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This is a randomized, double blind study with competitive enrolment, aimed to enroll a total of 70 patients with a diagnosis of primary open angle glaucoma (POAG).
Patients, after signing the Informed Consent, will enter into a 1- week screening phase during which the baseline tests will be conducted.
Subjects will be randomized in a 1:1 ratio to the following groups:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| group A | Placebo Comparator | 35 patients treated with pressure lowering drugs and placebo |
|
| group B | Experimental | 35 patients with pressure lowering drugs and COQUN oral formulation 100 mg BID. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CoQ10- MINIACTIVES | Dietary Supplement | COQUN oral formulation 100 mg BID |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Pattern Electroretinogram Amplitude (PERG P50-N95 A) | To evaluate the difference of mean changes of Pattern Electroretinogram Amplitude (PERG P50-N95 A) (μV) observed between the two study groups. | between the baseline visit (V0) and the last study visit after 12 months of treatment (V3) |
| Measure | Description | Time Frame |
|---|---|---|
| Pattern Electroretinogram Amplitude (PERG P50-N95 A) | To evaluate the difference of mean changes of Pattern Electroretinogram Amplitude (PERG P50-N95 A) (μV) observed between the two study groups. | between the baseline visit (V0) and Month 4 and Month 8 and the last study visit after 12 months of treatment (V3) |
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Inclusion criteria:
Exclusion criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Stanislao Rizzo | Contact | +39 06 301 54 929 | stanislao.rizzo@policlinicogemelli.it |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UO Oculistica - PO Cisanello | Recruiting | Pisa | PI | 56124 | Italy |
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| ID | Term |
|---|---|
| D005902 | Glaucoma, Open-Angle |
| ID | Term |
|---|---|
| D005901 | Glaucoma |
| D009798 | Ocular Hypertension |
| D005128 | Eye Diseases |
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| Placebo |
| Dietary Supplement |
Placebo |
|
| Pattern Electroretinogram Amplitude Implicit Times (PERG P50 IT) |
To evaluate the changes from baseline to each study visit between the two study groups in Pattern Electroretinogram Amplitude Implicit Times (PERG P50 IT) in milliseconds (ms) |
| between the baseline visit (V0) and Month 4 and Month 8 and the last study visit after 12 months of treatment (V3) |
| Visual Evoked Potentials Implicit Times (VEP P100 IT) | To evaluate the changes from baseline to each study visit between the two study groups in Visual Evoked Potentials Implicit Times (VEP P100 IT) in milliseconds (ms) | between the baseline visit (V0) and Month 4 and Month 8 and the last study visit after 12 months of treatment (V3) |
| Visual Evoked Potentials Amplitude (VEP N75-P100 A) | To evaluate the changes from baseline to each study visit between the two study groups in Visual Evoked Potentials Amplitude (VEP N75-P100 A) in microvolt (μV) | between the baseline visit (V0) and Month 4 and Month 8 and the last study visit after 12 months of treatment (V3) |
| Visual field | To evaluate the changes from baseline to each study visit between the two study groups in Visual field (separately MD and PSD) evaluated by Humphrey field analyzer (HFA) Sita Standard 30-2 | from baseline to each study visit (V1, V2, V3) |
| Contrast sensitivity | To evaluate the changes from baseline to each study visit between the two study groups in Contrast sensitivity measured with Vistech tables (Vision Chart from CSO) | between the baseline visit (V0) and Month 4 and Month 8 and the last study visit after 12 months of treatment (V3) |
| Optical Coherence Tomography | To evaluate the changes from baseline to each study visit between the two study groups in Peripapillary retinal nerve fiber layer (RNFL) thickness, macular RNFL, macular ganglion cell layer (GCL), macular inner plexiform layer (IPL) assessed with natural pupils by the means of spectral domain Optical Coherence Tomography (OCT, Heidelberg Spectralis) | between the baseline visit (V0) and Month 4 and Month 8 and the last study visit after 12 months of treatment (V3) |
| U.O. di Oculistica, Fondazione Policlinico Agostino A. Gemelli, | Recruiting | Rome | Italy |
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