An interventional study of Food for Special Medical Purposes: Kron® in Glaucoma, sponsored by ASST Santi Paolo e Carlo. Completed at 2 sites in Italy. Open to participants aged 40 Years to 70 Years. Per ClinicalTrials.gov, last updated 2025-09-22.
Sponsored by ASST Santi Paolo e Carlo · Not applicable, Interventional, and Treatment
Aim of this study is to investigate the administration effects of the combination of citicoline 40mg/ml and nicotinamide 15mg/ml oral solution (Kron®) on short term improvement in inner retinal function, bioelectrical activity of the visual cortex and visual function.
Prospective, masked, randomized placebo-controlled study to evalute the offect of the oral solution Kron® (citicoline 40mg/ml and nicotinamide 15mg/ml) on patients with a diagnosis of open angle glaucoma and risk of glaucoma progression.
Glaucomatous patients with a diagnosis of open angle glaucoma and risk of glaucoma progression who meet the study criteria will be enrolled and randomly assign to the following two arms:
Once recruited, a clinical evaluator will perform a comprehensive ophthalmologic evaluation at baseline, week 6 and week 12. The following examinations will be done in the following sequence:
1,818 studies on the registry are indexed under Glaucoma; 231 are open to participants now.
This study's enrollment of 30 is below the median of 65 across 1,272 interventional studies indexed under Glaucoma.
Browse Glaucoma studies →ASST Santi Paolo e Carlo is the lead sponsor of 5 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Active Treatment: Kron® (300ml) oral solution containing citicoline free acid 40 mg/ml; nicotinamide 15 mg/ml. In addition to the IOP-lowering medications, Kron will be administered at a dosage of 10 ml in the morning. To each patient will be given two bottles during the baseline visit and will be asked to return them at the end of the study (3 month) for the compliance assessment.
Other: Food for Special Medical Purposes: Kron®
No interviention in addition to the IOP-lowering medications.
Citicoline 40mg/ml + Nicotinamide 15 mg/ml oral solution
Electrofunctional evaluation
Short term improvement in inner retinal function and bioelectrical activity of the visual cortex evaluated by means of PERG (P50 and N95 peaks) and PEV (P100 implicit time and N75-P100 amplitude) pattern.
Time frame: 3 months
VF and SD-OCT
Visual field examination will be performed at the beginning and at the end of trial. Standard pattern short-term improvement in visual function in treated patients evaluated by means of VF. Retinal nerve fiber layer thickness, ganglion cell complex thickness and minimum rim width will be evaluated at the baseline and at the end of the study.
Time frame: 3 months
This study is completed, as verified in Sep 2025. You cannot join it, but the record below documents what was studied.
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ASST Santi Paolo e Carlo