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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Glaucoma
• Intervention / Treatment: Other: Food for Special Medical Purposes: Kron®

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

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Other: Food for Special Medical Purposes: Kron®; Citicoline 40mg/ml + Nicotinamide 15 mg/ml oral solution
No Intervention: Control Group; No interviention in addition to the IOP-lowering medications.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	3 months

Collaborators and Investigators

• Sponsor: ASST Santi Paolo e Carlo

Study record dates

Study Major Dates

• Study Start (Estimated): March 25, 2024
• Primary Completion (Estimated): September 30, 2024
• Study Completion (Estimated): November 30, 2024

Study Registration Dates

• First Submitted: February 1, 2024
• First Submitted That Met QC Criteria: March 20, 2024
• First Posted (Actual): March 27, 2024

Study Record Updates

• Last Update Posted (Actual): March 27, 2024
• Last Update Submitted That Met QC Criteria: March 20, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Ocular Hypertension; Glaucoma; Glaucoma, Open-Angle
• Other Study ID Numbers: OCU_KRON

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No