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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04020705
Other study ID # OMK20115
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date September 22, 2015
Est. completion date March 19, 2019

Study information

Verified date July 2019
Source Istituto di Ricerca Neuroftalmologia S.r.l.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 90
Est. completion date March 19, 2019
Est. primary completion date March 19, 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years to 90 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
n/a

Sponsors (2)

Lead Sponsor Collaborator
Istituto di Ricerca Neuroftalmologia S.r.l. University of Milan

Outcome

Type Measure Description Time frame Safety issue
Primary 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 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
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