In this double-masked, vehicle-controlled, dose-response study, subjects will be randomized to receive AR-13324 Ophthalmic Solution 0.01%, 0.02%, and 0.04% or its vehicle (one eye), once daily (QD)in the morning (AM) for 7 days. The first dose and last dose will be administered in the clinic. Ocular safety and ocular hypotensive efficacy will be evaluated in the clinic throughout the study.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
85
Administered to study eye, once daily (QD) in the morning (AM) for 7 days
Administered to study eye, QD AM for 7 days
Administered to study eye, QD AM for 7 days
Aesthetic Eye Care Institute
Newport Beach, California, United States
Robert Noecker, M.D., M.B.A.
Fairfield, Connecticut, United States
Coastal Research Associates, LLC
Roswell, Georgia, United States
Intraocular Pressure (IOP)
The primary efficacy outcome was the mean IOP across subjects within treatment group at each post-treatment timepoint of Day 8. Instillation of study treatment commenced on Day 2 following measurement of IOP. IOP was measured at 0800, 1000, 1200 and 1600 hours on days 2 and 8. IOP was also measured at 0800 hours on Day 4.
Time frame: Study treatment was administered for 7 days; starting on Day 2 and ending on Day 8.
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Administered to study eye, QD AM for 7 days
Heart of America Eye Care, P.A.
Shawnee Mission, Kansas, United States
Comprehensive Eye Care
St Louis, Missouri, United States
Rochester Ophthalmology Group
Rochester, New York, United States
The Eye Institute
Tulsa, Oklahoma, United States
Wills Eye Hospital
Philadelphia, Pennsylvania, United States
Univ Eye Surgeons, Maryville Ctr.
Maryville, Tennessee, United States
Texan Eye
Austin, Texas, United States
...and 1 more locations