Safety and Efficacy Study of DE-110 Ophthalmic Suspension for the Treatment of Dry Eye Disease
NCT ID: NCT01239069
Last Updated: 2014-05-21
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
140 participants
INTERVENTIONAL
2010-11-30
2011-10-31
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
SINGLE
Study Groups
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DE-110 ophthalmic suspension high dose
DE-110 ophthalmic suspension high dose
ophthalmic suspension; high dose; QID
DE-110 ophthalmic suspension low dose
DE-110 ophthalmic suspension low dose
ophthalmic suspension; low dose; QID
Placebo
Placebo
DE-110 ophthalmic suspension vehicle;QID
Interventions
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DE-110 ophthalmic suspension high dose
ophthalmic suspension; high dose; QID
DE-110 ophthalmic suspension low dose
ophthalmic suspension; low dose; QID
Placebo
DE-110 ophthalmic suspension vehicle;QID
Eligibility Criteria
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Inclusion Criteria
* Not wear contact lenses during study
* 18 years or older
* Understand and provide written consent
* Negative pregnancy test and use acceptable method of contraception
Exclusion Criteria
* Any type of ocular surgery
* Diagnosis of on-going ocular infection and/or allergic conjunctivitis
* Uncontrolled systemic conditions/lid abnormalities
* Corneal transplants
* Females who are pregnant, nursing or planning a pregnancy
* Participation in another drug trial concurrently or 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
Newport Beach, California, United States
Petaluma, California, United States
Torrance, California, United States
Bloomfield, Connecticut, United States
Bradenton, Florida, United States
Brooksville, Florida, United States
Largo, Florida, United States
Rosewell, Georgia, United States
Louisville, Kentucky, United States
Bangor, Maine, United States
Cleveland, Ohio, United States
San Antonio, Texas, United States
Norfolk, Virginia, United States
Countries
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Other Identifiers
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30-002
Identifier Type: -
Identifier Source: org_study_id
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