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

Glaucoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06333236
• Other study ID #: OCU_KRON
• Status: Not yet recruiting
• Phase: N/A
• Start date: March 25, 2024
• Est. completion date: November 30, 2024

Study information

• Verified date: January 2024
• Source: ASST Santi Paolo e Carlo
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: November 30, 2024
• Est. primary completion date: September 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Glaucoma
• Glaucoma, Open-Angle

Intervention

Other:
• Food for Special Medical Purposes: Kron®
Citicoline 40mg/ml + Nicotinamide 15 mg/ml oral solution

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
ASST Santi Paolo e Carlo

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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