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

NCT04020705 | Completed DMC

• 1 other identifier: OMK20115
• Study Type: interventional
• Target: 90
• Locations: 0 countries
• Sites: N/A

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

Keywords

Glaucoma; Glaucoma Open Angle; Pseudoexfoliation Glaucoma

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• progression of glaucoma in the SD OCT examination

  Baseline and Visit at 36 months

Study Arms (2)

Citicoline eye drops (OMK1)

EXPERIMENTAL

45 patients will be treated with active treatment (OMK1)

Device: Citicoline eye drops (OMK1)

hypromellose based ocular lubricant

PLACEBO COMPARATOR

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

Other: Placebo Comparator: hypromellose based ocular lubricant

Interventions

Citicoline eye drops (OMK1) DEVICE

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

Citicoline eye drops (OMK1)

Placebo Comparator: hypromellose based ocular lubricant OTHER

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

hypromellose based ocular lubricant

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Istituto di Ricerca Neuroftalmologia S.r.l.: lead
• University of Milan: collaborator

MeSH Terms

Conditions

Glaucoma; Glaucoma, Open-Angle; Exfoliation Syndrome

Condition Hierarchy (Ancestors)

Ocular Hypertension; Eye Diseases; Iris Diseases; Uveal Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director Clinical Ophthalmologist P.O. San Paolo Milan

Study Record Dates

• First Submitted: April 12, 2019
• First Posted: July 16, 2019
• Study Start: September 22, 2015
• Primary Completion: March 19, 2019
• Study Completion: March 19, 2019
• Last Updated: July 16, 2019

Record last verified: 2019-07

Data Sharing

• IPD Sharing: Will not share