The objective of this clinical investigation is to determine the most effective drug concentration(s) of BOL-303259-X in the reduction of IOP in order to support further clinical development of an appropriate dose with regard to efficacy, and ocular and systemic safety.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SCREENING
Masking
SINGLE
Enrollment
413
ophthalmic solution, various concentrations, once daily (QD) 28 days
0.005% ophthalmic solution, QD 28 days
Bausch & Lomb, Inc
Rochester, New York, United States
Change in Mean Diurnal IOP at Visit 6 (Day 28)
Determine the most effective drug concentration(s) of BOL-303259-X in the reduction of intraocular pressure (IOP) and compared to latanoprost
Time frame: Baseline and Visit 6 (Day 28)
Change in Mean Diurnal IOP at Visits 4,5, and 7
Determine the most effective drug concentration(s) of BOL-303259-X in the reduction of intraocular pressure (IOP) and compared to latanoprost
Time frame: Baseline and Visit 4 (Day 7), Visit 5 (day 14), and Visit 7 (Day 29)
IOP </=18mm Hg
Determine the number of subjects with mean diurnal IOP \</=18 mm Hg with BOL-303259-X versus latanoprost ophthalmic solution
Time frame: Visit 4 (Day 7), Visit 5 (day 14), Visit 6 (Day 28) and Visit 7 (Day 29)
Change in IOP at Specified Time Points (8 AM, 12 PM, 4 PM) at Visit 6 (Day 28)
The change in the observed mean study eye IOP from baseline (Visit 3, Day 1) at specified time points (8 AM, 12 PM, 4 PM) at Visit 6 (Day 28)
Time frame: baseline and Visit 6 (Day 28)
Change in IOP at Specified Time Points (8 AM, 12 PM, 4 PM) at Visits 4, 5, and 7 (Days 7, 14, and 29)
The change in the observed mean study eye IOP from baseline (Visit 3, Day 1) at specified time points (points 8 AM, 12 PM, and 4 PM) at Visits 4, 5, and 7 (Days 7, 14, and 29)
Time frame: baseline and Visits 4, 5 and 7 (Days 7, 14, and 29)
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.