Omikron Italia S.r.l.
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%
Glaucoma, Open-Angle
Citicoline eye drops 2%
Placebo
Phase 3
Background: Primary open angle glaucoma (OAG) is a chronic progressive neurodegenerative disease where intraocular pressure (IOP) is the main and successfully treatable risk factor. Although the treatment effect is quite large, a significant proportion of patients show disease progression with apparently well controlled IOP. Given the similarities with other neurodegenerative diseases - particularly in the mechanisms of cell death - neuroprotective treatments have been tested also in glaucoma. Interesting results from experimental studies and first evidence from human glaucoma trials have been published in recent years. Citicoline is one of the promising molecules with a putative neuroprotective action and has been evaluated in patients with various neurodegenerative diseases with encouraging results. The mechanism of action of citicoline is multifarious and includes preservation of cardiolipin and sphingomyelin, restoration of phosphatidylcholine, stimulation of glutathione synthesis, lowering of glutamate concentration, rescuing mitochondrial function, and others. Pilot studies on glaucomatous patients showed a possible effect of citicoline as additive therapy in the treatment of glaucoma, in reducing progression of visual field changes, in protecting retinal nerve fiber layers and in improving vision related Quality of Life (QoL), though these findings are yet to be confirmed by a large randomized clinical trial.
Study Type : | Interventional |
Estimated Enrollment : | 1000 participants |
Masking: | Quadruple |
Masking Description: | Double-blind |
Primary Purpose: | Prevention |
Official Title: | 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 |
Actual Study Start Date : | December 11, 2023 |
Estimated Primary Completion Date : | April 1, 2026 |
Estimated Study Completion Date : | April 1, 2027 |
Arm | Intervention/treatment |
---|---|
Experimental: citicoline eye drops 2% 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 Comparator: Placebo eye drops 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 |
Ages Eligible for Study: | 18 Years |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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Recruiting
Presidio Ospedale San Paolo
Milano, MI, Italy, 20142