Phase
Condition
Glaucoma
Treatment
Citicoline 500 mg plus Homotaurine 50 mg plus Pyrroloquinoline quinone (Neuprozin Mito® )
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
age > 18 years;
diagnosis of primary OAG (POAG) from, at least, 3 years;
visual acuity > 0.7 (7/10) decimals;
refractive error < 5 Diopter (D) (spheric) and < 2D (toric);
transparent diopter means (cornea and lens);
controlled intraocular pressure (IOP) (<18 mmHg, morning value) with prostaglandinanalogues as monotherapy;
stable intraocular pressure - IOP < 18 mmHg in the last 2 years;
stable and unchanged topical therapy in the last 6 months;
at least two reliable visual fields (Humphrey 24-2 Swedish interactive thresholdalgorithm-SITA Standard) per year in the last 2 years;
early to moderate visual field defect (mean deviation, MD <12 dB);
electrophysiological (pattern electroretinogram-PERG) parameters alterations similarto glaucomatous pathology;
written consent to participate to study procedures and data utilization in ananonymous form
Exclusion
Exclusion Criteria:
ocular hypertension with normal optic nerve and visual field; angle closureglaucoma; congenital glaucoma; secondary glaucoma; normal tension glaucoma;
history of recurrent uveitis/scleritis/herpes infection;
pregnancy and breastfeeding;
contraindication to Citicoline and/or Homotaurine and/or pyrroloquinoline quinone -PQQ
contraindication to prostaglandine analogues
topical therapy with Brimonidine or beta-blockers as monotherapy or fixedcombination
topical therapy with pilocarpine and aceclidine, monotherapy or fixed combination
systemic or topical treatment with another neuroprotective agent in the last 4months prior to enrollment
systemic betablockers
systemic therapies affecting patients' performance in visual field examination (sedatives);
glaucomatous scotomas within 10 degree from fixation
any condition limiting the patient's ability to participate in the study;
other ocular causes of visual field and PERG changes, such as cataract, myopicchorioretinopathy, macular diseases, retinal vascular occlusion, diabeticretinopathy;
other systemic causes of visual field and PERG changes such as neurodegenerativedisorders (Alzheimer's disease, Parkinson's disease, acute lateral sclerosis,multiple sclerosis) or pituitary disorders;
cerebral ischemia in the last 2 years
any change in topical therapy in the 6 months prior to enrollment or during thestudy period
concomitant participation to another clinical trial
any previous filtering and/or retinal surgery;
cataract surgery in the last 6 months;
any previous laser treatment for glaucoma in the last 5 years
Study Design
Study Description
Connect with a study center
Gemma Caterina Maria Rossi
Pavia, PV 27100
ItalySite Not Available
Clinica Oculistica Università Federico II
Napoli, 80100
ItalySite Not Available
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