The purpose of this double-masked, randomized, controlled study is to assess the safety and ocular hypotensive efficacy of four different doses of SYL040012 (bamosiran) eye drops compared to Timolol maleate 0.5% after 28 treatment days in patients with elevated intraocular pressure.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
184
Sall Research Medical Center
Artesia, California, United States
North Bay Eye Associates
Petaluma, California, United States
Change From Baseline in the Mean Diurnal IOP Within Each Treatment Arm
Time frame: Baseline and Day 28
Change From Baseline in the Mean Diurnal IOP Within Each Treatment Arm
Time frame: Baseline and Day 14
Change From Baseline in the Glaucoma Quality of Life Questionnaire (GQL-15) Scores Within Each Treatment Arm
The GQL-15 is a 15 item, 4-domain tool. GQL-15 scoring ranges from 0 to 75. Higher scores indicate poorer quality of life.
Time frame: Baseline and Day 29
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Eye Care Centers Management, Inc (Clayton Eye Center)
Morrow, Georgia, United States
Taustin Eye Center
Louisville, Kentucky, United States
East Tallin Central Hospital
Tallinn, Estonia
Eye Clinic Dr. Krista Turman
Tallinn, Estonia
Tartu University Hospital
Tartu, Estonia
Universitaetsklinikum Freiburg
Freiburg im Breisgau, Germany
University Clinic Magdeburg
Magdeburg, Germany
Klinikum der Universität München
München, Germany
...and 11 more locations