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

Launched by OMIKRON ITALIA S.R.L. · Jan 24, 2023

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ClinConnect Summary

This clinical trial is studying the effectiveness of citicoline eye drops (2%) in helping to preserve vision for patients with open-angle glaucoma (OAG), a condition where pressure in the eye can lead to vision loss. Researchers want to find out if these eye drops can slow down the decline in visual field, which is how much of the world you can see out of the corner of your eyes. They will also look at any changes in the structure of the eye using a special imaging test and assess how safe the eye drops are for patients.

To participate in the trial, you must be at least 18 years old and diagnosed with open-angle glaucoma, pseudoexfoliation glaucoma, or pigmentary glaucoma. Your vision should be stable, with specific criteria for visual field measurements and eye pressure. If you decide to join, you can expect regular check-ups to monitor your vision and eye health while using the citicoline drops. It’s important to note that certain conditions, such as recent eye surgeries or other eye diseases, may prevent you from being eligible for the study.

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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 tests were SITA Faster; additional SITA Faster if \> 2 tests were SITA Faster).
• • 8. 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.
• • 9. Women of childbearing potential willing to use an appropriate method of contraception.
• Exclusion Criteria:
• • 1. Cataract in the study eye which, in the opinion of the clinician, may require cataract surgery within the next three years.
• • 2. Only-eye patients (visual acuity \< 0.1 decimals in one eye or more than two paracentral VF locations with a sensitivity of \< 10 dB).
• • 3. Known intolerance or allergy to any of the components in the eye drops.
• • 4. Diode laser treatment or glaucoma surgery in the past 2 years or cataract surgery within the last 6 months in the study eye.
• • 5. Eyes with any type of glaucoma other than primary, pseudoexfoliative or pigmentary OAG.
• • 6. Patients with other ocular or systemic comorbidities that, in the opinion of the Investigator, might affect the VF or the execution of the test.
• • 7. Patients already on topical or systemic citicoline treatment.
• • 8. 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.
• • 9. 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%.
• • 10. Pregnant and nursing patients.