NCT05710198

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

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

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,000 (estimated)
• Sponsor: Omikron Italia S.r.l. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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%

Detailed description

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.

Conditions

• Glaucoma, Open-Angle

Interventions

Type	Name	Description
DRUG	Citicoline eye drops 2%	Eye drops containing Citicoline 2%
DRUG	Placebo	Eye drops containing placebo matching product

Timeline

• Start date: 2023-12-11
• Primary completion: 2026-04-01
• Completion: 2027-04-01
• First posted: 2023-02-02
• Last updated: 2024-03-12

Locations

1 site across 1 country: Italy