GlaucomaNCT05527106
Evaluation of the Effect of Citicoline and Docosahexaenoic Acid (DHA) on the Visual Function of Patients With Glaucoma
A study testing Citicoline, Docosahexaenoic Acid (DHA) and Citicoline and Docosahexaenoic Acid (DHA) in people with Glaucoma, run by Institut Catala de Retina at 1 site in Spain.
Trial summary
Pilot, single-blind, randomized and controlled study to evaluate the changes produced in the visual function of patients with glaucoma after oral administration for 3 months of citicoline and docosahexaenoic Acid (DHA) vs citicoline and docosahexaenoic Acid (DHA) vs vitamin C. Read more about this study
- Who is it for?
- Ages 50 to 75 years
- Conditions the study is for
- Glaucoma
- What is being tested?
- Citicoline, Docosahexaenoic Acid (DHA) and Citicoline and Docosahexaenoic Acid (DHA)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 73 participants
- Where
- 1 siteSpain
- Study dates
- 12 Mar 2015to 25 May 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
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, primary or secondary, open or closed angle glaucoma, diagnosed by meeting the following criteria:
- Signs of structural damage: thinning of the optical nerve or peripapillary hemorrhage or decrease in the nerve fiber layer that can be seen by OCT.
- Signs of functional damage: 3 points outside 95% of the normal limit on the visual field pattern deviation graph.
- There must be at least 3 reliable visual fields prior to the start of the study.
- Patients between 50 and 75 years old, homogeneously distributed among the groups.
- Glaucoma with functional and structural damage.
- Medium grade, Mean Deviation (MD) between -4 and -20 dB.
- In at least one eye.
Who cannot join
- Treatment with some other vitamin or nutraceutical preparation.
- Any pathology that can alter the visual field. (Neurological diseases, retinopathies, advanced cataract, patients treated with lyrica (due to the affectation it produces in the visual field)).
- Hypersensitivity to aspirin. (Cross-allergic reaction has been reported in patients taking citicoline.)
- Allergic to fish protein.
- Eye surgery in the 3 months before or during the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the Effect of Citicoline (Cebrolux 800 mg) and Docosahexaenoic Acid (DHA) Compound (BrudyPio 1.5 g) on the Visual Function of Patients With Glaucoma With a Pilot Study
Pilot, single-blind, randomized and controlled study to evaluate the changes produced in the visual function of patients with glaucoma after oral administration for 3 months of citicoline and docosahexaenoic Acid (DHA) vs citicoline and docosahexaenoic Acid (DHA) vs vitamin C.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CiticolineDietary supplement
Also called Cebrolux 800
Every subject randomized into this group have to take 2 sachets of Cebrolux 800 (362 mg of citicoline per day), every day, for 3 months.
Docosahexaenoic Acid (DHA)Dietary supplement
Also called Brudypio 1.5g
Every subject randomized into this group have to take 3 pills of Brudypio 1.5g (1050 mg of DHA per day), every day, for 3 months.
Citicoline and Docosahexaenoic Acid (DHA)Dietary supplement
Every subject randomized into this group have to take 2 sachets of Cebrolux 800 and 3 pills of Brudypio 1.5g per day, every day, for 3 months.
Vitamin CDietary supplement
Also called L-ascorbic acid
Every subject randomized into this group have to take 1 pills of Vitamin C (500 mg per day), every day, for 3 months.
| Study group | Role | What they receive |
|---|---|---|
| Citicoline | Experimental | Cebrolux 800 is a food supplement based on citicoline (163 mg) that also contains vitamin A, E, C and B6. Receives: Dietary Supplement: Citicoline |
| Docosahexaenoic Acid (DHA) | Experimental | Brudypio 1.5g is a food supplement based on Omega-3 fatty acid in the form of triglycerides (DHA 70% [350 mg], EPA 8.5%, DPA 6%) that also contains vitamins (A, B1, B2, B3, B6, B9, B12, C, E), carotenoids ( lutein, zeaxanthin, lycopene), glutathione, coenzyme Q10 and minerals (Zn, Se, Cu, Mn). Receives: Dietary Supplement: Docosahexaenoic Acid (DHA) |
| Citicoline and Docosahexaenoic Acid (DHA) | Experimental | Cebrolux 800 and Brudypio 1.5g (see above). Receives: Dietary Supplement: Citicoline and Docosahexaenoic Acid (DHA) |
| Vitamin C | Experimental | Vitamin C. Receives: Dietary Supplement: Vitamin C |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effect on Mean Defect (MD)
Evaluation of changes on the MD (decibels) with study treatment.
Measured: From Baseline to Month 3.
Effect on Visual Field Index (VFI)
Evaluation of changes on the VFI (%) with study treatment.
Measured: From Baseline to Month 3.
Secondary outcomes (2)
Evaluation of the changes produced in the intraocular pressure (IOP)
To compare IOP (mmHg) measurements with study treatment.
Measured: From Baseline to Month 3.
Evaluation of tolerance
Describe the tolerance and the adverse events with study treatment.
Measured: From Month 1 to Month 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2022
- Study start12 Mar 2015
- Primary completion25 May 2022
- Study completion25 May 2022
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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 73 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institut Catala de Retina
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Alfonso Anton, MD, PhD, Principal investigator, Institut Catala de Retina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05527106
- Sponsor's protocol ID
- ICR-14/13
- Status last verified
- Sep 2022
- First submitted
- 29 Aug 2022
- Last updated
- 2 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effect of Citicoline (Cebrolux 800 mg) and Docosahexaenoic Acid (DHA) Compound (BrudyPio 1.5 g) on the Visual Function of Patients With Glaucoma With a Pilot Study
- ClinicalTrials.gov ID
- NCT05527106
- Acronym / sponsor ID
- ICR-14/13
- Conditions
- Glaucoma
- Keywords
- glaucoma, nutraceuticals, dha (docosahexaenoic acid), citicoline
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 73 participants (actual)
- Lead sponsor
- Institut Catala de RetinaUniversity, hospital or other
- Study start
- 12 Mar 2015 (actual)
- Primary completion
- 25 May 2022 (actual)
- Study completion
- 25 May 2022 (actual)
- First posted
- 2 Sep 2022 (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.
Pilot, single-blind, randomized and controlled study to evaluate the changes produced in the visual function of patients with glaucoma after oral administration for 3 months of citicoline and docosahexaenoic Acid (DHA) vs citicoline and docosahexaenoic Acid (DHA) vs vitamin C.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Citicoline | Experimental | Dietary Supplement: CiticolineCebrolux 800 is a food supplement based on citicoline (163 mg) that also contains vitamin A, E, C and B6. |
| Docosahexaenoic Acid (DHA) | Experimental | Dietary Supplement: Docosahexaenoic Acid (DHA)Brudypio 1.5g is a food supplement based on Omega-3 fatty acid in the form of triglycerides (DHA 70% [350 mg], EPA 8.5%, DPA 6%) that also contains vitamins (A, B1, B2, B3, B6, B9, B12, C, E), carotenoids ( lutein, zeaxanthin, lycopene), glutathione, coenzyme Q10 and minerals (Zn, Se, Cu, Mn). |
| Citicoline and Docosahexaenoic Acid (DHA) | Experimental | Dietary Supplement: Citicoline and Docosahexaenoic Acid (DHA)Cebrolux 800 and Brudypio 1.5g (see above). |
| Vitamin C | Experimental | Dietary Supplement: Vitamin CVitamin C. |
Who may qualify
- Ages
- 50 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Patients with chronic, primary or secondary, open or closed angle glaucoma, diagnosed by meeting the following criteria:
- There must be at least 3 reliable visual fields prior to the start of the study.
- Patients between 50 and 75 years old, homogeneously distributed among the groups.
- Glaucoma with functional and structural damage.
Key exclusion criteria (5 listed)
- Treatment with some other vitamin or nutraceutical preparation.
- Any pathology that can alter the visual field. (Neurological diseases, retinopathies, advanced cataract, patients treated with lyrica (due to the affectation it produces in the visual field)).
- Hypersensitivity to aspirin. (Cross-allergic reaction has been reported in patients taking citicoline.)
- Allergic to fish protein.
- Eye surgery in the 3 months before or 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 |
|---|---|---|
| CiticolineAlso: Cebrolux 800Every subject randomized into this group have to take 2 sachets of Cebrolux 800 (362 mg of citicoline per day), every day, for 3 months. | Dietary supplement | Citicoline |
| Docosahexaenoic Acid (DHA)Also: Brudypio 1.5gEvery subject randomized into this group have to take 3 pills of Brudypio 1.5g (1050 mg of DHA per day), every day, for 3 months. | Dietary supplement | Docosahexaenoic Acid (DHA) |
| Citicoline and Docosahexaenoic Acid (DHA)Every subject randomized into this group have to take 2 sachets of Cebrolux 800 and 3 pills of Brudypio 1.5g per day, every day, for 3 months. | Dietary supplement | Citicoline and Docosahexaenoic Acid (DHA) |
| Vitamin CAlso: L-ascorbic acidEvery subject randomized into this group have to take 1 pills of Vitamin C (500 mg per day), every day, for 3 months. | Dietary supplement | Vitamin C |
Primary outcome
Effect on Mean Defect (MD)
Time frame: From Baseline to Month 3.
Evaluation of changes on the MD (decibels) with study treatment.
Effect on Visual Field Index (VFI)
Time frame: From Baseline to Month 3.
Evaluation of changes on the VFI (%) with study treatment.
2 secondary outcomes
Evaluation of the changes produced in the intraocular pressure (IOP)
Time frame: From Baseline to Month 3.
Evaluation of tolerance
Time frame: From Month 1 to Month 3
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2022.
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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. This study is not recruiting at the moment.
Alfonso Anton, MD, PhD principal investigator
Institut Catala de Retina
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Citicoline, Docosahexaenoic Acid (DHA) and Citicoline and Docosahexaenoic Acid (DHA) in people with Glaucoma, run by Institut Catala de Retina at 1 site 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 8 inclusion and 5 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: finished, as of the sponsor's last update on 2 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effect on Mean Defect (MD) (time frame: From Baseline to Month 3.). 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 2 Sep 2022.