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
NCT ID: NCT03691649
Last Updated: 2023-08-30
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
426 participants
INTERVENTIONAL
2018-09-14
2020-09-03
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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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
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
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
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
Interventions
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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
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
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Any corneal abnormality or other condition interfering with or preventing reliable tonometric measurements
12 Months
ALL
No
Sponsors
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Santen Inc.
INDUSTRY
Responsible Party
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Locations
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Arizona Glaucoma Specialists
Phoenix, Arizona, United States
DocTrials Walman Eye Center
Sun City, Arizona, United States
Havana Research Institute
Burbank, California, United States
Macy Eye Center
Los Angeles, California, United States
North Valley Eye Medical Group
Mission Hills, California, United States
North Bay Eye Associates, Inc
Petaluma, California, United States
Martel Eye Medical Group
Rancho Cordova, California, United States
Samsum Clinic (DocTrials)
Santa Barbara, California, United States
MCB Clinical Research Centers LLC
Colorado Springs, Colorado, United States
Hernando Eye Institute
Brooksville, Florida, United States
Eye Associates of Fort Myers
Fort Myers, Florida, United States
Bowden Eye & Associates
Jacksonville, Florida, United States
Shettle Eye Research
Largo, Florida, 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
Heart of America Eye Care, P.A.
Shawnee Mission, Kansas, United States
Clinical Eye Research of Boston, LLC
Winchester, Massachusetts, 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
Northern New Jersey Eye Institute
South Orange, New Jersey, 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
Apex Eye Clinical Research, LLC
Cincinnati, Ohio, United States
Ophthalmic Surgeons & Consultants of Ohio, Inc.
Columbus, Ohio, United States
Office of Mark J. Weiss MD
Tulsa, Oklahoma, United States
Scott & Christie and Associates PC
Cranberry Township, Pennsylvania, United States
Glaucoma Consultants and Center for Eye Research PA
Mt. Pleasant, South Carolina, United States
Black Hills Regional Eye Institute, LLP
Rapid City, South Dakota, United States
University Eye Specialists
Maryville, Tennessee, United States
Total Eye Care PA
Memphis, Tennessee, United States
Keystone Research Ltd. Texan Eye PA
Austin, Texas, United States
The Cataract and Glaucoma Center
El Paso, Texas, United States
Ophthalmology Associates
Fort Worth, Texas, United States
Shah Research LLC dba Discovery Clinical Trials
Mission, Texas, 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
Emerson Clinical Research Institute
Falls Church, Virginia, United States
Specialty Eye Care Centre
Bellevue, Washington, United States
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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011709IN
Identifier Type: -
Identifier Source: org_study_id
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