Study Assessing Safety and Efficacy of DE-101 Ophthalmic Suspension in Dry Eye Patients
NCT ID: NCT01118754
Last Updated: 2011-11-03
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
132 participants
INTERVENTIONAL
2010-04-30
2010-12-31
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
TRIPLE
Study Groups
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DE-101 ophthalmic suspension high dose
DE-101 ophthalmic suspension
Ophthalmic suspention; QID
DE-101 ophthalmic suspension low dose
DE-101 ophthalmic suspension
Ophthalmic suspention; QID
DE-101 ophthalmic suspension
Ophthalmic suspension; QID
DE-101 ophthalmic suspension vehicle
DE-101 ophthalmic suspension
Ophthalmic suspention; QID
DE-101 ophthalmic suspension vehicle
ophthalmic suspension vehicle; QID
Interventions
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DE-101 ophthalmic suspension
Ophthalmic suspention; QID
DE-101 ophthalmic suspension
Ophthalmic suspension; QID
DE-101 ophthalmic suspension vehicle
ophthalmic suspension vehicle; QID
Eligibility Criteria
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Inclusion Criteria
* 18 years or older, and sign written informed consent
* negative pregnancy test and utilizing reliable contraceptive throughout study
Exclusion Criteria
* any ocular surgery within 90 days of study
* laser refractive surgery within one year of study
* ocular, lid disease/abnormalities that may interfere with the study
* corneal transplants
* uncontrolled systemic conditions
* females who are pregnant or nursing or planning a pregnancy, or females of childbearing potential who are not using a reliable method of contraception
* participated in another drug trial within 30 days prior to study
18 Years
ALL
No
Sponsors
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Santen Inc.
INDUSTRY
Responsible Party
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Locations
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Inglewood, California, United States
Torrance, California, United States
Bloomfield, Connecticut, United States
Indianapolis, Indiana, United States
New Albany, Indiana, United States
Gretna, Louisiana, United States
Bangor, Maine, United States
Cleveland, Ohio, United States
Philadelphia, Pennsylvania, United States
San Antonio, Texas, United States
Countries
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Other Identifiers
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26-004
Identifier Type: -
Identifier Source: org_study_id