An interventional study of Citicoline eye drops (OMK1) and Placebo Comparator: hypromellose based ocular lubricant in Glaucoma, sponsored by Istituto di Ricerca Neuroftalmologia S.r.l.. Completed. Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2019-07-16.
Sponsored by Istituto di Ricerca Neuroftalmologia S.r.l. · Not applicable, Interventional, and Treatment
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.
1,844 studies on the registry are indexed under Glaucoma; 233 are open to participants now.
This study's enrollment of 90 is above the median of 65 across 1,296 interventional studies indexed under Glaucoma.
Browse Glaucoma studies →Istituto di Ricerca Neuroftalmologia S.r.l. is the lead sponsor of 2 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
45 patients will be treated with active treatment (OMK1)
Device: Citicoline eye drops (OMK1)
45 patients will be treated with placebo (lubricant eye drops)
Other: Placebo Comparator: hypromellose based ocular lubricant
(OMK1) will be prescribed in the dosage of 1 drop 3 times a day
will be prescribed in the dosage of 1 drop 3 times a day
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.
Time frame: Baseline and Visit at 36 months
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.
Time frame: Baseline and Visit at 36 months
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
Ran from Sep 2015 to primary completion in Mar 2019, 41 months.
Of 272 non-industry interventional studies with no phase under Glaucoma, half reached primary completion within 30 months of starting (the median), counting those still running; a quarter within 14 and three quarters within 55. This study's 41 months is above that.
Counting every sponsor, half of 355 studies reached it within 29 months; a quarter within 15 and three quarters within 55.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jul 2019. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Istituto di Ricerca Neuroftalmologia S.r.l.