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

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.

Study Overview

• Status: Completed
• Conditions: Glaucoma
• Intervention / Treatment: Device: Citicoline eye drops (OMK1); Other: Placebo Comparator: hypromellose based ocular lubricant

• Study Type: Interventional
• Enrollment (Actual): 90
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Citicoline eye drops (OMK1); 45 patients will be treated with active treatment (OMK1)	Device: Citicoline eye drops (OMK1); (OMK1) will be prescribed in the dosage of 1 drop 3 times a day
Placebo Comparator: hypromellose based ocular lubricant; 45 patients will be treated with placebo (lubricant eye drops)	Other: Placebo Comparator: hypromellose based ocular lubricant; will be prescribed in the dosage of 1 drop 3 times a day

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Baseline and Visit at 36 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Baseline and Visit at 36 months

Collaborators and Investigators

• Sponsor: Istituto di Ricerca Neuroftalmologia S.r.l.
• Collaborators: University of Milan

Study record dates

Study Major Dates

• Study Start (Actual): September 22, 2015
• Primary Completion (Actual): March 19, 2019
• Study Completion (Actual): March 19, 2019

Study Registration Dates

• First Submitted: April 12, 2019
• First Submitted That Met QC Criteria: July 15, 2019
• First Posted (Actual): July 16, 2019

Study Record Updates

• Last Update Posted (Actual): July 16, 2019
• Last Update Submitted That Met QC Criteria: July 15, 2019
• Last Verified: July 1, 2019

More Information

Terms related to this study

• Keywords: Glaucoma; Glaucoma Open Angle; Pseudoexfoliation Glaucoma
• Additional Relevant MeSH Terms: Eye Diseases; Ocular Hypertension; Glaucoma; Pharmaceutical Solutions; Nootropic Agents; Ophthalmic Solutions; Cytidine Diphosphate Choline
• Other Study ID Numbers: OMK20115

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No