The purpose of the study is to assess the safety, tolerability, and IOP effects of RO5093151 following 7 days of topical ocular treatment in patients with primary open angle glaucoma or ocular hypertension.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
45
Latanoprost is a ophthalmic solution, available in dose strength as 0.005%.
Matching placebo formulation will be administered in Part A.
RO5093151 is a ophthalmic solution, available in dose strengths as 0.1%, 0.5% and 1%.
Sall Research Medical Center
Artesia, California, United States
Rocky Mountain Lions Eye Inst
Aurora, Colorado, United States
Eye Care Centers Management, Inc. (Clayton Eye Center)
Morrow, Georgia, United States
New York Eye and Ear Infirmary of Mt. Sinai; New York Glaucoma Research Institute
Incidence of adverse events
Time frame: Up to 12 weeks
Changes in vital signs, electrocardiogram (ECG), opthalmologic assessments, and clinical laboratory results
Time frame: Up to 12 weeks
Change in mean IOP after 7 days treatment vs baseline: change from baseline for RO5093151 and latanoprost and difference in change from baseline between RO5093151 and latanoprost
Time frame: Baseline (Day 1) and Day 8
Change in IOP at matched clock-times after 7 days of treatment vs baseline (diurnal IOP) and between RO5093151 and latanoprost
Time frame: Baseline and Day 8
Maximum observed plasma concentration (Cmax)
Time frame: Day 1: Pre-dose (morning); 30 minutes, 1, 4, 8, 11 (evening pre-dose) and 12 hours post-dose; Day 7: Pre-dose (evening), 1, 12 (Day 8), 16 (Day 8), 20 (Day 8) hours post-dose
Time to maximum observed plasma concentration (Tmax)
Time frame: Day 1: Pre-dose (morning); 30 minutes, 1, 4, 8, 11 (evening pre-dose) and 12 hours post-dose; Day 7: Pre-dose (evening), 1, 12 (Day 8), 16 (Day 8), 20 (Day 8) hours post-dose
Concentration at the end of a dosing interval before the next dose administration (Ctrough)
Time frame: Day 1: Pre-dose (morning); 30 minutes, 1, 4, 8, 11 (evening pre-dose) and 12 hours post-dose; Day 7: Pre-dose (evening), 1, 12 (Day 8), 16 (Day 8), 20 (Day 8) hours post-dose
Area under the plasma concentration versus time curve from zero to 24 h post-dose (AUC0-24)
Time frame: Day 1: Pre-dose (morning); 30 minutes, 1, 4, 8, 11 (evening pre-dose) and 12 hours post-dose; Day 7: Pre-dose (evening), 1, 12 (Day 8), 16 (Day 8), 20 (Day 8) hours post-dose
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New York, New York, United States
Cornerstone Eye Care, Div of Cornerstone Health Care
High Point, North Carolina, United States
West Virginia University Eye Institute
Morgantown, West Virginia, United States
Singapore National Eye Centre; Glaucoma Department
Singapore, Singapore
Area under the plasma concentration versus time curve up to the last measurable concentration (AUClast)
Time frame: Day 1: Pre-dose (morning); 30 minutes, 1, 4, 8, 11 (evening pre-dose) and 12 hours post-dose; Day 7: Pre-dose (evening), 1, 12 (Day 8), 16 (Day 8), 20 (Day 8) hours post-dose
Apparent terminal half-life (T1/2)
Time frame: Day 1: Pre-dose (morning); 30 minutes, 1, 4, 8, 11 (evening pre-dose) and 12 hours post-dose; Day 7: Pre-dose (evening), 1, 12 (Day 8), 16 (Day 8), 20 (Day 8) hours post-dose