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The Efficacy of Citicoline in Eyedrops (OMK1) in Reducing the Progression of Glaucoma

Glaucoma Clinical Trial

Official title:
The Efficacy of Citicoline in Eyedrops (OMK1) in Reducing the Progression of Glaucoma

Clinical Trial Summary

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.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04020705
Study type Interventional
Source Istituto di Ricerca Neuroftalmologia S.r.l.
Contact
Status Completed
Phase N/A
Start date September 22, 2015
Completion date March 19, 2019
View Details
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