Treatment of elevated pressure in the eye (Intraocular pressure, or 'IOP') with eye drop medications has been shown to be effective in delaying or preventing the progression of glaucoma, and it is the only proven method for reducing the risk of glaucomatous visual field loss. This study is being conducted to determine how well DE-126 ophthalmic solution works (efficacy) in safely lowering IOP when dosed as topical eyedrops. This study will evaluate the safety and efficacy of four (4) concentrations of DE-126, when compared with latanoprost (0.005%) eye drops in patients with primary open-angle glaucoma or ocular hypertension. The IOP will be measured at 3 different times throughout the day, over 6 total visits during a 3-month treatment period (with up to 4 extra weeks observation if the patient must stop taking current eye drops to lower IOP). Safety assessments will be done throughout the study, including ocular signs and symptoms, vital signs, and clinical laboratory tests. While the most important time-point to measure IOP in this study and evaluate efficacy will be at the final study visit (month 3), IOP values will also be evaluated at other visits throughout the 3-month treatment period.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
241
Vehicle of DE-126 Ophthalmic Solution dosed once daily for 6weeks, followed by high dose of DE-126 dosed once daily for 6 additional weeks
Topical ultra-low dose of DE-126 Ophthalmic Solution dosed once daily for 12 weeks
Topical low dose of DE-126 Ophthalmic Solution dosed once daily for 12 weeks
Topical medium dose of DE-126 Ophthalmic Solution dosed once daily for 12 weeks
Topical high dose of DE-126 Ophthalmic Solution dosed once daily for 12 weeks
0.005% Latanoprost Ophthalmic Solution dosed once daily for 12 weeks
Sall Research Medical Center, Inc
Artesia, California, United States
North Valley Eye Medical Group
Mission Hills, California, United States
Eye Research Foundation, INC
Newport Beach, California, United States
North Bay Eye Associates, Inc.
Petaluma, California, United States
Shettle Eye Research, Inc.
Largo, Florida, United States
Clayton Eye Clinical Research, LLC
Morrow, Georgia, United States
Coastal Research Associates, LLC
Roswell, Georgia, United States
Rochester Ophthalmological Group, PC
Rochester, New York, United States
Mundorf Eye Center
Charlotte, North Carolina, United States
Cornerstone Health Care, LLC
High Point, North Carolina, United States
...and 7 more locations
Intraocular Pressure in the Study Eye at Month 3
Intraocular Pressure (IOP),the fluid pressure inside the eye was measured by the Goldmann applanation tonometer in millimeters mercury (mmHg) at 3 time-points throughout the day.
Time frame: 9:00, 13:00 and 17:00 at Month 3
Intraocular Pressure in the Study Eye at Week 6
Intraocular Pressure (IOP),the fluid pressure inside the eye was measured by the Goldmann applanation tonometer in millimeters mercury (mmHg) at 3 time-points throughout the day.
Time frame: 9:00, 13:00 and 17:00 at Week 6
Intraocular Pressure in the Study Eye at Week 1 and Week 2
Intraocular Pressure (IOP),the fluid pressure inside the eye was measured by the Goldmann applanation tonometer in millimeters mercury (mmHg) at 3 time-points throughout the day.
Time frame: 9:00, 13:00 and 17:00 at Week 1 and Week 2
Mean Diurnal Intraocular Pressure in the Study Eye at Each Post-baseline Visit
Mean Diurnal IOP was defined as the mean of the IOP values at the three schedules timepoints (9:00, 13:00 and 17:00) at that visit for that subject.
Time frame: Week 1, Week 2, Week 6 and Month 3.
Change From Baseline (CFB) in Mean Diurnal Intraocular Pressure in the Study Eye at Each Post-baseline Visit
Mean Diurnal IOP was defined as the mean of the IOP values at the three schedules timepoints (9:00, 13:00 and 17:00) at that visit for that subject.
Time frame: Week 1, Week 2, Week 6 and Month 3.
Percent Change From Baseline (CFB) in Mean Diurnal Intraocular Pressure in the Study Eye at Each Post-baseline Visit
Mean Diurnal IOP was defined as the mean of the IOP values at the three schedules timepoints (9:00, 13:00 and 17:00) at that visit for that subject.
Time frame: Week 1, Week 2, Week 6 and Month 3.
Change From Baseline (CFB) in Intraocular Pressure in the Study Eye at Three Time Points at Each Post-baseline Visit
Intraocular Pressure (IOP),the fluid pressure inside the eye was measured by the Goldmann applanation tonometer in millimeters mercury (mmHg) at 3 time-points throughout the day.
Time frame: 9:00, 13:00 and 17:00 at Week 1, Week 2, Week 6 and Month 3.
Percent Change From Baseline (CFB) in Intraocular Pressure in the Study Eye at Three Time Points at Each Post-baseline Visit
Intraocular Pressure (IOP),the fluid pressure inside the eye was measured by the Goldmann applanation tonometer in millimeters mercury (mmHg) at 3 time-points throughout the day.
Time frame: 9:00, 13:00 and 17:00 at Week 1, Week 2, Week 6 and Month 3.
Percentage of Subjects With Mean Diurnal Intraocular Pressure Reduction From Baseline ≥ 20%, 25% and 30% in the Study Eye at Each Post-baseline Visit
A Subject was a responder if the percent reduction from baseline in mean diurnal IOP in the study eye was ≥ 20%. A Subject was a responder if the percent reduction from baseline in mean diurnal IOP in the study eye was ≥ 25%. A Subject was a responder if the percent reduction from baseline in mean diurnal IOP in the study eye was ≥ 30%.
Time frame: WeeK 1, Week 2, Week 6 and Month 3.
Percentage of Subjects With Mean Diurnal Intraocular Pressure ≤ 18 mmHg in the Study Eye at Each Post-baseline Visit
A subject was a responder if the mean diurnal IOP in the study eye was ≤ 18 mmHg.
Time frame: Week 1, Week 2, Week 6 and Month 3.
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