Status:
COMPLETED
Study of Neurotidine® Intake on Life Quality of Patients With Glaucoma
Lead Sponsor:
Omikron Italia S.r.l.
Conditions:
Glaucoma
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The purpose for the study consists in the assessment of the role of Neurotidine® (citicoline oral solution) on the dopaminergic pathway and particularly its potential implications on psychophysical pe...
Detailed Description
Primary open angle glaucoma is a chronic progressive neurodegenerative disease and the only proven effective therapy involves reduction of intraocular pressure (IOP). Although treatment effect is quit...
Eligibility Criteria
Inclusion
- Patients must meet all the following criteria to be eligible for the study:
- Signed written informed consent.
- Age ≥ 18 years.
- Patients with bilateral open-angle glaucoma (OAG). PEX and pigmentary glaucoma will be included.
- Controlled IOP
- Patients with moderate damage in the better eye, with mean deviation from normal value (MD) ranging from -6 to -12 dB in the 6 months prior to enrollment. At the screening assessment, MD must range from -5 to -13 dB.
- Glaucoma definition will be based on visual field (VF) damage (24-2, SITA standard strategy) corresponding to glaucomatous changes at the optic nerve head. Values of IOP will not be an inclusion criterion, though a "controlled IOP" based on the clinician's judgement will be required.
Exclusion
- Patients must meet none of the following criteria to be eligible for the study:
- Single-eyed patients (visual acuity \<0.1 in one eye).
- Patients without the psychophysical requirements to adequately participate and complete the trial.
- Patients with chronic angle-closure glaucoma (CACG) or other types of glaucoma.
- Patients with other ocular comorbidities interfering with the correct assessment of the glaucomatous damage to the VF.
- Patients who have undergone surgery within 6 months.
- Patients taking other potential neuroprotectors, including topical, competing with Neurotidine®.
- Patients with Parkinson's disease, dementia or a diagnosis of stroke in the last 6 months.
Key Trial Info
Start Date :
February 13 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 24 2022
Estimated Enrollment :
155 Patients enrolled
Trial Details
Trial ID
NCT04046809
Start Date
February 13 2019
End Date
January 24 2022
Last Update
April 29 2022
Active Locations (5)
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1
University Hospitals Leuven
Leuven, Belgium
2
Aristotle University of Thessaloniki AHEPA Hospital Thessaloniki
Thessaloniki, Greece
3
Presidio Ospedale San Paolo
Milan, MI, Italy, 20142
4
Fondazione PTV Policlinico Tor Vergata
Roma, Italy, 00133