Study Assessing the Safety and Efficacy of DE-117 Ophthalmic Solution Once Daily and Twice Daily in Subjects With Primary Open-Angle Glaucoma SPECTRUM 6
NCT ID: NCT03858894
Last Updated: 2020-08-04
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
98 participants
INTERVENTIONAL
2019-01-28
2019-06-20
Brief Summary
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Approximately 100 subjects with POAG or OHT will be randomized in a 1:1 ratio to either:
* DE-117 ophthalmic solution 0.002% QD (Once Daily)
* DE-117 ophthalmic solution 0.002% BID (Twice Daily)
This study will consist of a screening period of up to 35 days including a washout period of up to 28 days (+ 7 days window), and a 6-week double-masked treatment period.
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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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Drug Arm: DE-117 QD
DE-117 Ophthalmic Solution QD (20:00) and Vehicle (8:00; no active DE-117 ingredient) QD
DE-117 Ophthalmic Solution QD
DE-117 ophthalmic solution QD and Vehicle (no active DE-117 ingredient) QD add one drop in each eye
Test Arm: DE-117 BID
DE-117 Ophthalmic Solution BID Twice daily (20:00 and 8:00)
DE-117 Ophthalmic Solution BID
DE-117 ophthalmic solution BID twice Daily (20:00 and 8:00) add one drop in each eye
Interventions
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DE-117 Ophthalmic Solution QD
DE-117 ophthalmic solution QD and Vehicle (no active DE-117 ingredient) QD add one drop in each eye
DE-117 Ophthalmic Solution BID
DE-117 ophthalmic solution BID twice Daily (20:00 and 8:00) add one drop in each eye
Eligibility Criteria
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Inclusion Criteria
* Have a diagnosis of POAG or OHT in both eyes, or one eye with POAG and the other with OHT.
* 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
Exclusion Criteria
* 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 180 days prior to Screening and throughout the study in either eye
* Females who are pregnant, nursing, or planning a pregnancy
18 Years
ALL
No
Sponsors
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Santen Inc.
INDUSTRY
Responsible Party
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Locations
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East West Eye Institute
Los Angeles, California, United States
Danbury Eye Specialist
Danbury, Connecticut, United States
Hernando Eye Institute
Brooksville, Florida, United States
Levenson Eye Associates
Jacksonville, Florida, United States
Seidenberg Protzko Eye Associates
Havre de Grace, Maryland, United States
Tekwani Vision Center
St Louis, Missouri, United States
Eye Associates/SurgiCenter of Vineland
Vineland, New Jersey, United States
Ophthalmic Consultants of Long Island
Lynbrook, New York, United States
Apex Eye Clinical Research, LLC
Cincinnati, Ohio, United States
Abrams Eye Center
Cleveland, Ohio, United States
Scott & Christie and Associates PC
Cranberry Township, Pennsylvania, United States
University Eye Specialist
Maryville, Tennessee, United States
Advanced Vision Research
Nashville, Tennessee, 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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011712IN
Identifier Type: -
Identifier Source: org_study_id
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