Multi-center Phase II Study Assessing the Safety and Efficacy of DE-117 Ophthalmic Solution in Subjects With Primary Open-angle Glaucoma or Ocular Hypertension
NCT ID: NCT02179008
Last Updated: 2018-04-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
184 participants
INTERVENTIONAL
2014-06-30
2015-01-31
Brief Summary
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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 Low Dose ophthalmic solution
One drop Low Dose DE-117 in each eye QD for 90 days
DE-117 Low Dose ophthalmic solution
Low Dose DE-117 ophthalmic solution
DE-117 Low/Middle Dose ophthalmic solution
One drop DE-117 Low/Middle Dose ophthalmic solution in each eye QD for 90 days
DE-117 Low/Middle Dose ophthalmic solution
Low/Middle Dose DE-117
DE-117 Middle Dose ophthalmic solution
One drop Middle Dose DE-117 in each eye QD for 90 days
DE-117 Middle Dose ophthalmic solution
Middle Dose DE-117
DE-117 Middle/High Dose ophthalmic solution
One drop Middle/High Dose DE-117 in each eye QD for 90 days
DE-117 Middle/High Dose ophthalmic solution
Middle/High Dose DE-117
DE-117 High Dose ophthalmic solution
One drop High Dose DE-117 in each eye QD for 90 days
DE-117 High Dose ophthalmic solution
High Dose DE-117
latanoprost ophthalmic solution 0.005%
One drop latanaprost in each eye QD for 90 days
latanoprost ophthalmic solution 0.005%
0.005% latanoprost
Interventions
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DE-117 Low Dose ophthalmic solution
Low Dose DE-117 ophthalmic solution
DE-117 Low/Middle Dose ophthalmic solution
Low/Middle Dose DE-117
DE-117 Middle Dose ophthalmic solution
Middle Dose DE-117
DE-117 Middle/High Dose ophthalmic solution
Middle/High Dose DE-117
DE-117 High Dose ophthalmic solution
High Dose DE-117
latanoprost ophthalmic solution 0.005%
0.005% latanoprost
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Qualifying intraocular pressure in at least one eye at Baseline
* Qualifying corrected ETDRS visual acuity in each eye
* Qualifying central cornea thickness in each eye
Exclusion Criteria
* Diagnosis of primary open-angle glaucoma or ocular hypertension due to etiology known to be non-responsive to conventional drug therapy
* Evidence of advanced glaucoma, visual field defect or progressive visual field loss that that do not meet the study criteria
* History of ocular surgery specifically intended to lower IOP
* History of any ocular or systemic abnormality or condition that may put the subject at significant risk, may confound study results, or may interfere significantly with the subject's participation in the study
* Intended or current use of any ocular medications other than study medications during the study
* Use of contact lenses within one week prior to Baseline (Day 1) until end of treatment
* Known allergy or sensitivity to any components of the study medications
* Use of steroids (systemic) within 30 days prior to Visit 1 (Screening)
* Anticipate the need to initiate or modify an existing chronic therapy that could substantially affect IOP or the study outcomes during the study period
* 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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Chandler, Arizona, United States
Artesia, California, United States
Glendale, California, United States
Long Beach, California, United States
Newport Beach, California, United States
Largo, Florida, United States
Morrow, Georgia, United States
Roswell, Georgia, United States
Rochester, New York, United States
High Point, North Carolina, United States
Cleveland, Ohio, United States
Austin, Texas, United States
Houston, Texas, United States
San Antonio, Texas, United States
Countries
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Other Identifiers
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33-003
Identifier Type: -
Identifier Source: org_study_id
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