Clinical trial NCT04020705: The Efficacy of Citicoline in Eyedrops (OMK1) in Reducing the Progression of Glaucoma
Official title: The Efficacy of Citicoline in Eyedrops (OMK1) in Reducing the Progression of Glaucoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Glaucoma
Keywords: Glaucoma
Glaucoma Open Angle
Pseudoexfoliation Glaucoma
Lead sponsor: Istituto di Ricerca Neuroftalmologia S.r.l.
Sponsor class: NETWORK
Collaborators: name: University of Milan
First posted: 2019-07-16
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: Inclusion Criteria:

* Patients with POAG and pseudoexfoliation glaucoma in one or both eyes. In the latter case, only one eye (chosen at random) will be used for the analysis.
* Patients with -2 \< MD \< -15 dB, progression of MD at least -0,5 dB/y for 2 years.
* Patients with tonometric compensation, i.e., IOP not above 18 mmHg. Tonometric compensation can be achieved with any type of hypotonic medical therapy and must be maintained during the 3 years of the study. If at any check-up the average of at least 3 measurements of IOP at different times is higher than 18 mmHg, the patient will be offered a new hypotonic treatment (including surgery) to control the progression of the disease. If compensation cannot be achieved (e.g., the patient refuses the proposed therapy or, in spite of this does not achieve satisfactory IOP values), the patient will be excluded from the study.
* Patients over the age of 18 years

Exclusion Criteria:

* Patients with contraindications to citicoline
* Patients with IOP higher than 18 mmHg
* Patients with other forms of glaucoma
* Patients treated with other neuroprotective therapies
* Women who are pregnant and/or breastfeeding
* Pediatric or adolescent patients aged under 18 years

Primary outcomes:
measure: Change in glaucomatous damage
timeFrame: Baseline and Visit at 36 months
Secondary outcomes:
measure: progression of glaucoma in the SD OCT examination
timeFrame: Baseline and Visit at 36 months
Other outcomes:
Locations:
Study officials:
References: