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| Name | Class |
|---|---|
| University of Milan | OTHER |
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Double-blind study (OMK1 vs. Placebo) A total of 90 patients, 30 per center, will be the study sample. The study will include patients with Primary Open angle Glaucoma (glaucoma or pseudoexfoliation) with a loss of visual field with MD between -2 dB and -15 decibel.
Patients will be randomized into 2 treatment groups, both treated with hypotonic ocular drug therapy: one part of the patients will be treated with the OMK1 Medical Device containing topical citicoline for 3 years; the remaining part will receive a placebo.
All patients will be followed with quarterly visits which will check, in addition to the intraocular pressure (IOP), the structure of the optic nerve and visual function (standard visual field).
The primary objective is to evaluate a reduction of the perimetric progression in the group that receives the topical citicoline compared to the group treated with placebo. The reduction of the progression will be evaluated with Spectral Domain Optic coherence tomography and with standard perimetry (SAP).
The secondary objective is to assess the tolerability and safety of OMK1 eye drops.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Citicoline eye drops (OMK1) | Experimental | 45 patients will be treated with active treatment (OMK1) |
|
| hypromellose based ocular lubricant | Placebo Comparator | 45 patients will be treated with placebo (lubricant eye drops) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Citicoline eye drops (OMK1) | Device | (OMK1) will be prescribed in the dosage of 1 drop 3 times a day |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in glaucomatous damage | The primary objective of the study is to assess whether there is a difference in the deterioration of glaucomatous damage with standard perimetry (HFA 24-2 and 10-2) in the group that receives the topical citicoline in addition to topical therapy with hypotensive drugs compared to the group treated with the sole reduction of intraocular pressure. | Baseline and Visit at 36 months |
| Measure | Description | Time Frame |
|---|---|---|
| progression of glaucoma in the SD OCT examination | assessment of the progression of glaucoma in the SD OCT examination (Retinal Nerve fiber Layer- RNFL evaluation) in the group that receives the topical citicoline together with ocular antihypertensive drug therapy compared to the group treated with the sole reduction of intraocular pressure. It will be used for the assessment of the progression of glaucoma the Brusini staging system. |
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Inclusion Criteria:
Exclusion Criteria:
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| ID | Term |
|---|---|
| D005901 | Glaucoma |
| D005902 | Glaucoma, Open-Angle |
| D017889 | Exfoliation Syndrome |
| ID | Term |
|---|---|
| D009798 | Ocular Hypertension |
| D005128 | Eye Diseases |
| D007499 | Iris Diseases |
| D014603 | Uveal Diseases |
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| Placebo Comparator: hypromellose based ocular lubricant | Other | will be prescribed in the dosage of 1 drop 3 times a day |
|
| Baseline and Visit at 36 months |