Multicenter Study Assessing the Efficacy and Safety of DE-126 Ophthalmic Solution 0.002% Compared With Timolol Maleate Ophthalmic Solution 0.5% in Subjects With Primary Open Angle Glaucoma or Ocular Hypertension
- Conditions
- Ocular HypertensionPrimary Open Angle Glaucoma
- Interventions
- Drug: DE-126 Ophthalmic Solution 0.002% QD
- Registration Number
- NCT04742283
- Lead Sponsor
- Santen Inc.
- Brief Summary
Reduction 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 DE-126, ophthalmic solution in subjects with Primary Open Angle Glaucoma (POAG) or Ocular Hypertension (OHT).
The IOP will be measured at 3 different times throughout the day, over 4 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, and vital signs. 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
- 323
- Have been diagnosed of POAG or OHT in both eyes, or one eye with OAG and other with OHT
- Completed the required wait/washout period
- Qualifying Day 1 IOP measurement at 3 time-points in both eyes
- Females who are pregnant, nursing, or planning a pregnancy
- Subjects who cannot safely discontinue use of ocular hypotensive medications during the wait/washout period.
- History of ocular surgery specifically intended to lower IOP in either eye. Laser iridotomy in history is allowed
- Presence of advanced glaucoma in either eye
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description DE-126 Opthalmic Solution 0.002% QD and Vehicle QD DE-126 Ophthalmic Solution 0.002% QD DE-126 Ophthalmic Solution 0.002% is administered once daily (QD) Timolol Maleate Opthalmic Solution 0.5% BID Timolol Maleate Ophthalmic Solution 0.5% BID Timolol Maleate Ophthalmic Solution 0.5% is administered twice daily (BID)
- Primary Outcome Measures
Name Time Method Intraocular Pressure at Week 2 08:00, 10:00 and 16:00 at Week 2 Intraocular pressure (IOP), the fluid pressure inside the eye was measure by the Goldmann applanation tonometer in millimeters mercury (mmHg) at 3 time-points throughout the day. Analysis using Mixed-effects Model for Repeated Measures (MMRM).
Intraocular Pressure at Week 6 08:00, 10:00 and 16:00 at Week 6 Intraocular pressure (IOP), the fluid pressure inside the eye was measure by the Goldmann applanation tonometer in millimeters mercury (mmHg) at 3 time-points throughout the day. Analysis using Mixed-effects Model for Repeated Measures (MMRM).
Intraocular Pressure at Month 3 08:00, 10:00 and 16:00 at Month 3 Intraocular pressure (IOP), the fluid pressure inside the eye was measure by the Goldmann applanation tonometer in millimeters mercury (mmHg) at 3 time-points throughout the day. Analysis using Mixed-effects Model for Repeated Measures (MMRM).
- Secondary Outcome Measures
Name Time Method Mean Diurnal Intraocular Pressure at Month 3 Three months Mean diurnal Intraocular Pressure (IOP) was defined as the mean of the IOP valued at the three schedules timepoints (8:00, 10:00 and 16:00) at that visit for that subject.
Trial Locations
- Locations (41)
Vance Thompson Vision - ND
🇺🇸W. Fargo, North Dakota, United States
Northern New Jersey Eye Institute
🇺🇸South Orange, New Jersey, United States
Black Hills Regional Eye Institute
🇺🇸Rapid City, South Dakota, United States
Arizona Eye Center
🇺🇸Chandler, Arizona, United States
Arizona Glaucoma Specialists
🇺🇸Phoenix, Arizona, United States
Nevada Eye Care Professionals
🇺🇸Las Vegas, Nevada, United States
Walman Eye Center
🇺🇸Sun City, Arizona, United States
AdvanceMed Clinical Research-Las Vegas
🇺🇸Las Vegas, Nevada, United States
Global Research Management
🇺🇸Glendale, California, United States
Premiere Practice Management
🇺🇸Los Angeles, California, United States
North Valley Eye Medical Group
🇺🇸Mission Hills, California, United States
North Bay Eye Associates, Inc
🇺🇸Petaluma, California, United States
The Eye Research Foundation
🇺🇸Newport Beach, California, United States
University of California, Los Angeles, Doheny Eye Centers
🇺🇸Pasadena, California, United States
University of Colorado, Dept. of Opthamology
🇺🇸Aurora, Colorado, United States
Levenson Eye Associates
🇺🇸Jacksonville, Florida, United States
Sacramento Eye Consultants
🇺🇸Sacramento, California, United States
Hernando Eye Institute
🇺🇸Brooksville, Florida, United States
Mayo Clinic, Dept. of Opthamology
🇺🇸Jacksonville, Florida, United States
Bowden Eye & Associates
🇺🇸Jacksonville, Florida, United States
Dixophthal PC dba Dixon Eye Care
🇺🇸Albany, Georgia, United States
Clayton Eye Clinical Research, LLC
🇺🇸Morrow, Georgia, United States
Shettle Eye Research
🇺🇸Largo, Florida, United States
Coastal Research Associates
🇺🇸Roswell, Georgia, United States
Clinical Eye Research of Boston, LLC
🇺🇸Winchester, Massachusetts, United States
Rochester Ophthalmological Group, P.C.
🇺🇸Rochester, New York, United States
Wake Forest Health Network Ophthamology - Oak Hollow
🇺🇸High Point, North Carolina, United States
Office of Mark J. Weiss MD
🇺🇸Tulsa, Oklahoma, United States
Apex Eye Clinical Research, LLC
🇺🇸Cincinnati, Ohio, United States
Scott & Christie and Associates PC
🇺🇸Cranberry Township, Pennsylvania, United States
Wills Eye Hospital
🇺🇸Philadelphia, Pennsylvania, United States
University Eye Specialists
🇺🇸Maryville, Tennessee, United States
VRF Eye Specialty Group
🇺🇸Memphis, Tennessee, United States
Glaucoma Associates of Texas
🇺🇸Dallas, Texas, United States
R and R Eye Research LLC
🇺🇸San Antonio, Texas, United States
DCT- Shah Research LLC dba Discovery Clinical Trials
🇺🇸Mission, Texas, United States
The Cataract and Glaucoma Center
🇺🇸El Paso, Texas, United States
San Antonio Eye Center
🇺🇸San Antonio, Texas, United States
Stacy R. Smith M.D. P.C.
🇺🇸Salt Lake City, Utah, United States
Eye Associates of Fort Myers
🇺🇸Fort Myers, Florida, United States
Duke Eye Center
🇺🇸Durham, North Carolina, United States