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

NCT ID: NCT04020705

Last Updated: 2019-07-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 90 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-09-22
• Study Completion Date: 2019-03-19

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.

Conditions

Glaucoma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Citicoline eye drops (OMK1)

45 patients will be treated with active treatment (OMK1)

Group Type: EXPERIMENTAL

Citicoline eye drops (OMK1)

Intervention Type: DEVICE

(OMK1) will be prescribed in the dosage of 1 drop 3 times a day

hypromellose based ocular lubricant

45 patients will be treated with placebo (lubricant eye drops)

Group Type: PLACEBO_COMPARATOR

Placebo Comparator: hypromellose based ocular lubricant

Intervention Type: OTHER

will be prescribed in the dosage of 1 drop 3 times a day

Interventions

Citicoline eye drops (OMK1)

(OMK1) will be prescribed in the dosage of 1 drop 3 times a day

Intervention Type: DEVICE

Placebo Comparator: hypromellose based ocular lubricant

will be prescribed in the dosage of 1 drop 3 times a day

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Milan

OTHER

Sponsor Role: collaborator

Istituto di Ricerca Neuroftalmologia S.r.l.

NETWORK

Sponsor Role: lead

Responsible Party

Luca Rossetti

Director Clinical Ophthalmologist P.O. San Paolo Milan

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

OMK20115

Identifier Type: -

Identifier Source: org_study_id