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Recruiting Phase 3 NCT05710198

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

Trial Parameters

Condition Glaucoma, Open-Angle
Sponsor Omikron Italia S.r.l.
Study Type INTERVENTIONAL
Phase Phase 3
Enrollment 1,000
Sex ALL
Min Age 18 Years
Max Age N/A
Start Date 2023-12-11
Completion 2026-04-01
Interventions
Citicoline eye drops 2%Placebo

Brief 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 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 test

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