RecruitingPhase 3NCT05710198

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


Sponsor

Omikron Italia S.r.l.

Enrollment

1,000 participants

Start Date

Dec 11, 2023

Study Type

INTERVENTIONAL

Conditions

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%


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether citicoline eye drops (2%) can help preserve vision and slow the loss of visual field in patients with open-angle glaucoma, a condition where the optic nerve is gradually damaged. **You may be eligible if...** - You are 18 or older with a diagnosis of open-angle, pseudoexfoliation, or pigmentary glaucoma - Your eye pressure is well-controlled (18 mmHg or lower) - Your vision loss is mild to moderate (not worse than -12 dB on visual field testing) - Your vision is slowly declining at a rate of -0.5 to -1.0 dB per year - Your vision in the study eye is at least 50% of normal **You may NOT be eligible if...** - You are likely to need cataract surgery within the next 3 years - You have very poor vision in one eye - You are allergic to any ingredients in the eye drops - You have had glaucoma surgery or laser treatment in the past 2 years - You have any other type of glaucoma beyond the ones listed Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGCiticoline eye drops 2%

Eye drops containing Citicoline 2%

DRUGPlacebo

Eye drops containing placebo matching product


Locations(1)

Presidio Ospedale San Paolo

Milan, MI, Italy

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NCT05710198


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