The aim of this dose-finding clinical trial is to evaluate the systemic tolerability, local tolerability and intraocular pressure lowering effect of three different doses of SYL040012 in subjects with ocular hypertension or open-angle glaucoma.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
80
East Tallin Central Hospital
Tallinn, Estonia
Eye Clinic Dr. Krista Turman
Tallinn, Estonia
Uniklinik Köln
Cologne, Germany
Universitaetsklinikum Freiburg
Difference in AUC between IOP Curve Obtained at the Established Time Points and the Same Curve Performed at Baseline Period
Time frame: 14 days + (4-7 days)
Simple Corneal and Conjunctival Evaluation
Time frame: 15 days + (3-6 days)
Visual acuity, anterior segment and ocular fundus examination as measures of local tolerability.
Time frame: 14 days + (4-7 days)
Physical exploration and laboratory tests as measurements of general tolerability
Time frame: 14 days + (4-7 days)
Assessment of Adverse Events Appearance
Time frame: 14 days + (4-7 days)
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Freiburg im Breisgau, Germany
Universitaetsklinikum Mainz
Mainz, Germany
Hospital Universitario Ramón y Cajal
Madrid, Madrid, Spain
Clinica Universidad Navarra
Pamplona, Navarre, Spain
Institut Català de Retina
Barcelona, Spain
Hospital Universitario Clínico San Carlos
Madrid, Spain
Hospital Universitario 12 de Octubre
Madrid, Spain
...and 1 more locations