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

Glaucoma Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05527106
• Other study ID #: ICR-14/13
• Status: Completed
• Phase: N/A
• Start date: March 12, 2015
• Est. completion date: May 25, 2022

Study information

• Verified date: September 2022
• Source: Institut Catala de Retina
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 73
• Est. completion date: May 25, 2022
• Est. primary completion date: May 25, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Glaucoma

Intervention

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.
• 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.
• 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.
• 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.

Locations

Country	Name	City	State
Spain	Institut Catala de Retina	Barcelona

Sponsors (1)

Lead Sponsor	Collaborator
Institut Catala de Retina

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Effect on Mean Defect (MD)	Evaluation of changes on the MD (decibels) with study treatment.	From Baseline to Month 3.
Primary	Effect on Visual Field Index (VFI)	Evaluation of changes on the VFI (%) with study treatment.	From Baseline to Month 3.
Secondary	Evaluation of the changes produced in the intraocular pressure (IOP)	To compare IOP (mmHg) measurements with study treatment.	From Baseline to Month 3.
Secondary	Evaluation of tolerance	Describe the tolerance and the adverse events with study treatment.	From Month 1 to Month 3