A Study Assessing the Safety and Efficacy of DE-117 Ophthalmic Solution in Patients With POAG or OHT
NCT ID: NCT01654484
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
PHASE1/PHASE2
60 participants
INTERVENTIONAL
2012-07-31
2012-11-30
Brief Summary
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Detailed Description
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Stage One will explore the dose response of three concentrations of DE-117 as monotherapy compared with 0.0015% tafluprost and placebo. The safety and efficacy of DE-117 as adjunctive therapy (with 0.0015% tafluprost) compared with 0.0015% tafluprost and placebo will also be evaluated. In addition, the additive effect of adjunctive therapy of each concentration will be compared with the corresponding monotherapy concentration.
Stage Two will assess the safety and efficacy of the optimal DE-117 concentration as monotherapy compared with 0.0015% tafluprost. The safety and efficacy of the optimal DE-117 concentration as adjunctive therapy (with 0.0015% tafluprost) compared with DE-117 monotherapy and 0.0015% tafluprost will also be evaluated.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Low Dose DE-117
Monotherapy
DE-117
Ophthalmic Solution, QD, 28 Days
Medium Dose DE-117
Monotherapy
DE-117
Ophthalmic Solution, QD, 28 Days
High Dose DE-117
Monotherapy
DE-117
Ophthalmic Solution, QD, 28 Days
Low Dose DE-117 and 0.0015% tafluprost
Adjunctive Therapy
DE-117 and 0.0015% tafluprost
Ophthalmic Solutions, QD, 28 days
Med. Dose DE-117 and 0.0015% tafluprost
Adjunctive Therapy
DE-117 and 0.0015% tafluprost
Ophthalmic Solutions, QD, 28 days
High Dose DE-117 and 0.0015% tafluprost
Adjunctive Therapy
DE-117 and 0.0015% tafluprost
Ophthalmic Solutions, QD, 28 days
0.0015% tafluprost
Monotherapy
0.0015% tafluprost
Ophthalmic Solution, QD, 28 days
Placebo
Monotherapy
Placebo
Ophthalmic Solution, QD, 28 days
Interventions
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DE-117
Ophthalmic Solution, QD, 28 Days
0.0015% tafluprost
Ophthalmic Solution, QD, 28 days
DE-117 and 0.0015% tafluprost
Ophthalmic Solutions, QD, 28 days
Placebo
Ophthalmic Solution, QD, 28 days
Eligibility Criteria
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Inclusion Criteria
2. Current diagnosis of primary open-angle glaucoma or ocular hypertension in both eyes
3. Qualifying intraocular pressure (IOP) in at least one eye at Baseline
Exclusion Criteria
2. Anticipate the need to initiate or modify medication (systemic or topical) that is known to affect intraocular pressure (IOP) during the study period
3. Females who are pregnant, nursing or planning a pregnancy
4. Presence of any abnormality or significant illness that could be expected to interfere with the study.
18 Years
ALL
No
Sponsors
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Santen Inc.
INDUSTRY
Responsible Party
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Locations
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Santen Investigational Site
Newport Beach, California, United States
Santen Investigational Site
Deerfield Beach, Florida, United States
Santen Investigational Site
Largo, Florida, United States
Santen Investigational Site
Morrow, Georgia, United States
Santen Investigational Site
Roswell, Georgia, United States
Santen Investigational Site
Rochester, New York, United States
Santen Investigational Site
Cleveland, Ohio, United States
Santen Investigational Site
Austin, Texas, United States
Santen Investigational Site
Fort Worth, Texas, United States
Santen Investigational Site
San Antonio, Texas, United States
Countries
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Other Identifiers
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33-001
Identifier Type: -
Identifier Source: org_study_id
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