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

NCT07322965 | Recruiting

• 1 other identifier: ICR-02-24
• Study Type: interventional
• Target: 108
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Glaucoma; Primary Open Angle Glaucoma (POAG); Neuroprotection

Keywords

glaucoma; Primary Open-Angle Glaucoma (POAG); Neuroprotection; Visual Field; DHA (Docosahexaenoic Acid); Citicoline; Nutritional Supplement; Clinical Trial; Randomized Controlled Trial (RCT); Visual Function

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (7)

• 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

  Baseline, 6 months, 12 months, and 3 months post-treatment (15 months total).

• Incidence of treatment-emergent adverse events during BrudyGlauco treatment

  12 months

• Change from baseline in Visual Field Index (VFI) at 6 months

  6 months

• Incidence of adverse events at 6 months

  6 months

Study Arms (2)

BrudyGlauco

EXPERIMENTAL

Participants receive BrudyGlauco (DHA + Citicoline) orally, taking two capsules at lunchtime for 12 months.

Dietary Supplement: BrudyGlauco

Placebo Group

PLACEBO COMPARATOR

Participants receive placebo (sunflower oil capsules) orally, taking two capsules at lunchtime for 12 months.

Dietary Supplement: Placebo

Interventions

BrudyGlauco DIETARY_SUPPLEMENT

Participants in the experimental group will receive BrudyGlauco, a dietary supplement containing docosahexaenoic acid (DHA) and citicoline.

BrudyGlauco

Placebo DIETARY_SUPPLEMENT

Participants in the placebo comparator group will receive identical-looking capsules containing sunflower oil.

Placebo Group

Eligibility Criteria

• Age: 50 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hospital de la Esperanza: collaborator
• Institut Catala de Retina: lead

Study Sites (2)

Institut Català de Retina

Barcelona, Barcelona, 08022, Spain

RECRUITING

Hospital del Mar | Centre Esperança

Barcelona, Barcelona, 08024, Spain

NOT YET RECRUITING

MeSH Terms

Conditions

Glaucoma; Glaucoma, Open-Angle

Condition Hierarchy (Ancestors)

Ocular Hypertension; Eye Diseases

Central Study Contacts

Alfonso Antón Lopez Antón Lopez, Prof MD PhD

CONTACT

+34 93 4340553; alfonso.anton@icrcat.com

Estela del Mar Sánchez Sotano, Biomedical science

CONTACT

93 253 16 47; estela.sanchez@icrcat.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: This is a double-blind study in which both participants and investigators are masked to treatment. The placebo and BrudyGlauco capsules are identical in appearance and packaging to maintain blinding. The treatment assignment is known only to the unmasked study coordinator and the designated data manager responsible for randomization. Blinding will be maintained until the final analysis, except in cases where unblinding is necessary for patient safety.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is a randomized, double-blind, placebo-controlled, parallel-group study. Participants will be randomly assigned in a 1:1 ratio to receive either BrudyGlauco (DHA + Citicoline) or a placebo for 12 months. The study will evaluate changes in visual function, treatment safety, and adherence. The study design ensures that neither participants nor investigators know the assigned treatment group, minimizing bias

Study Record Dates

• First Submitted: March 25, 2025
• First Posted: January 7, 2026
• Study Start: April 1, 2025
• Primary Completion (Estimated): April 30, 2027
• Study Completion (Estimated): May 30, 2027
• Last Updated: January 14, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

ES (2)