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

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Dietary supplement
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 50
Maximum Age: 75
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Spain
Hospital del Mar | Centre Esperança
NOT_YET_RECRUITING
Barcelona
Institut Català de Retina
RECRUITING
Barcelona
Contact Information
Primary
Alfonso Antón Lopez Antón Lopez, Prof MD PhD
alfonso.anton@icrcat.com
+34 93 4340553
Backup
Estela del Mar Sánchez Sotano, Biomedical science
estela.sanchez@icrcat.com
93 253 16 47
Time Frame
Start Date: 2025-04-01
Estimated Completion Date: 2027-05-30
Participants
Target number of participants: 108
Treatments
Experimental: BrudyGlauco
Participants receive BrudyGlauco (DHA + Citicoline) orally, taking two capsules at lunchtime for 12 months.
Placebo_comparator: Placebo Group
Participants receive placebo (sunflower oil capsules) orally, taking two capsules at lunchtime for 12 months.
Sponsors
Collaborators: Hospital de la Esperanza
Leads: Institut Catala de Retina

This content was sourced from clinicaltrials.gov