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

ASST Santi Paolo e Carlo

Status: Completed

Conditions: Glaucoma

Treatments: Other: Food for Special Medical Purposes: Kron®

Study type: Interventional

Funder types: Other

Identifiers

NCT06333236

OCU_KRON

Details and patient eligibility

About

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.

Full 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

Enrollment: 30 patients

Sex: All

Ages: 40 to 70 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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30 participants in 2 patient groups

Group KRON

Experimental group

Description:

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.

Treatment:

Other: Food for Special Medical Purposes: Kron®

Control Group

No Intervention group

Description:

No interviention in addition to the IOP-lowering medications.