GlaucomaNCT06333236
Effect of Kron (Citicoline and Nicotinamide Oral Solution) on Patients With Open-angle Glaucoma
A study testing Food for Special Medical Purposes: Kron® in people with Glaucoma, run by ASST Santi Paolo e Carlo at 2 sites in Italy.
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. Read more about this study
- Who is it for?
- Ages 40 to 70 years
- Conditions the study is for
- Glaucoma
- What is being tested?
- Food for Special Medical Purposes: Kron®
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 2 sitesItaly
- Study dates
- 10 Apr 2025to 14 Sep 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
2 sites in 1 country.
Italy2 sites
ASST Santi Paolo e Carlo
Milan, Mi, 20142
Luca Rossetti
Milan, MI, 20142
About this study
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.
Read the 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:
- Treatment group (TG): 20 patients will receive Citicoline 40 mg/ml + Nicotinamide 15 mg/ml oral solution for 3 months (10 ml/day)
- 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
- Being tested
- Food for Special Medical Purposes: Kron®
- Medical subject headings
- Glaucoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Food for Special Medical Purposes: Kron®Other
Citicoline 40mg/ml + Nicotinamide 15 mg/ml oral solution
| Study group | Role | What they receive |
|---|---|---|
| Group KRON | Experimental | 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. Receives: Other: Food for Special Medical Purposes: Kron® |
| Control Group | No intervention | No interviention in addition to the IOP-lowering medications. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 months
Secondary outcomes (1)
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.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2024
- Study start10 Apr 2025
- Primary completion15 Jul 2025
- Study completion14 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GlaucomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- ASST Santi Paolo e Carlo
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06333236
- Sponsor's protocol ID
- OCU_KRON
- Status last verified
- Sep 2025
- First submitted
- 1 Feb 2024
- Last updated
- 22 Sep 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Kron (Citicoline and Nicotinamide Oral Solution) on Patients With Open-angle Glaucoma
- ClinicalTrials.gov ID
- NCT06333236
- Acronym / sponsor ID
- OCU_KRON
- Conditions
- Glaucoma
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- ASST Santi Paolo e CarloUniversity, hospital or other
- Study start
- 10 Apr 2025 (actual)
- Primary completion
- 15 Jul 2025 (actual)
- Study completion
- 14 Sep 2025 (actual)
- First posted
- 27 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Treatment group (TG): 20 patients will receive Citicoline 40 mg/ml + Nicotinamide 15 mg/ml oral solution for 3 months (10 ml/day)
- 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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group KRON | Experimental | Other: Food for Special Medical Purposes: 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. |
| Control Group | No intervention | –No interviention in addition to the IOP-lowering medications. |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Food for Special Medical Purposes: Kron®Citicoline 40mg/ml + Nicotinamide 15 mg/ml oral solution | Other | Group KRON |
Primary outcome
Electrofunctional evaluation
Time frame: 3 months
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.
1 secondary outcome
VF and SD-OCT
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Food for Special Medical Purposes: Kron® in people with Glaucoma, run by ASST Santi Paolo e Carlo at 2 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Electrofunctional evaluation (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Sep 2025.