The purpose of this study is to investigate the safety and efficacy of four concentrations of DE-117 ophthalmic solution.
This is a 28-day randomized, observer-masked, placebo-and active-controlled, parallel-group, multi-center, study investigating the safety and efficacy of four concentrations of DE-117 ophthalmic solution when compared to latanoprost (0.005% latanoprost) and placebo (vehicle of DE-117) in subjects with primary open-angle glaucoma or ocular hypertension.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
91
Unnamed facility
Newport Beach, California, United States
Unnamed facility
Morrow, Georgia, United States
Unnamed facility
Kansas City, Missouri, United States
Unnamed facility
Rochester, New York, United States
Intraocular pressure (mmHg)
Intraocular pressure (mmHg) measurements will be collected at each visit using Goldmann applanation tonometry
Time frame: Day 1, Day 8, Day 15 and Day 29
Adverse events
Adverse events will be assessed at each visit to evaluate safety
Time frame: Day 1, Day 8, Day 15 and Day 29
Ocular signs and symptoms
Ocular symptoms and ocular signs will be collected at each visit using slit lamp biomicroscopy, dilated ophthalmoscopy, gonioscopy, automated perimetry visual field testing, corrected visual acuity and pachymetry
Time frame: Day 1, Day 8, Day 15 and Day 29
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Unnamed facility
Cleveland, Ohio, United States
Unnamed facility
Austin, Texas, United States
Unnamed facility
San Antonio, Texas, United States