A study to assess efficacy of citicoline on visual field preservation in patients with glaucoma
- Conditions
- GlaucomaMedDRA version: 20.0Level: PTClassification code: 10035015Term: Pigmentary glaucoma Class: 100000004853MedDRA version: 20.0Level: LLTClassification code: 10036719Term: Primary open angle glaucoma Class: 10015919MedDRA version: 20.0Level: LLTClassification code: 10037118Term: Pseudoexfoliation glaucoma Class: 10015919Therapeutic area: Diseases [C] - Eye Diseases [C11]
- Registration Number
- CTIS2022-502273-42-00
- Lead Sponsor
- Omikron Italia S.r.l.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 1000
1.Signed written informed consent. 2.Age = 18 years. 3.Eyes with OAG, Pseudoexfoliation and pigmentary glaucoma will be included. 4.Best Corrected Visual Acuity (BCVA) = 0.5 for the study eye. 5.Controlled IOP (= 18 mmHg, average of the last 3 measurements in the clinic) in the study eye. 6.Visual field MD not worse than -12 dB at the latest assessment in the clinic for the study eye. 7.Glaucoma definition will be based on VF damage (24-2, any SITA strategy) and spatially congruent glaucomatous changes at the ONH. If both eyes are eligible, the eye with the better MD will be chosen as the study eye. Please refer to the following definitions: • OAG: a reproducible glaucomatous VF defect in at least one eye in reliable VFs (false positive rate =15%) with corresponding glaucomatous damage to the Optic Nerve Head (ONH), with an open angle on gonioscopy and in the absence of a retinal, neurological or adnexal condition that could account for the VF loss. • Glaucomatous damage to the Optic Nerve Head: focal or diffuse loss of neuro-retinal tissue identified by the investigator by means of ophthalmoscopy AND/OR fundus photographs AND/OR Optical Coherence Tomography imaging. • Reproducible glaucomatous VF defect: a Glaucoma Hemifield Test (GHT) outside normal limits AND a cluster of 3 or more locations, 2 of which are depressed on the pattern deviation plot at a P value of <5% and 1 of which is depressed at a P value of <1%, on at least 2 consecutive reliable fields. At least 1 common location in the cluster should be depressed at <5% in the 2 consecutive VFs. • Definition of a VF cluster: each depressed location in the clusters should be adjacent to at least one other depressed location. 8.Women of childbearing potential (WOCBP) willing to use a highly effective method of contraception for up to 90 days after the last dose of treatment.
1.Cataract in the study eye which, in the opinion of the clinician, may require cataract surgery within the next three years. 2.Only-eye patients (visual acuity < 0.1 decimals in one eye or more than two paracentral VF locations with a sensitivity of < 10 dB). 3.Known intolerance or allergy to any of the components in the eye drops. 4.Diode laser treatment or glaucoma surgery in the past 2 years or cataract surgery within the last 6 months in the study eye. 5.Eyes with any type of glaucoma other than primary, pseudoexfoliative or pigmentary OAG. 6.Patients with other ocular or systemic comorbidities that, in the opinion of the Investigator, might affect the VF or the execution of the test. 7.Patients already on topical or systemic citicoline treatment. 8.Patients taking other systemic or topical potential neuroprotectors used in glaucoma, i.e., citicoline (CDP-choline), choline and derivatives, coenzyme Q10, vitamin B3 / niacin/ nicotinamide/ nicotinamide riboside chloride /nicotinic acid, ginkgo biloba, and unwilling to suspend these treatments and undergo a washout period of 6 months prior to the study 9.Patients unable to perform reliable VF tests, based on the assessment of the last 4 available 24-2 Humphrey Field Analyzer (HFA) VF tests performed in the clinic with a false positive rate (FP) = 15%. 10.Although effects on the human fetus are considered unlikely, these effects are still unknow and the safety of citicoline for use during pregnancy has not been established. Therefore, pregnant and nursing women will be excluded from the study.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: Determining whether citicoline eye drops 2% are superior to placebo in reducing VF deterioration in patients with progressing open angle glaucoma (OAG) treated according to best clinical practice.;Secondary Objective: Evaluation of the effect of citicoline eye drops 2% on changes in structural parameters and the confirmation of the safety profile of citicoline eye drops 2%;Primary end point(s): rate of change in MD in the study eye, an index of the global deviation of the age-corrected normal values. The objective is to assess the difference in the rate of progression over 3 years of study in the experimental arm compared to the control arm
- Secondary Outcome Measures
Name Time Method Secondary end point(s):To establish differences in the rate of change of structural thickness (peripapillary Retinal Nerve Fibre Layer (RNFL) with Optical Coherence Tomography – OCT) and macular thickness of the inner retina (RNFL, Ganglion Cell Layer and Ganglion Cell + Inner Plexiform Layer complex evaluated by SD-OCT)