Glaucoma; Primary Open Angle Glaucoma (POAG); Neuroprotection
• Intervention / Treatment: Dietary supplement: BrudyGlauco; Dietary supplement: Placebo

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.

• Study Type: Interventional
• Enrollment (Estimated): 108
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Alfonso Antón Lopez Antón Lopez, Prof MD PhD; Phone Number: 4002 +34 93 4340553; Email: alfonso.anton@icrcat.com
• Study Contact Backup: Name: Estela del Mar Sánchez Sotano, Biomedical science; Phone Number: 93 253 16 47; Email: estela.sanchez@icrcat.com

Study Locations

• Spain
  • Barcelona
    • Barcelona, Barcelona, Spain, 08022
      • Recruiting
      • Institut Català de Retina
      • Contact: Estela del Mar Sánchez Sotano; Phone Number: 662397315; Email: estelasanchezs37@gmail.com
    • Barcelona, Barcelona, Spain, 08024
      • Not yet recruiting
      • Hospital del Mar | Centre Esperança
      • Contact: CRISTINA BLASCO; Phone Number: 662397315; Email: estelasanchezs37@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: BrudyGlauco; Participants receive BrudyGlauco (DHA + Citicoline) orally, taking two capsules at lunchtime for 12 months.	Dietary supplement: BrudyGlauco; Participants in the experimental group will receive BrudyGlauco, a dietary supplement containing docosahexaenoic acid (DHA) and citicoline.
Placebo Comparator: Placebo Group; Participants receive placebo (sunflower oil capsules) orally, taking two capsules at lunchtime for 12 months.	Dietary supplement: Placebo; Participants in the placebo comparator group will receive identical-looking capsules containing sunflower oil.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Institut Catala de Retina
• Collaborators: Hospital de la Esperanza

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2025
• Primary Completion (Estimated): April 30, 2027
• Study Completion (Estimated): May 30, 2027

Study Registration Dates

• First Submitted: March 25, 2025
• First Submitted That Met QC Criteria: December 23, 2025
• First Posted (Estimated): January 7, 2026

Study Record Updates

• Last Update Posted (Actual): January 14, 2026
• Last Update Submitted That Met QC Criteria: January 12, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: Clinical Trial; Neuroprotection; glaucoma; Nutritional Supplement; Citicoline; Randomized Controlled Trial (RCT); Visual Field; Primary Open-Angle Glaucoma (POAG); Visual Function; DHA (Docosahexaenoic Acid)
• Additional Relevant MeSH Terms: Eye Diseases; Ocular Hypertension; Glaucoma; Glaucoma, Open-Angle
• Other Study ID Numbers: ICR-02-24

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No