Evaluation of BRUDYGLAUCO (DHA + Citicoline) in Patients With Glaucoma
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age50-75
SponsorInstitut Catala de Retina
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
Use of any vitamin or nutraceutical supplement in the month prior to screening.
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.
Trial design
Design model
Parallel
Treatments tested in this trial
BrudyGlauco
Dietary supplementParticipants in the experimental group will receive BrudyGlauco, a dietary supplement containing docosahexaenoic acid (DHA) and citicoline.
Placebo
Dietary supplementParticipants in the placebo comparator group will receive identical-looking capsules containing sunflower oil.
Treatment groups
108 Participants
are divided into 2 treatment groupsGroup A: BrudyGlaucoExperimental treatment 1 intervention
Group B: Placebo GroupPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
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
Time frame
12 months2
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
Time frame
12 monthsSecondary outcomes
1
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
Time frame
Baseline, 6 months, 12 months, and 3 months post-treatment (15 months total)2
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
Time frame
Baseline, 6 months, 12 months, and 3 months post-treatment (15 months total).3
Incidence of treatment-emergent adverse events during BrudyGlauco treatment
Incidence of treatment-emergent adverse events during BrudyGlauco treatment
Time frame
12 months4
Change from baseline in Visual Field Index (VFI) at 6 months
Change from baseline in Visual Field Index (VFI) at 6 months
Time frame
6 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Institut Catala de Retina
Lead sponsor
Hospital de la Esperanza
Collaborator
Source ClinicalTrials.gov