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

Not Applicable

Completed

• Conditions: Glaucoma
• Interventions: Dietary Supplement: Citicoline and Docosahexaenoic Acid (DHA); Dietary Supplement: Docosahexaenoic Acid (DHA); Dietary Supplement: Vitamin C; Dietary Supplement: Citicoline

• Registration Number: NCT05527106
• Lead Sponsor: Institut Catala de Retina

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-03-12
• Primary Completion: 2022-05-25
• Study Completion: 2022-05-25
• Study First Submitted: 2022-08-29
• Status Verified: 2022-09
• Study First Submitted QC: 2022-09-01
• Last Update Submitted: 2022-09-01
• Study First Posted: 2022-09-02
• Last Update Posted: 2022-09-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 73

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Citicoline and Docosahexaenoic Acid (DHA)	Citicoline and Docosahexaenoic Acid (DHA)	Cebrolux 800 and Brudypio 1.5g (see above).
Docosahexaenoic Acid (DHA)	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).
Vitamin C	Vitamin C	Vitamin C.
Citicoline	Citicoline	Cebrolux 800 is a food supplement based on citicoline (163 mg) that also contains vitamin A, E, C and B6.

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Institut Catala de Retina; 🇪🇸 Barcelona, Spain