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

NCT04020705 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 90

Last updated 2019-07-16

No results posted yet for this study

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

Interventions

DEVICE

Citicoline eye drops (OMK1)

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

OTHER

Placebo Comparator: hypromellose based ocular lubricant

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

Sponsors & Collaborators

  • University of Milan

    collaborator OTHER

  • Istituto di Ricerca Neuroftalmologia S.r.l.

    lead NETWORK

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-09-22
Primary Completion
2019-03-19
Completion
2019-03-19

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04020705 on ClinicalTrials.gov