A Phase IIb Safety and Efficacy Study of DE-126 Ophthalmic Solution in Primary Open-Angle Glaucoma or Ocular Hypertension- Angel Study
- Conditions
- Open-angle Glaucoma, Ocular Hypertension
- Interventions
- Drug: Vehicle of DE-126 Ophthalmic Solution, high dose of DE-126 Ophthalmic SolutionDrug: Topical ultra-low dose of DE-126 Ophthalmic SolutionDrug: Topical low dose of DE-126 Ophthalmic SolutionDrug: Topical medium dose of DE-126 Ophthalmic SolutionDrug: Topical high dose of DE-126 Ophthalmic Solution
- Registration Number
- NCT03216902
- Lead Sponsor
- Santen Inc.
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 241
- Provide signed written informed consent
- Diagnosis of POAG or OHT in both eyes
- Qualifying corrected visual acuity in each eye
- Qualifying central corneal thickness in each eye
- Qualifying Day 1 IOP measurement at 3 time-points in both eyes
- Qualifying Anterior chamber angle
- History of ocular surgery specifically intended to lower IOP
- Subjects who cannot safely discontinue use of ocular hypotensive medications during the wait/washout period
- Advanced glaucoma in either eye
- Any corneal abnormality or other condition interfering with or preventing reliable Goldmann applanation tonometry
- Any ocular surgery or ocular laser treatment within 90 days prior to Visit 1 (Screening) and throughout the study in either eye
- Females who are pregnant, nursing, or planning a pregnancy
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo (Vehicle of DE-126) followed by high dose of DE-126 Vehicle of DE-126 Ophthalmic Solution, high dose of DE-126 Ophthalmic Solution - Ultra-low dose 0.0005% DE-126 Topical ultra-low dose of DE-126 Ophthalmic Solution - Low dose 0.001% DE-126 Topical low dose of DE-126 Ophthalmic Solution - Medium dose 0.002% DE-126 Topical medium dose of DE-126 Ophthalmic Solution - High dose 0.003% DE-126 Topical high dose of DE-126 Ophthalmic Solution - 0.005% Latanoprost 0.005% Latanoprost Ophthalmic Solution -
- Primary Outcome Measures
Name Time Method Intraocular Pressure in the Study Eye at Month 3 9:00, 13:00 and 17:00 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.
- Secondary Outcome Measures
Name Time Method Intraocular Pressure in the Study Eye at Week 6 9:00, 13:00 and 17:00 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.
Intraocular Pressure in the Study Eye at Week 1 and Week 2 9:00, 13:00 and 17:00 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.
Mean Diurnal Intraocular Pressure in the Study Eye at Each Post-baseline Visit Week 1, Week 2, Week 6 and Month 3. 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.
Change From Baseline (CFB) in Mean Diurnal Intraocular Pressure in the Study Eye at Each Post-baseline Visit Week 1, Week 2, Week 6 and Month 3. 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.
Percent Change From Baseline (CFB) in Mean Diurnal Intraocular Pressure in the Study Eye at Each Post-baseline Visit Week 1, Week 2, Week 6 and Month 3. 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.
Change From Baseline (CFB) in Intraocular Pressure in the Study Eye at Three Time Points at Each Post-baseline Visit 9:00, 13:00 and 17:00 at Week 1, Week 2, Week 6 and 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.
Percent Change From Baseline (CFB) in Intraocular Pressure in the Study Eye at Three Time Points at Each Post-baseline Visit 9:00, 13:00 and 17:00 at Week 1, Week 2, Week 6 and 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.
Percentage of Subjects With Mean Diurnal Intraocular Pressure Reduction From Baseline ≥ 20%, 25% and 30% in the Study Eye at Each Post-baseline Visit WeeK 1, Week 2, Week 6 and Month 3. 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%.Percentage of Subjects With Mean Diurnal Intraocular Pressure ≤ 18 mmHg in the Study Eye at Each Post-baseline Visit Week 1, Week 2, Week 6 and Month 3. A subject was a responder if the mean diurnal IOP in the study eye was ≤ 18 mmHg.
Trial Locations
- Locations (17)
Cornerstone Health Care, LLC
🇺🇸High Point, North Carolina, United States
Coastal Research Associates, LLC
🇺🇸Roswell, Georgia, United States
Sapporo Katoh Ophthalmology Clinic
🇯🇵Sapporo-shi, Hokkaido, Japan
Dogenzaka Kato Eye Clinic
🇯🇵Shibuya-ku, Tokyo, Japan
Clayton Eye Clinical Research, LLC
🇺🇸Morrow, Georgia, United States
Nagasaka Eye Clinic
🇯🇵Nagoya-shi, Aichi, Japan
Murakami Karindoh Hospital
🇯🇵Fukuoka-shi, Fukuoka, Japan
Sugiura Eye Clinic
🇯🇵Osaka-shi, Osaka, Japan
North Valley Eye Medical Group
🇺🇸Mission Hills, California, United States
Mundorf Eye Center
🇺🇸Charlotte, North Carolina, United States
Shettle Eye Research, Inc.
🇺🇸Largo, Florida, United States
North Bay Eye Associates, Inc.
🇺🇸Petaluma, California, United States
Rochester Ophthalmological Group, PC
🇺🇸Rochester, New York, United States
Sall Research Medical Center, Inc
🇺🇸Artesia, California, United States
Keystone Research Ltd SMO/Texan Eye, PA
🇺🇸Austin, Texas, United States
Eye Research Foundation, INC
🇺🇸Newport Beach, California, United States
Keystone Research LTD SMO/Medical Center Ophthalmology Assoc.
🇺🇸San Antonio, Texas, United States