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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Citicoline | Experimental | Cebrolux 800 is a food supplement based on citicoline (163 mg) that also contains vitamin A, E, C and B6. |
|
| Docosahexaenoic Acid (DHA) | Experimental | 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). |
|
| Citicoline and Docosahexaenoic Acid (DHA) | Experimental | Cebrolux 800 and Brudypio 1.5g (see above). |
|
| Vitamin C | Experimental | Vitamin C. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
|
| 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. |
| 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. |
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Inclusion Criteria:
Patients with chronic, primary or secondary, open or closed angle glaucoma, diagnosed by meeting the following criteria:
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.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Alfonso Anton, MD, PhD | Institut Catala de Retina | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institut Catala de Retina | Barcelona | 08022 | Spain |
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|
| 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. |
|
|
| 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. |
|
|
| From Month 1 to Month 3 |
| ID | Term |
|---|---|
| D005901 | Glaucoma |
| ID | Term |
|---|---|
| D009798 | Ocular Hypertension |
| D005128 | Eye Diseases |
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| ID | Term |
|---|---|
| D003566 | Cytidine Diphosphate Choline |
| D004281 | Docosahexaenoic Acids |
| D001205 | Ascorbic Acid |
| ID | Term |
|---|---|
| D002794 | Choline |
| D050337 | Trimethyl Ammonium Compounds |
| D000644 | Quaternary Ammonium Compounds |
| D000588 | Amines |
| D009930 | Organic Chemicals |
| D009861 | Onium Compounds |
| D003565 | Cytidine Diphosphate |
| D003597 | Cytosine Nucleotides |
| D011742 | Pyrimidine Nucleotides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D009711 | Nucleotides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D012265 | Ribonucleotides |
| D015525 | Fatty Acids, Omega-3 |
| D004042 | Dietary Fats, Unsaturated |
| D004041 | Dietary Fats |
| D005223 | Fats |
| D008055 | Lipids |
| D005231 | Fatty Acids, Unsaturated |
| D005227 | Fatty Acids |
| D005395 | Fish Oils |
| D009821 | Oils |
| D013400 | Sugar Acids |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D006880 | Hydroxy Acids |
| D002241 | Carbohydrates |
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