Efficacy of Citicoline Eye Drops 2% on Visual Field Preservation in Patients With Open Angle Glaucoma

NCT05710198 | Recruiting Phase 3

• 1 other identifier: OMK1P3
• Study Type: interventional
• Target: 1,000
• Locations: 1 country
• Sites: 1

Brief Summary

To evaluate the efficacy of citicoline eye drops 2% in reducing visual field deterioration in patients with progressing OAG treated according to best clinical practice. Secondary objectives are assessing the effect of citicoline eye drops 2% on changes in structural parameters measured by Spectral Domain Optical Coherence Tomography (SD-OCT) and evaluating the safety of citicoline eye drops 2%

Conditions

Glaucoma, Open-Angle

Keywords

Glaucoma; Citicoline; Visual field; Open-Angle glaucoma

Outcome Measures

Primary Outcomes (1)

• Progression of visual field damage

  Difference in the rate of progression of VF damage in the study eye between the two trial arms. This will be measured with repeated, planned visual field (VF) tests, all performed with a Humphrey Field Analyser (HFA, Zeiss Meditec, Dublin, CA) with the SITA Standard 24-2 strategy, over the span of three years.

  3 years

Secondary Outcomes (3)

• Rate of progression in structural parameters

  3 years

• Safety (IOP)

  3 years

• Visual Field recovery

  3 years

Study Arms (2)

citicoline eye drops 2%

EXPERIMENTAL

Citicoline eye drops 2%. One drop in the study eye three times daily throughout the 3-year trial. Patients will be treated with any IOP-lowering agent to control IOP and study treatments should be administered at least 20 minutes after IOP lowering medication.

Drug: Citicoline eye drops 2%

Placebo eye drops

PLACEBO COMPARATOR

Placebo eye drops. One drop in the study eye three times daily throughout the 3-year trial. Patients will be treated with any IOP-lowering agent to control IOP and study treatments should be administered at least 20 minutes after IOP lowering medication

Drug: Placebo

Interventions

Citicoline eye drops 2% DRUG

Eye drops containing Citicoline 2%

citicoline eye drops 2%

Placebo DRUG

Eye drops containing placebo matching product

Placebo eye drops

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Signed written informed consent.
• Age ≥ 18 years.
• Eyes with OAG, Pseudoexfoliation and pigmentary glaucoma will be included.
• Best Corrected Visual Acuity (BCVA) ≥ 0.5 for the study eye.
• Controlled IOP (≤ 18 mmHg, average of the last 3 measurements in the clinic) in the study eye.
• Visual field MD not worse than -12 dB at the latest assessment in the clinic for the study eye.
• Deteriorating MD at a rate between -0.5 dB/year and -1.0 dB/year, estimated from the latest VF tests collected in the clinic (at least 4) over a period during which incisional glaucoma surgery was not performed. Combinations of SITA Standard and Fast strategies (but not SITA Faster) is admissible. Patients who reach the desired minimum number of tests (4) with a mixture of SITA Standard/Fast and SITA Faster tests will need to perform additional replacement tests according to the prevalent strategy used in their series of VF (i.e. additional SITA Standard/Fast tests if ≤ 2 tests were SITA Faster; additional SITA Faster if \> 2 tests were SITA Faster).
• Glaucoma definition will be based on VF damage (24-2, any SITA strategy) and spatially congruent glaucomatous changes at the ONH. If both eyes are eligible, the eye with the better MD will be chosen as the study eye.
• Women of childbearing potential willing to use an appropriate method of contraception.

You may not qualify if:

• Cataract in the study eye which, in the opinion of the clinician, may require cataract surgery within the next three years.
• Only-eye patients (visual acuity \< 0.1 decimals in one eye or more than two paracentral VF locations with a sensitivity of \< 10 dB).
• Known intolerance or allergy to any of the components in the eye drops.
• Diode laser treatment or glaucoma surgery in the past 2 years or cataract surgery within the last 6 months in the study eye.
• Eyes with any type of glaucoma other than primary, pseudoexfoliative or pigmentary OAG.
• Patients with other ocular or systemic comorbidities that, in the opinion of the Investigator, might affect the VF or the execution of the test.
• Patients already on topical or systemic citicoline treatment.
• Patients taking other systemic or topical potential neuroprotectors competing with citicoline eye drops 2% (a list will be provided) unwilling to suspend these treatments and undergo a washout period of 6 months prior to the study.
• Patients unable to perform reliable VF tests, based on the assessment of the last 4 available 24-2 Humphrey Field Analyzer (HFA) VF tests performed in the clinic with a false positive rate (FP) ≤ 15%.
• Pregnant and nursing patients.

Sponsors & Collaborators

• Omikron Italia S.r.l.: lead
• OPIS Spain: collaborator

Study Sites (1)

Presidio Ospedale San Paolo

Milan, MI, 20142, Italy

RECRUITING

Related Publications (1)

• Cavaterra D, Giammaria S, Pandino I, Zingale GA, Delli Paoli V, Fiore R, Michelessi M, Roberti G, Carnevale C, Tanga L, Cazzato D, Peroni E, Grasso G, Manni G, Bocedi A, Oddone F, Coletta M, Sbardella D, Tundo GR. Citicoline Triggers Proteome Remodeling and Proteostatic Adaptation: Evidence from Shotgun Proteomics. Pharmaceutics. 2026 Jan 1;18(1):61. doi: 10.3390/pharmaceutics18010061.

  PMID: 41599168 DERIVED

MeSH Terms

Conditions

Glaucoma, Open-Angle; Glaucoma

Condition Hierarchy (Ancestors)

Ocular Hypertension; Eye Diseases

Central Study Contacts

Carla Russo

CONTACT

+39 06 80693572; c.russo@omikronitalia.it

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Double-blind
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Multicenter, double-blind, randomized, placebo-controlled, parallel-group trial

Study Record Dates

• First Submitted: January 24, 2023
• First Posted: February 2, 2023
• Study Start: December 11, 2023
• Primary Completion: April 1, 2026
• Study Completion (Estimated): April 1, 2027
• Last Updated: March 12, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)