Actively Recruiting
Evaluation of the Effect of BRUDYGLAUCO (DHA + Citicoline) in Patients With Glaucoma
Led by Institut Catala de Retina · Updated on 2026-01-14
108
Participants Needed
2
Research Sites
4 weeks
Total Duration
On this page
Sponsors
I
Institut Catala de Retina
Lead Sponsor
H
Hospital de la Esperanza
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are investigating the potential neuroprotective effects of BrudyGlauco, a nutritional supplement containing docosahexaenoic acid (DHA) and citicoline, in people with glaucoma. Glaucoma causes progressive damage to the optic nerve, leading to vision loss, and current treatments mainly focus on lowering eye pressure. This study aims to see if BrudyGlauco can protect or improve visual function beyond existing therapies. Participants will be randomly assigned to receive either BrudyGlauco or a placebo containing sunflower oil. They will take two capsules orally at lunchtime each day for 12 months. The trial is double-blind and placebo-controlled, involving regular eye exams and visual field tests to measure changes in vision during and after treatment. An interim analysis will be done at 6 months to assess safety and early effects. During the study, participants will undergo ophthalmologic evaluations including visual field testing and measurement of DHA levels in blood samples using the Dry Blood Spot method. Researchers will monitor changes in visual function, treatment adherence, and safety. Follow-up will continue for 3 months after treatment ends to observe any lasting effects. The total participation duration is about 15 months, including treatment and post-treatment monitoring.
CONDITIONS
Brief Title
Evaluation of BRUDYGLAUCO (DHA + Citicoline) in Patients With Glaucoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients with chronic glaucoma (primary or secondary, open-angle or closed-angle) diagnosed in at least one eye
- Structural damage confirmed by OCT or color fundus photography (thinning of neuroretinal rim, peripapillary hemorrhage, or nerve fiber layer reduction)
- Functional damage shown by at least 3 contiguous abnormal points in the visual field pattern deviation map
- At least 4 reliable visual field tests before enrollment
- Age between 50 and 75 years
- If both eyes qualify, the eye with worse Mean Deviation will be selected as study eye
You will not qualify if you...
- Use of any vitamin or nutraceutical supplement in the month before screening
- Conditions that may affect visual field testing, including neurological diseases, retinal diseases, advanced cataracts, or treatment with Lyrica (Pregabalin)
- Hypersensitivity to acetylsalicylic acid (aspirin) due to cross-reactivity with citicoline
- Eye surgery or laser treatment in the 3 months before enrollment or planned during the study
- Visual field Mean Deviation worse than -20 dB or better than -3 dB
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 12 months
Participants take BrudyGlauco (DHA + Citicoline) or placebo capsules orally, two capsules at lunchtime daily for 12 months. Regular ophthalmologic evaluations including visual field tests and DHA biomarker analysis are performed to assess changes in visual function and treatment safety.
Visits at baseline, 6 months (interim analysis), and 12 months
Duration - 3 months
Participants are monitored for 3 months after treatment discontinuation to assess the persistence of any effects and visual function changes.
1 visit 3 months post-treatment
Trial Site Locations
Total: 2 locations
1
Institut Català de Retina
Barcelona, Barcelona, Spain, 08022
Actively Recruiting
2
Hospital del Mar | Centre Esperança
Barcelona, Barcelona, Spain, 08024
Not Yet Recruiting
Research Team
A
Alfonso Antón Lopez Antón Lopez, Prof MD PhD
E
Estela del Mar Sánchez Sotano, Biomedical science
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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