The trial will evaluate the safety and efficacy of 3 dose regimens of H-1337 \[0.6% twice daily (b.i.d.), 1.0% b.i.d. and 1.0% once in the morning (q.a.m.), and timolol maleate (0.5%, b.i.d.) in both eyes for 28 days.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
201
ophthalmic solution
ophthalmic solution
ophthalmic solution
Global Research Management
Glendale, California, United States
Skyline Vision Clinic and Laser Center
Colorado Springs, Colorado, United States
Central Florida Eye Associates
Lakeland, Florida, United States
Shettle Eye Research, Inc.
Efficacy as Assessed by Change in Intraocular Pressure
Mean change in intraocular pressure from baseline on Day 28 compared to timolol
Time frame: Day 28
Efficacy as Assessed by Intraocular Pressure
Percentage of subjects reaching target intraocular pressure (≤18 mmHg) at each time point
Time frame: Day 0, Day 1, Day 7, Day 14, and Day 28
Safety as Assessed by Adverse Event Reporting
Percentage of participants with ocular and systemic adverse events
Time frame: Screening through Day 28
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ophthalmic solution
Largo, Florida, United States
Dixon Eye Care
Albany, Georgia, United States
Coastal Research Associates, LLC
Roswell, Georgia, United States
Rochester Ophthalmological Group, PC
Rochester, New York, United States
University Eye Specialists
Maryville, Tennessee, United States
Vistar Eye Center
Roanoke, Virginia, United States