the general purpose of the study is to evaluate the potential beneficial effects of supplementation of a fixed combination of Citicoline 500 mg plus Homotaurine 50 mg on retinal ganglion cells (RGCs) function in subjects with glaucoma by pattern electroretinogram.
Secondary objectives are to assess effects on visual acuity, visual field changes, Quality of Life perception (NEI VFQ25 questionnaire), and safety (Incidence of adverse events)
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
63
Citicoline 500 mg plus Homotaurine 50 mg was added to topical therapy
Dario Sisto
Bari, bari, Italy
Gemma Caterina Maria Rossi
Pavia, PV, Italy
Alberto Mavilio
Brindisi, Italy
Teresa Rolle
Torino, Italy
To assess effects of adding the fixed combination of Citicoline 500 mg plus Homotaurine 50 mg (Neuprozin® - NP), one tablet a day, on PERG examination at four months of therapy, compared to standard of care alone, as add-on to standard therapy
changes in amplitude (microVolt)
Time frame: 4 months of therapy 2 months of wash out 4 months without adding therapy
To assess effects of one tablet a day of the fixed combination of Citicoline 500 mg plus Homotaurine 50 mg (Neuprozin® - NP) on visual acuity
changes in visual acuity (decimals)
Time frame: 4 months of therapy 2 months of wash out 4 months without adding therapy
to assess effects of one tablet a day of the fixed combination of Citicoline 500 mg plus Homotaurine 50 mg (Neuprozin® - NP) on visual field
changes in mean deviation (deciBell-dB) and in pattern standard deviation (deciBell-dB) of visual field parameters
Time frame: 4 months of therapy 2 months of wash out 4 months without adding therapy
to assess effects of one tablet a day of the fixed combination of Citicoline 500 mg plus Homotaurine 50 mg (Neuprozin® - NP) on quality of life
changes in the total mean score and in the subscales of the 25 item National Eye Institute - Visual Functioning Questionnaire (NEI VFQ25) (scores are presented as a number, higher numbers reflect higher QL)
Time frame: 4 months of therapy 2 months of wash out 4 months without adding therapy
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