Glaucoma, Open-AngleNCT06355765
Citicoline & Antioxidants in Glaucoma
An observational study of Glaucoma, Open-Angle, run by University of Naples at 1 site in Italy.
Trial summary
To evaluate the long-term effects of oral citicoline, vitamins A, B, C and E, and blackcurrant therapy in patients with primary open-angle glaucoma (POAG) using optical coherence tomography (OCT), OCT angiography (OCTA) and microperimetry parameters. Read more about this study
- Who is it for?
- Ages 30 to 90 years
- Conditions the study is for
- Glaucoma, Open-Angle
- What is being tested?
- Citicoline blackcurrant supplement
- Type of treatment
- Pill or oral medicine
- How many people
- 60 participants
- Where
- 1 siteItaly
- Study dates
- 10 Jan 2022to 10 Dec 2022
- How long will I take part?
- 1 Year
- Phase
- Observational
- 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 30 to 90 years
- All sexes
- Adult, Older adult
Study population: primary care clinic
Who may be able to join
- diagnosis of POAG
- aged between 18 and 75 years
- Patients with controlled intraocular pressure (IOP) below 20 mmHg, who had been on the same topical hypotensive therapy for at least 3 months
- myopia less than 5 diopters (D) were considered eligible for inclusion.
Who cannot join
- IOP levels exceeding 21 mmHg,
- hyper-sensitivity to citicoline,
- a history of optic neuritis,
- previous glaucoma or retinal surgery,
- prior cataract or refractive surgery,
- macular degeneration or other retinal disorders,
- any systemic diseases that could potentially lead to neurodegeneration (e.g., multiple sclerosis, diabetes)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Oral Citicoline, Vitamins A, B, C and E, and Blackcurrant in Primary Open-Angle Glaucoma With OCT and Angiography
To evaluate the long-term effects of oral citicoline, vitamins A, B, C and E, and blackcurrant therapy in patients with primary open-angle glaucoma (POAG) using optical coherence tomography (OCT), OCT angiography (OCTA) and microperimetry parameters.
Read the detailed description
AIMS: To evaluate the long-term effects of oral citicoline, vitamins A, B, C and E, and blackcurrant therapy in patients with primary open-angle glaucoma (POAG) using optical coherence tomography (OCT), OCT angiography (OCTA) and microperimetry parameters.
METHODS: Fifteen patients with POAG (treated group) received one soluble liquid sachet daily for 20 days a month of a complementary dietary supplement containing in fixed combination citicoline, vitamins A, B, C, and E, and blackcurrant for 1 year. Fifteen age-matched subjects affected by POAG were given a placebo and served as a control group. The patients underwent best corrected visual acuity (BCVA), Goldmann applanation tonometry, microperimetry examination, OCT, and OCTA at the beginning of the study and then at 1, 6 and 12 months.
- Conditions
- Glaucoma, Open-Angle
- Being tested
- Citicoline blackcurrant supplement
- Medical subject headings
- Glaucoma, Open-Angle
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Citicoline blackcurrant supplementDietary supplement
Citicoline, Vitamins A, B, C and E, and Blackcurrant
| Study group | Role | What they receive |
|---|---|---|
| Citicoline blackcurrant | The treated group received a unique combination of oral dietary supplements, formulated in a soluble liquid sachet format for optimal absorption and convenience. This formulation included the following key components: citicoline (500 mg), vitamins A (300 μm), B group (4.415 mg), C (115 μm), and E (5 μm), and blackcurrant extract (50 mg). The participants in the treated group were instructed to take one sachet daily for 20 days each month, followed by a 10-day pause, and this therapy cycle was repeated throughout the 12-month follow-up period Receives: Dietary Supplement: Citicoline blackcurrant supplement | |
| Placebo | The treated group received a unique combination of oral placebo. The participants in the treated group were instructed to take one sachet daily for 20 days each month, followed by a 10-day pause, and this therapy cycle was repeated throughout the 12-month follow-up period |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of Ganglionar cells complex (GCC)
evaluate the long-term effects of oral citicoline, vitamins A, B, C and E, and blackcurrant therapy in patients with primary open-angle glaucoma (POAG) on GCC using optical coherence tomography (OCT)
Measured: From enrollment to the end of treatment at 1 year
Secondary outcomes (1)
Evaluation of Retinal nerve fiber layer (RNFL)
evaluate the long-term effects of oral citicoline, vitamins A, B, C and E, and blackcurrant therapy in patients with primary open-angle glaucoma (POAG) on RNFL using optical coherence tomography (OCT)
Measured: From enrollment to the end of treatment at 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2024
- Study start10 Jan 2022
- Primary completion10 Dec 2022
- Study completion10 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Glaucoma, Open-AngleStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 60 participants (actual)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- University of Naples
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Luca D'Andrea, University of Naples
- Investigators
- Luca D'Andrea, MD, Principal investigator, Federico II University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06355765
- Sponsor's protocol ID
- CITIZ_001
- Status last verified
- Apr 2024
- First submitted
- 4 Apr 2024
- Last updated
- 17 Apr 2024
- 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 17 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Oral Citicoline, Vitamins A, B, C and E, and Blackcurrant in Primary Open-Angle Glaucoma With OCT and Angiography
- ClinicalTrials.gov ID
- NCT06355765
- Acronym / sponsor ID
- CITIZ_001
- Conditions
- Glaucoma, Open-Angle
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University of NaplesUniversity, hospital or other
- Study start
- 10 Jan 2022 (actual)
- Primary completion
- 10 Dec 2022 (actual)
- Study completion
- 10 Dec 2022 (actual)
- First posted
- 9 Apr 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.
To evaluate the long-term effects of oral citicoline, vitamins A, B, C and E, and blackcurrant therapy in patients with primary open-angle glaucoma (POAG) using optical coherence tomography (OCT), OCT angiography (OCTA) and microperimetry parameters.
Detailed description
AIMS: To evaluate the long-term effects of oral citicoline, vitamins A, B, C and E, and blackcurrant therapy in patients with primary open-angle glaucoma (POAG) using optical coherence tomography (OCT), OCT angiography (OCTA) and microperimetry parameters.
METHODS: Fifteen patients with POAG (treated group) received one soluble liquid sachet daily for 20 days a month of a complementary dietary supplement containing in fixed combination citicoline, vitamins A, B, C, and E, and blackcurrant for 1 year. Fifteen age-matched subjects affected by POAG were given a placebo and served as a control group. The patients underwent best corrected visual acuity (BCVA), Goldmann applanation tonometry, microperimetry examination, OCT, and OCTA at the beginning of the study and then at 1, 6 and 12 months.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 1 Year
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Citicoline blackcurrant | – | Dietary Supplement: Citicoline blackcurrant supplementThe treated group received a unique combination of oral dietary supplements, formulated in a soluble liquid sachet format for optimal absorption and convenience. This formulation included the following key components: citicoline (500 mg), vitamins A (300 μm), B group (4.415 mg), C (115 μm), and E (5 μm), and blackcurrant extract (50 mg). The participants in the treated group were instructed to take one sachet daily for 20 days each month, followed by a 10-day pause, and this therapy cycle was repeated throughout the 12-month follow-up period |
| Placebo | – | –The treated group received a unique combination of oral placebo. The participants in the treated group were instructed to take one sachet daily for 20 days each month, followed by a 10-day pause, and this therapy cycle was repeated throughout the 12-month follow-up period |
Who may qualify
- Ages
- 30 to 90 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- primary care clinic
Key inclusion criteria (4 listed)
- diagnosis of POAG
- aged between 18 and 75 years
- Patients with controlled intraocular pressure (IOP) below 20 mmHg, who had been on the same topical hypotensive therapy for at least 3 months
- myopia less than 5 diopters (D) were considered eligible for inclusion.
Key exclusion criteria (7 listed)
- IOP levels exceeding 21 mmHg,
- hyper-sensitivity to citicoline,
- a history of optic neuritis,
- previous glaucoma or retinal surgery,
- prior cataract or refractive surgery,
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 |
|---|---|---|
| Citicoline blackcurrant supplementCiticoline, Vitamins A, B, C and E, and Blackcurrant | Dietary supplement | Citicoline blackcurrant |
Primary outcome
Evaluation of Ganglionar cells complex (GCC)
Time frame: From enrollment to the end of treatment at 1 year
evaluate the long-term effects of oral citicoline, vitamins A, B, C and E, and blackcurrant therapy in patients with primary open-angle glaucoma (POAG) on GCC using optical coherence tomography (OCT)
1 secondary outcome
Evaluation of Retinal nerve fiber layer (RNFL)
Time frame: From enrollment to the end of treatment at 1 year
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 17 Apr 2024.
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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.
Luca D'Andrea, MD principal investigator
Federico II University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Glaucoma, Open-Angle, run by University of Naples at 1 site 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 4 inclusion and 7 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 17 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Evaluation of Ganglionar cells complex (GCC) (time frame: From enrollment to the end of treatment at 1 year). 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 17 Apr 2024.