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CompletedNCT05527106Updated Sep 2, 2022

Evaluation of the Effect of Citicoline and Docosahexaenoic Acid (DHA) on the Visual Function of Patients With Glaucoma

An interventional study of Citicoline and Docosahexaenoic Acid (DHA) in Glaucoma, sponsored by Institut Catala de Retina. Completed at 1 site in Spain. Open to participants aged 50 Years to 75 Years. Per ClinicalTrials.gov, last updated 2022-09-02.

Sponsored by Institut Catala de Retina · Not applicable, Interventional, and Supportive care

From the registry’s dates

  • Registered 7 years 5 months after the study started (first participant enrolled Mar 2015, registered Aug 2022).
Phase
Not applicable
Study type
Interventional
Enrollment
73
Allocation
Randomized
Ages
50 Years to 75 Years
Sex
All
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Study 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.

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Conditions studied

  • Glaucoma

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Keywords

  • glaucoma
  • nutraceuticals
  • dha (docosahexaenoic acid)
  • citicoline
03

In context

Glaucoma

1,818 studies on the registry are indexed under Glaucoma; 231 are open to participants now.

This study's enrollment of 73 is above the median of 65 across 1,272 interventional studies indexed under Glaucoma.

Browse Glaucoma studies →

Lead sponsor

Institut Catala de Retina is the lead sponsor of 3 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
50 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. 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.
  2. There must be at least 3 reliable visual fields prior to the start of the study.
  3. Patients between 50 and 75 years old, homogeneously distributed among the groups.
  4. Glaucoma with functional and structural damage.

    • Medium grade, Mean Deviation (MD) between -4 and -20 dB.
    • In at least one eye.

Exclusion criteria

Exclusion Criteria:

  1. Treatment with some other vitamin or nutraceutical preparation.
  2. 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)).
  3. Hypersensitivity to aspirin. (Cross-allergic reaction has been reported in patients taking citicoline.)
  4. Allergic to fish protein.
  5. Eye surgery in the 3 months before or during the study.
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Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Investigator)
Enrollment
73 participants (actual)

Study arms

  • Experimental
    Citicoline

    Cebrolux 800 is a food supplement based on citicoline (163 mg) that also contains vitamin A, E, C and B6.

    Dietary Supplement: Citicoline

  • Experimental
    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).

    Dietary Supplement: Docosahexaenoic Acid (DHA)

  • Experimental
    Citicoline and Docosahexaenoic Acid (DHA)

    Cebrolux 800 and Brudypio 1.5g (see above).

    Dietary Supplement: Citicoline and Docosahexaenoic Acid (DHA)

  • Experimental
    Vitamin C

    Vitamin C.

    Dietary Supplement: Vitamin C

Interventions

  • Dietary supplementCiticoline

    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.

    Also known as: Cebrolux 800

  • Dietary supplementDocosahexaenoic Acid (DHA)

    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.

    Also known as: Brudypio 1.5g

  • Dietary supplementCiticoline 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 supplementVitamin C

    Every subject randomized into this group have to take 1 pills of Vitamin C (500 mg per day), every day, for 3 months.

    Also known as: L-ascorbic acid

06

What researchers measure

Primary outcomes

  1. Effect on Mean Defect (MD)

    Evaluation of changes on the MD (decibels) with study treatment.

    Time frame: From Baseline to Month 3.

  2. Effect on Visual Field Index (VFI)

    Evaluation of changes on the VFI (%) with study treatment.

    Time frame: From Baseline to Month 3.

Secondary outcomes

  1. Evaluation of the changes produced in the intraocular pressure (IOP)

    To compare IOP (mmHg) measurements with study treatment.

    Time frame: From Baseline to Month 3.

  2. Evaluation of tolerance

    Describe the tolerance and the adverse events with study treatment.

    Time frame: From Month 1 to Month 3

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Study locations

1 site
  • Institut Catala de Retina
    Barcelona, 08022, Spain
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 2, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05527106
Lead sponsor
Institut Catala de Retina
Responsible party
Sponsor
First posted
Sep 2, 2022
Start date
Mar 12, 2015
Primary completion
May 25, 2022
Completion
May 25, 2022
Last update
Sep 2, 2022

Study contacts

Alfonso Anton, MD, PhD
principal investigator · Institut Catala de Retina

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2022. You cannot join it, but the record below documents what was studied.

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