Effect of Kron (Citicoline and Nicotinamide Oral Solution) on Patients With Open-angle Glaucoma
1 other identifier
interventional
30
1 country
2
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Apr 2025
Shorter than P25 for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 1, 2024
CompletedFirst Posted
Study publicly available on registry
March 27, 2024
CompletedStudy Start
First participant enrolled
April 10, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 15, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
September 14, 2025
CompletedSeptember 22, 2025
September 1, 2025
3 months
February 1, 2024
September 17, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
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.
3 months
Secondary Outcomes (1)
VF and SD-OCT
3 months
Study Arms (2)
Group KRON
EXPERIMENTALActive 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.
Control Group
NO INTERVENTIONNo interviention in addition to the IOP-lowering medications.
Interventions
Citicoline 40mg/ml + Nicotinamide 15 mg/ml oral solution
Eligibility Criteria
You may qualify if:
- glaucomatous patients with moderate visual field loss, MD ranging from -6 dB and -12 dB, and risk of progression
- controlled intraocular pressure
- at least 3 previous visual field examinations.
You may not qualify if:
- angle closure glaucoma and secondary open angle glaucoma
- refractive error outside +2D and -6D
- ophthalmic surgery 6 months before the recruitment
- presence of cataract or other conditions that could affect results of perimetry or electroretinography
- treatment with supplements in any form with a demonstrated or presumed neuroprotecting/neuroenhancing effect in the last six months
- presence of other ocular or systemic diseases that could affect results of perimetry or electroretinography.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
ASST Santi Paolo e Carlo
Milan, Mi, 20142, Italy
Luca Rossetti
Milan, MI, 20142, Italy
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 1, 2024
First Posted
March 27, 2024
Study Start
April 10, 2025
Primary Completion
July 15, 2025
Study Completion
September 14, 2025
Last Updated
September 22, 2025
Record last verified: 2025-09