A Phase III Study Assessing the Efficacy and Safety of DE-117 Ophthalmic Solution Compared With Timolol Maleate Ophthalmic Solution 0.5% in Subjects With Glaucoma or Ocular Hypertension - Spectrum 3 Study
- Conditions
- Glaucoma and Ocular Hypertension
- Interventions
- Drug: DE-117 Ophthalmic Solution
- Registration Number
- NCT03691649
- Lead Sponsor
- Santen Inc.
- Brief Summary
This is a Phase III, randomized, double-masked, active-controlled, parallel-group, multi-center study. Subjects diagnosed with glaucoma or OHT who meet eligibility criteria at Visit 1 (Screening) will washout of their current topical IOP-lowering medication(s), if any. After completing the required washout period, subjects will return for Visit 2 (Baseline, Day 1). Subjects who meet all eligibility criteria at baseline will be randomized to receive double-masked treatment for 3 months. Adult subjects will receive open-label DE-117 Ophthalmic Solution for an additional 9 months.
Approximately 400 adult subjects and up to 30 pediatric subjects with glaucoma or OHT who meet all eligibility criteria will be randomized in a 1:1 ratio to receive either:
* DE-117 Ophthalmic Solution once daily and Vehicle once daily, or
* Timolol Maleate Ophthalmic Solution 0.5% twice daily. The study will evaluate the efficacy and safety of DE-117 Ophthalmic Solution compared with Timolol Maleate Ophthalmic Solution 0.5% in subjects with glaucoma or OHT through Month 3 and will provide additional safety data through Month 12 for subjects receiving DE-117.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 426
• glaucoma or ocular hypertension
- Females who are pregnant, nursing, or planning a pregnancy
- Any corneal abnormality or other condition interfering with or preventing reliable tonometric measurements
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Timolol Maleate Ophthalmic Solution 0.5% Timolol Maleate Ophthalmic Solution 0.5% Topical Timolol Maleate Ophthalmic Solution 0.5% twice daily for 3 months for all subjects, followed by DE-117 Ophthalmic Solution once daily for additional 9 month for adult subjects only DE-117 Ophthalmic Solution DE-117 Ophthalmic Solution Topical DE-117 Ophthalmic Solution once daily and Vehicle once daily for 3 months for all subjects, followed by DE-117 Ophthalmic Solution once daily for additional 9 month for adult subjects only
- Primary Outcome Measures
Name Time Method 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 measured with calibrated 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 measured with calibrated 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 1 08:00, 10:00 and 16:00 at Week 1 Intraocular Pressure (IOP), the fluid pressure inside the eye was measured with calibrated 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 (IOP) at Month 3 (First Key Secondary Endpoint) Month 3 Mean Diurnal Intraocular Pressure (IOP) at Month 3: Analysis using Mixed-Effects Model for Repeated Measures (MMRM) on observed cases.
Intraocular Pressure (IOP) at Week 1 With Baseline Mean Diurnal IOP Less Than 25 mmHg (Second Key Secondary Endpoint) 08:00, 10:00 and 16:00 at Week 1 Intraocular Pressure (IOP) at Week 1 with baseline mean diurnal IOP less than 25 mmHg (Second Key Secondary Endpoint)
Intraocular Pressure (IOP) at Month 3 With Baseline Mean Diurnal IOP Less Than 25 mmHg (Second Key Secondary Endpoint) 08:00, 10:00 and 16:00 at Month 3 Intraocular Pressure (IOP) at Month 3 with baseline mean diurnal IOP less than 25 mmHg (Second Key Secondary Endpoint)
Mean Diurnal Intraocular Pressure (IOP) at Week 1 (Third Key Secondary Endpoint) Week 1 Mean Diurnal Intraocular Pressure (IOP) at Week 1: Analysis using Mixed-Effects Model for Repeated Measures (MMRM) on observed cases.
Mean Diurnal IOP at week 1 is defined as the average IOP of all three timepoints (8AM, 10AM and 4PM) at week 1.Intraocular Pressure (IOP) at Week 6 With Baseline Mean Diurnal IOP Less Than 25 mmHg (Second Key Secondary Endpoint) 08:00, 10:00 and 16:00 at Week 6 Intraocular Pressure (IOP) at Week 6 with baseline mean diurnal IOP less than 25 mmHg (Second Key Secondary Endpoint)
Trial Locations
- Locations (47)
Heart of America Eye Care, P.A.
🇺🇸Shawnee Mission, Kansas, United States
Eye Associates of Fort Myers
🇺🇸Fort Myers, Florida, United States
Shettle Eye Research
🇺🇸Largo, Florida, United States
Northern New Jersey Eye Institute
🇺🇸South Orange, New Jersey, United States
DocTrials Walman Eye Center
🇺🇸Sun City, Arizona, United States
Hernando Eye Institute
🇺🇸Brooksville, Florida, United States
Bowden Eye & Associates
🇺🇸Jacksonville, Florida, United States
Clinical Eye Research of Boston, LLC
🇺🇸Winchester, Massachusetts, United States
Black Hills Regional Eye Institute, LLP
🇺🇸Rapid City, South Dakota, United States
University Eye Specialists
🇺🇸Maryville, Tennessee, United States
North Valley Eye Medical Group
🇺🇸Mission Hills, California, United States
Martel Eye Medical Group
🇺🇸Rancho Cordova, California, United States
North Bay Eye Associates, Inc
🇺🇸Petaluma, California, United States
MCB Clinical Research Centers LLC
🇺🇸Colorado Springs, Colorado, United States
Dixophthal PC Dba. Dixon Eye Care
🇺🇸Albany, Georgia, United States
Coastal Research Associates
🇺🇸Alpharetta, Georgia, United States
Clayton Eye Clinical Research, LLC
🇺🇸Morrow, Georgia, United States
Indiana University
🇺🇸Bloomington, Indiana, United States
NY Eye & ear Infirmary of Mt Sinai (NYEE)
🇺🇸New York, New York, United States
South Shore Eye Care, LLP
🇺🇸Wantagh, New York, United States
Asheville Eye Associates
🇺🇸Asheville, North Carolina, United States
Charlotte Eye Ear Nose & Throat Associates, PA
🇺🇸Charlotte, North Carolina, United States
Cornerstone Eye Care
🇺🇸High Point, North Carolina, United States
Scott & Christie and Associates PC
🇺🇸Cranberry Township, Pennsylvania, United States
Glaucoma Consultants and Center for Eye Research PA
🇺🇸Mount Pleasant, South Carolina, United States
Ophthalmology Associates
🇺🇸Fort Worth, Texas, United States
Total Eye Care PA
🇺🇸Memphis, Tennessee, United States
The Cataract and Glaucoma Center
🇺🇸El Paso, Texas, United States
Shah Research LLC dba Discovery Clinical Trials
🇺🇸Mission, Texas, United States
Specialty Eye Care Centre
🇺🇸Bellevue, Washington, United States
Emerson Clinical Research Institute
🇺🇸Falls Church, Virginia, United States
Office of Mark J. Weiss MD
🇺🇸Tulsa, Oklahoma, United States
Arizona Glaucoma Specialists
🇺🇸Phoenix, Arizona, United States
Havana Research Institute
🇺🇸Burbank, California, United States
Macy Eye Center
🇺🇸Los Angeles, California, United States
Samsum Clinic (DocTrials)
🇺🇸Santa Barbara, California, United States
Tauber Eye Center
🇺🇸Kansas City, Missouri, United States
Nevada Eye Care Professionals
🇺🇸Las Vegas, Nevada, United States
Wellish Vision Institute
🇺🇸Las Vegas, Nevada, United States
AdvanceMed Clinical Research-Las Vegas
🇺🇸Las Vegas, Nevada, United States
Apex Eye Clinical Research, LLC
🇺🇸Cincinnati, Ohio, United States
Ophthalmic Surgeons & Consultants of Ohio, Inc.
🇺🇸Columbus, Ohio, United States
San Antonio Eye Center
🇺🇸San Antonio, Texas, United States
R and R Eye Research LLC
🇺🇸San Antonio, Texas, United States
Delay Winter Eye Consultants LLC
🇺🇸San Antonio, Texas, United States
Stacy R. Smith M.D. P.C.
🇺🇸Salt Lake City, Utah, United States
Keystone Research Ltd. Texan Eye PA
🇺🇸Austin, Texas, United States