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

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.

Study Overview

• Status: Completed
• Conditions: Glaucoma
• Intervention / Treatment: Dietary supplement: Citicoline; Dietary supplement: Docosahexaenoic Acid (DHA); Dietary supplement: Citicoline and Docosahexaenoic Acid (DHA); Dietary supplement: Vitamin C

• Study Type: Interventional
• Enrollment (Actual): 73
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Barcelona, Spain, 08022
    • Institut Catala de Retina

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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:

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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; 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
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); 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
Experimental: Citicoline and Docosahexaenoic Acid (DHA); Cebrolux 800 and Brudypio 1.5g (see above).	Dietary supplement: 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.
Experimental: Vitamin C; Vitamin C.	Dietary supplement: Vitamin C; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Effect on Mean Defect (MD)	Evaluation of changes on the MD (decibels) with study treatment.	From Baseline to Month 3.
Effect on Visual Field Index (VFI)	Evaluation of changes on the VFI (%) with study treatment.	From Baseline to Month 3.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluation of the changes produced in the intraocular pressure (IOP)	To compare IOP (mmHg) measurements with study treatment.	From Baseline to Month 3.
Evaluation of tolerance	Describe the tolerance and the adverse events with study treatment.	From Month 1 to Month 3

Collaborators and Investigators

• Sponsor: Institut Catala de Retina
• Investigators: Principal Investigator: Alfonso Antón, MD, PhD, Institut Catala de Retina

Study record dates

Study Major Dates

• Study Start (Actual): March 12, 2015
• Primary Completion (Actual): May 25, 2022
• Study Completion (Actual): May 25, 2022

Study Registration Dates

• First Submitted: August 29, 2022
• First Submitted That Met QC Criteria: September 1, 2022
• First Posted (Actual): September 2, 2022

Study Record Updates

• Last Update Posted (Actual): September 2, 2022
• Last Update Submitted That Met QC Criteria: September 1, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Keywords: glaucoma; nutraceuticals; dha (docosahexaenoic acid); citicoline
• Additional Relevant MeSH Terms: Eye Diseases; Ocular Hypertension; Glaucoma; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Protective Agents; Micronutrients; Vitamins; Antioxidants; Nootropic Agents; Ascorbic Acid; Cytidine Diphosphate Choline
• Other Study ID Numbers: ICR-14/13

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No