Citicoline eye drops for preserving vision in glaucoma patients

A Phase III Multicenter, Double-blind, Randomized, Placebo-controlled, Parallel-group Trial of the Efficacy of Citicoline Eye Drops 2% on Visual Field Preservation in Patients With Open Angle Glaucoma

This study is testing if 2% citicoline eye drops can help people with progressing open-angle glaucoma keep their vision from getting worse.

Quick facts

• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1000 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Omikron Italia S.r.l. (Industry-sponsored)
• Locations: 1 site (Milan, MI)
• Trial ID: NCT05710198 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the efficacy of 2% citicoline eye drops in reducing visual field deterioration in patients with progressing open-angle glaucoma (OAG). The study aims to assess not only the preservation of visual fields but also the impact of citicoline on structural changes in the eye, measured using Spectral Domain Optical Coherence Tomography (SD-OCT). Additionally, the safety profile of citicoline eye drops will be evaluated. Participants will receive either the citicoline treatment or a placebo, allowing for a comparison of outcomes between the two groups.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 and older with diagnosed open-angle glaucoma who are experiencing visual field deterioration despite controlled intraocular pressure.

Not a fit: Patients with advanced glaucoma or those who have undergone incisional glaucoma surgery may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could help preserve vision in patients with open-angle glaucoma, potentially improving their quality of life.

How similar studies have performed: Previous pilot studies have shown promising results for citicoline in glaucoma treatment, but this is a larger randomized clinical trial aimed at confirming those findings.

Eligibility criteria

Inclusion Criteria:

1. Signed written informed consent.
2. Age ≥ 18 years.
3. Eyes with OAG, Pseudoexfoliation and pigmentary glaucoma will be included.
4. Best Corrected Visual Acuity (BCVA) ≥ 0.5 for the study eye.
5. Controlled IOP (≤ 18 mmHg, average of the last 3 measurements in the clinic) in the study eye.
6. Visual field MD not worse than -12 dB at the latest assessment in the clinic for the study eye.
7. 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).
8. 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.
9. Women of childbearing potential willing to use an appropriate method of contraception.

Exclusion Criteria:

1. Cataract in the study eye which, in the opinion of the clinician, may require cataract surgery within the next three years.
2. Only-eye patients (visual acuity \< 0.1 decimals in one eye or more than two paracentral VF locations with a sensitivity of \< 10 dB).
3. Known intolerance or allergy to any of the components in the eye drops.
4. Diode laser treatment or glaucoma surgery in the past 2 years or cataract surgery within the last 6 months in the study eye.
5. Eyes with any type of glaucoma other than primary, pseudoexfoliative or pigmentary OAG.
6. Patients with other ocular or systemic comorbidities that, in the opinion of the Investigator, might affect the VF or the execution of the test.
7. Patients already on topical or systemic citicoline treatment.
8. 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.
9. 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%.
10. Pregnant and nursing patients.

Where this trial is running

Milan, MI

• Presidio Ospedale San Paolo — Milan, Mi, Italy (Recruiting)

Study contacts

• Study coordinator: Carla Russo

Conditions Glaucoma, Open-Angle; Glaucoma; Citicoline; Visual field; Open-Angle glaucoma