Status:
COMPLETED
The Efficacy of Citicoline in Eyedrops (OMK1) in Reducing the Progression of Glaucoma
Lead Sponsor:
Istituto di Ricerca Neuroftalmologia S.r.l.
Collaborating Sponsors:
University of Milan
Conditions:
Glaucoma
Eligibility:
All Genders
18-90 years
Phase:
NA
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) ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 22 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 19 2019
Estimated Enrollment :
90 Patients enrolled
Trial Details
Trial ID
NCT04020705
Start Date
September 22 2015
End Date
March 19 2019
Last Update
July 16 2019
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