Testing Citicoline Eye Drops Against Placebo in Open Angle Glaucoma

Trial details

Who runs it

Omikron Italia S.r.l.

Trial code

NCT05710198EU 2022-502273-42-00

Record updated

12 March 2024

Original description

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%Read full original descriptionShow less

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

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%

Inclusion: 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.

Exclusion: Cataract in the study eye which, in the opinion of the clinician, may require cataract surgery within the next three years; Diode laser treatment or glaucoma surgery in the past 2 years or cataract surgery within the last 6 months in the study eye; 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; Known intolerance or allergy to any of the components in the eye drops; Only-eye patients (visual acuity < 0.1 decimals in one eye or more than two paracentral VF locations with a sensitivity of < 10 dB); 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 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.

ClinicalTrials.gov NCT05710198 · EU CTIS 2022-502273-42-00