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 4 Study
NCT ID: NCT03691662
Last Updated: 2023-08-09
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
417 participants
INTERVENTIONAL
2018-09-27
2019-10-23
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.
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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
DE-117 Ophthalmic Solution
Topical DE-117 Ophthalmic Solution once daily and Vehicle once daily for 3 months
Timolol Maleate Ophthalmic Solution 0.5%
Topical Timolol Maleate Ophthalmic Solution 0.5% twice daily for 3 months
Timolol Maleate Ophthalmic Solution 0.5%
Topical Timolol Maleate Ophthalmic Solution 0.5% twice daily for 3 months
Interventions
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DE-117 Ophthalmic Solution
Topical DE-117 Ophthalmic Solution once daily and Vehicle once daily for 3 months
Timolol Maleate Ophthalmic Solution 0.5%
Topical Timolol Maleate Ophthalmic Solution 0.5% twice daily for 3 months
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 Eye Center
Chandler, Arizona, United States
M & M Eye Institute
Prescott, Arizona, United States
Global Research Management
Glendale, California, United States
United Medical Research Inst
Inglewood, California, United States
Eye Research Foundation
Newport Beach, California, United States
North Bay Eye Associates Inc.
Petaluma, California, United States
Sacramento Eye Consultants
Sacramento, California, United States
AdvanceMed Clinical Research
San Diego, California, United States
Michael K. Tran, MD, Inc.
Westminster, California, United States
Haas Vision Center
Colorado Springs, Colorado, United States
Florida Ophthalmic Institute
Gainesville, Florida, United States
St. Michaels Eye Laser Institute
Largo, Florida, United States
International Eye Associates PA
Ormond Beach, Florida, United States
East Florida Eye Institute
Stuart, Florida, United States
Clayton Eye Clinical Research, LLC
Morrow, Georgia, United States
Seidenberg Protzko Eye Associates
Havre de Grace, Maryland, United States
Great Lakes Eye Care P.C
Saint Joseph, Michigan, United States
Discover Vision Centers
Independence, Missouri, United States
Silverstein Eye Centers
Kansas City, Missouri, United States
Comprehensive Eye Care Ltd.
Washington, Missouri, United States
AdvanceMed Clinical Research
Las Vegas, Nevada, United States
Rochester Ophthalmological Group, PC
Rochester, New York, United States
Asheville Eye Associates
Asheville, North Carolina, United States
Abrams Eye Center
Cleveland, Ohio, United States
Total Eye Care PA
Memphis, Tennessee, United States
VRF Eye Specialty Group
Memphis, Tennessee, United States
Glaucoma Associates of Texas
Dallas, Texas, United States
Houston Eye Associates HEA - Gramercy Location
Houston, Texas, United States
Baylor College of Medicine Alkek Eye Center
Houston, Texas, United States
The Eye Clinic of Texas
League City, Texas, United States
Medical Center Ophthalmology Associates
San Antonio, Texas, United States
Stacy R. Smith M.D. P.C.
Salt Lake City, Utah, United States
Vistar Eye Center
Roanoke, Virginia, United States
Tidewater Clinical Research
Virginia Beach, Virginia, 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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011710IN
Identifier Type: -
Identifier Source: org_study_id
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