Effect of Kron (Citicoline and Nicotinamide Oral Solution) on Patients With Open-angle Glaucoma

NCT ID: NCT06333236

Last Updated: 2025-09-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-04-10
• Study Completion Date: 2025-09-14

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.

Detailed Description

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:

1. Treatment group (TG): 20 patients will receive Citicoline 40 mg/ml + Nicotinamide 15 mg/ml oral solution for 3 months (10 ml/day)

2. Control group (CG): 10 patients will be evaluated as control

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:

• Visual acuity
• Slit lamp evaluation
• PERG
• PEV pattern
• Tonometry
• Visual field
• Optical Coherence Tomography
• Dilated Fundus examination

Conditions

Glaucoma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Group KRON

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.

Group Type: EXPERIMENTAL

Food for Special Medical Purposes: Kron®

Intervention Type: OTHER

Citicoline 40mg/ml + Nicotinamide 15 mg/ml oral solution

Control Group

No interviention in addition to the IOP-lowering medications.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Food for Special Medical Purposes: Kron®

Citicoline 40mg/ml + Nicotinamide 15 mg/ml oral solution

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

ASST Santi Paolo e Carlo

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

ASST Santi Paolo e Carlo

Milan, Mi, Italy

Luca Rossetti

Milan, MI, Italy

Countries

Italy

Other Identifiers

OCU_KRON

Identifier Type: -

Identifier Source: org_study_id