Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
592 participants
INTERVENTIONAL
2011-05-31
2016-12-31
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
QUADRUPLE
Study Groups
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Ophthalmic solution low dose
DE-109 44 ug
Low dose
Ophthalmic solution medium dose
DE-109 440 ug
Medium dose
Ophthalmic solution high dose
DE-109 880 ug
High dose
Interventions
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DE-109 44 ug
Low dose
DE-109 440 ug
Medium dose
DE-109 880 ug
High dose
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 18 years of age or older
* Sign informed consent
* Meet best corrected ETDRS visual acuity
Exclusion Criteria
* Suspected/confirmed central nervous system or ocular lymphoma
* Primary diagnosis of anterior uveitis
* Uncontrolled glaucoma
* Use of topical oculary medication
* Implanted device
* Significant ocular disease
* Lens/media opacities or obscured ocular media
* Intraocular surgery or treatments
* Capsulotomy
* Ocular or periocular infection
* Pupillary dilation
* History of herpetic infection
* Toxoplasmosis or toxoplasmosis scar
* Ocular malignancy
* Allergy or hypersensitivity to study drug
* Participation in other uveitis trial within 30 days
* Monoclonal antibody treatment or biologic therapy
* Any systemic condition/infection
* Immunosuppressive therapy or immunocompromised
* Malignancy remission
* Females who are pregnant or lactating and females not using adequate contraceptives
18 Years
ALL
No
Sponsors
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Santen Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Abu Abraham, MD
Role: STUDY_DIRECTOR
Santen Inc.
Locations
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Phoenix, Arizona, United States
Tucson, Arizona, United States
Beverly Hills, California, United States
Loma Linda, California, United States
Los Angeles, California, United States
Mountain View, California, United States
Sacramento, California, United States
Torrance, California, United States
Aurora, Colorado, United States
Colorado Springs, Colorado, United States
Golden, Colorado, United States
Altamonte Springs, Florida, United States
Jacksonville, Florida, United States
Miami, Florida, United States
Orlando, Florida, United States
Pensacola, Florida, United States
Tampa, Florida, United States
Winter Haven, Florida, United States
Augusta, Georgia, United States
Chicago, Illinois, United States
Oak Park, Illinois, United States
Indianapolis, Indiana, United States
Iowa City, Iowa, United States
Wichita, Kansas, United States
Baltimore, Maryland, United States
Boston, Massachusetts, United States
Cambridge, Massachusetts, United States
Peabody, Massachusetts, United States
Ann Arbor, Michigan, United States
Grand Rapids, Michigan, United States
Jackson, Michigan, United States
Royal Oak, Michigan, United States
Southfield, Michigan, United States
Edina, Minnesota, United States
St Louis, Missouri, United States
Missoula, Montana, United States
Lincoln, Nebraska, United States
Omaha, Nebraska, United States
Portsmouth, New Hampshire, United States
New Brunswick, New Jersey, United States
Newark, New Jersey, United States
Northfield, New Jersey, United States
Teaneck, New Jersey, United States
Toms River, New Jersey, United States
Albany, New York, United States
New York, New York, United States
Orchard Park, New York, United States
Rochester, New York, United States
Slingerlands, New York, United States
Southern Pines, North Carolina, United States
Winston-Salem, North Carolina, United States
Cleveland, Ohio, United States
Eugene, Oregon, United States
Camp Hill, Pennsylvania, United States
Philadelphia, Pennsylvania, United States
Pittsburgh, Pennsylvania, United States
Reading, Pennsylvania, United States
West Mifflin, Pennsylvania, United States
Columbia, South Carolina, United States
Ladson, South Carolina, United States
Rapid City, South Dakota, United States
Knoxville, Tennessee, United States
Arlington, Texas, United States
Austin, Texas, United States
Dallas, Texas, United States
Fort Worth, Texas, United States
Houston, Texas, United States
McAllen, Texas, United States
San Antonio, Texas, United States
Salt Lake City, Utah, United States
Burlington, Vermont, United States
Richmond, Virginia, United States
Virginia Beach, Virginia, United States
Milwaukee, Wisconsin, United States
Buenos Aires, , Argentina
Mendoza, , Argentina
Olivos, , Argentina
Pilar, , Argentina
Rosario, , Argentina
San Juan Bautista, , Argentina
Graz, , Austria
Klagenfurt, , Austria
Americana, , Brazil
Araraquara, , Brazil
Londrina, , Brazil
Recife, , Brazil
Rio de Janeiro, , Brazil
São Paulo, , Brazil
Sorocaba, , Brazil
Santiago, , Chile
Bogotá, , Colombia
Cali, , Colombia
Floridablanca, , Colombia
Medellín, , Colombia
Marseille, , France
Nantes, , France
Paris, , France
Berlin, , Germany
Cologne, , Germany
Freiburg im Breisgau, , Germany
Heidelberg, , Germany
München, , Germany
Münster, , Germany
Tübingen, , Germany
Ahmedabad, , India
Bangalore, , India
Bhubaneshwar, , India
Chennai, , India
Hyderabad, , India
Kolkata, , India
Madurai, , India
Mumbai, , India
New Delhi, , India
Noida, , India
Afula, , Israel
Beersheba, , Israel
Haifa, , Israel
Jerusalem, , Israel
Petah Tikva, , Israel
Ramat Gan, , Israel
Rehovot, , Israel
Tel Aviv, , Israel
Bologna, , Italy
Florence, , Italy
Milan, , Italy
Padua, , Italy
Pisa, , Italy
Reggio Emilia, , Italy
Hokkaido, , Japan
Osaka, , Japan
Sapporo, , Japan
Sendai, , Japan
Tokyo, , Japan
Lima, , Peru
Trujillo, , Peru
Lodz, , Poland
Lublin, , Poland
Poznan, , Poland
Wroclaw, , Poland
Alicante, , Spain
Barcelona, , Spain
Madrid, , Spain
Santiago de Compostela, , Spain
Torrevieja, , Spain
Ankara, , Turkey (Türkiye)
Istanbul, , Turkey (Türkiye)
Izmir, , Turkey (Türkiye)
Belfast, , United Kingdom
Bradford, , United Kingdom
Bristol, , United Kingdom
London, , United Kingdom
Countries
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Other Identifiers
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32-007
Identifier Type: -
Identifier Source: org_study_id
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