Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
107 participants
INTERVENTIONAL
2018-09-27
2022-01-13
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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DE-117 Ophthalmic Solution 0.002%
Interventional treatment will be made with DE-117 Ophthalmic Solution 0.002% once daily in the evening for the duration of the 3 month treatment period.
DE-117 Ophthalmic Solution
Interventional treatment will be made with DE-117 Ophthalmic Solution 0.002% once daily in the evening for the duration of the 3 month treatment period.
Interventions
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DE-117 Ophthalmic Solution
Interventional treatment will be made with DE-117 Ophthalmic Solution 0.002% once daily in the evening for the duration of the 3 month treatment period.
Eligibility Criteria
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Inclusion Criteria
* Provide signed written informed consent.
* Diagnosis of POAG or OHT in both eyes.
* 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 after latanoprost Run-in Period.
* Qualifying Anterior chamber angle.
* Qualifying IOP measurement at 3 time-points during latanoprost Run-in Period.
Exclusion Criteria
* Patients with prior exposure to DE-117.
* History of ocular surgery specifically intended to lower IOP
* 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 Visit 1 (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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Arizona Eye Center
Chandler, Arizona, United States
Global Research Management
Glendale, California, United States
North Valley Eye Medical Group
Mission Hills, California, United States
Eye Research Foundation
Newport Beach, California, United States
North Bay Eye Associates
Petaluma, California, United States
Martel Eye Medical Group
Rancho Cordova, California, United States
Danbury Eye Physicians & Surgeons
Danbury, Connecticut, United States
Shettle Eye Research, Inc.
Largo, Florida, United States
International Eye Associates, PA
Ormond Beach, Florida, United States
Dixon Eye Care
Albany, Georgia, United States
Clayton Eye Clinical Research, LLC
Morrow, Georgia, United States
Coastal Research Associates, LEC
Roswell, Georgia, United States
Heart of America Eye Care, P.A.
Shawnee Mission, Kansas, United States
Tekwani Vision Center
St Louis, Missouri, United States
Comprehensive Eye Care Ltd
Washington, Missouri, United States
NYU Langone Health Department of Ophthalmology
New York, New York, United States
Rochester Ophthalmological Group, PC
Rochester, New York, United States
South Shore Eye Center
Wantagh, New York, United States
Asheville Eye Associates, PLLC
Asheville, North Carolina, United States
Mundorf Eye Center
Charlotte, North Carolina, United States
Cornerstone Health Care
High Point, North Carolina, United States
Apex Eye Clinical Research, LLC
Cincinnati, Ohio, United States
Abrams Eye Center
Cleveland, Ohio, United States
The Eye Institute
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
Total Eye Care PA
Memphis, Tennessee, United States
VRF Eye Specialty Group
Memphis, Tennessee, United States
Nashville Vision Associates
Nashville, Tennessee, United States
Texas Eye, PA
Austin, Texas, United States
Eye Clinic of Texas
League City, Texas, United States
Medical Center Ophthalmology Associates
San Antonio, Texas, United States
Countries
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References
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Panarelli JF, Bowden EC, Tepedino ME, Odani-Kawabata N, Pei Z, McLaurin EB, Ropo A. Omidenepag Isopropyl in Latanoprost Low/Nonresponders With Primary Open Angle Glaucoma or Ocular Hypertension: A Phase 3, Nonrandomized, Two-Phase, Open-Label Study. J Glaucoma. 2023 Dec 1;32(12):999-1005. doi: 10.1097/IJG.0000000000002321. Epub 2023 Oct 17.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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011711IN
Identifier Type: -
Identifier Source: org_study_id
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