GlaucomaBRUDYGLAUCONCT07322965
Evaluation of BRUDYGLAUCO (DHA + Citicoline) in Patients With Glaucoma
A study testing BrudyGlauco in people with Glaucoma and Primary Open Angle Glaucoma (POAG), run by Institut Catala de Retina at 2 sites in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 to 75 years
- Conditions the study is for
- Glaucoma, Primary Open Angle Glaucoma (POAG), Neuroprotection
- What is being tested?
- BrudyGlauco
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 108 participants
- Where
- 2 sitesSpain
- Study dates
- 1 Apr 2025to 30 May 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Alfonso Antón Lopez Antón Lopez, Prof MD PhD contact
Spain2 sites, 2 recruiting
- Recruiting
Institut Català de Retina
Barcelona, Barcelona, 08022
Estela del Mar Sánchez Sotano, 662397315, estelasanchezs37@gmail.com
- Not yet recruiting
Hospital del Mar | Centre Esperança
Barcelona, Barcelona, 08024
CRISTINA BLASCO, 662397315, estelasanchezs37@gmail.com
About this study
Official title: 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.
Read more
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.
Read the 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.
- Being tested
- BrudyGlauco, Placebo
- Keywords
- glaucoma, Primary Open-Angle Glaucoma (POAG), Neuroprotection, Visual Field, DHA (Docosahexaenoic Acid), Citicoline, Nutritional Supplement, Clinical Trial, Randomized Controlled Trial (RCT), Visual Function
- Medical subject headings
- Glaucoma, Glaucoma, Open-Angle
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BrudyGlaucoDietary supplement
Participants in the experimental group will receive BrudyGlauco, a dietary supplement containing docosahexaenoic acid (DHA) and citicoline.
PlaceboDietary supplement
Participants in the placebo comparator group will receive identical-looking capsules containing sunflower oil.
| Study group | Role | What they receive |
|---|---|---|
| BrudyGlauco | Experimental | Participants receive BrudyGlauco (DHA + Citicoline) orally, taking two capsules at lunchtime for 12 months. Receives: Dietary Supplement: BrudyGlauco |
| Placebo Group | Placebo comparator | Participants receive placebo (sunflower oil capsules) orally, taking two capsules at lunchtime for 12 months. Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 12 months
Secondary outcomes (7)
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
Measured: 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
Measured: Baseline, 6 months, 12 months, and 3 months post-treatment (15 months total).
Incidence of treatment-emergent adverse events during BrudyGlauco treatment
Incidence of treatment-emergent adverse events during BrudyGlauco treatment
Measured: 12 months
Change from baseline in Visual Field Index (VFI) at 6 months
Change from baseline in Visual Field Index (VFI) at 6 months
Measured: 6 months
Incidence of adverse events at 6 months
Incidence of adverse events at 6 months
Measured: 6 months
Change in Mean Deviation (MD) 3 months after treatment discontinuation
Change in Mean Deviation (MD) 3 months after treatment discontinuation
Measured: 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
Measured: 3 months post-treatment (15 months total).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2026
- Study start1 Apr 2025
- Primary completion30 Apr 2027 (estimated)
- Study completion30 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GlaucomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 108 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institut Catala de Retina
- Sponsor type
- University, hospital or other
- Collaborators
- Hospital de la Esperanza
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07322965
- Sponsor's protocol ID
- ICR-02-24
- Acronym
- BRUDYGLAUCO
- Status last verified
- Jan 2026
- First submitted
- 25 Mar 2025
- Last updated
- 14 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effect of BRUDYGLAUCO (DHA + Citicoline) in Patients With Glaucoma
- ClinicalTrials.gov ID
- NCT07322965
- Acronym / sponsor ID
- BRUDYGLAUCO / ICR-02-24
- Keywords
- glaucoma, Primary Open-Angle Glaucoma (POAG), Neuroprotection, Visual Field, DHA (Docosahexaenoic Acid), Citicoline, Nutritional Supplement, Clinical Trial
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 108 participants (estimated)
- Lead sponsor
- Institut Catala de RetinaUniversity, hospital or other
- Collaborators
- Hospital de la Esperanza
- Study start
- 1 Apr 2025 (actual)
- Primary completion
- 30 Apr 2027 (estimated)
- Study completion
- 30 May 2027 (estimated)
- First posted
- 7 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- 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
| Arm | Type | Receives |
|---|---|---|
| BrudyGlauco | Experimental | Dietary Supplement: BrudyGlaucoParticipants receive BrudyGlauco (DHA + Citicoline) orally, taking two capsules at lunchtime for 12 months. |
| Placebo Group | Placebo comparator | Dietary Supplement: PlaceboParticipants receive placebo (sunflower oil capsules) orally, taking two capsules at lunchtime for 12 months. |
Who may qualify
- Ages
- 50 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BrudyGlaucoParticipants in the experimental group will receive BrudyGlauco, a dietary supplement containing docosahexaenoic acid (DHA) and citicoline. | Dietary supplement | BrudyGlauco |
| PlaceboParticipants in the placebo comparator group will receive identical-looking capsules containing sunflower oil. | Dietary supplement | Placebo Group |
Primary outcome
Change from baseline in visual function assessed by Mean Deviation (MD) at 12 months
Time frame: 12 months
Change from baseline in visual function assessed by Mean Deviation (MD) at 12 months
Change from baseline in visual function assessed by Visual Field Index (VFI) at 12 months
Time frame: 12 months
Change from baseline in visual function assessed by Visual Field Index (VFI) at 12 months
7 secondary outcomes
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)
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).
Incidence of treatment-emergent adverse events during BrudyGlauco treatment
Time frame: 12 months
Change from baseline in Visual Field Index (VFI) at 6 months
Time frame: 6 months
Incidence of adverse events at 6 months
Time frame: 6 months
Change in Mean Deviation (MD) 3 months after treatment discontinuation
Time frame: 3 months post-treatment (15 months total).
Change in Visual Field Index (VFI) 3 months after treatment discontinuation
Time frame: 3 months post-treatment (15 months total).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Alfonso Antón Lopez Antón Lopez, Prof MD PhD contact
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing BrudyGlauco in people with Glaucoma and Primary Open Angle Glaucoma (POAG), run by Institut Catala de Retina at 2 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 14 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Alfonso Antón Lopez Antón Lopez, Prof MD PhD (+34 93 4340553 ext. 4002, alfonso.anton@icrcat.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in visual function assessed by Mean Deviation (MD) at 12 months (time frame: 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jan 2026.