Skip to main content
OpenTrials
Completed

NCT Number: NCT05527106

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Glaucoma Eye Diseases Ocular Hypertension

Age range

50 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Institut Catala de Retina

Barcelona, 08022, Spain

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

Citicoline

Dietary Supplement

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.

Other names: Cebrolux 800

Docosahexaenoic acid (DHA)

Dietary Supplement

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.

Other names: Brudypio 1.5g

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 C

Dietary Supplement

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

Other names: L-ascorbic acid

Primary outcomes

  1. Effect on Mean Defect (MD)

    Time frame: From Baseline to Month 3.

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

  2. Effect on Visual Field Index (VFI)

    Time frame: From Baseline to Month 3.

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

Secondary outcomes

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

    Time frame: From Baseline to Month 3.

    To compare IOP (mmHg) measurements with study treatment.

  2. Evaluation of tolerance

    Time frame: From Month 1 to Month 3

    Describe the tolerance and the adverse events with study treatment.

Sponsors and collaborators

Lead sponsor

Institut Catala de Retina

Other

Registry information

Official study 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

Important dates

Study start
2015
Primary completion
2022
Study completion
2022
First posted
Sep 2, 2022
Registry last updated
Sep 2, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.