Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
901 participants
INTERVENTIONAL
2018-07-10
2020-02-05
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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KPI-121 0.25% Ophthalmic Suspension
KPI-121 Ophthalmic Suspension
KPI-121 Ophthalmic Suspension
Vehicle of KPI-121 0.25% Ophthalmic Suspension
Vehicle
Vehicle for KPI-121 0.25% ophthalmic suspension
Interventions
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KPI-121 Ophthalmic Suspension
KPI-121 Ophthalmic Suspension
Vehicle
Vehicle for KPI-121 0.25% ophthalmic suspension
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* History of glaucoma, IOP\>21 mmHg at the screening or randomization visits, or being treated for glaucoma in either eye.
* Diagnosis of: ongoing ocular infection; severe/serious ocular condition that in judgment of Investigator could confound study assessments or limit compliance; or have been exposed to an investigational drug within 30 days prior to screening.
* In the opinion of the Investigator or study coordinator, be unwilling or unable to comply with study protocol or unable to successfully instill eye drops.
18 Years
ALL
No
Sponsors
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Kala Pharmaceuticals, Inc.
INDUSTRY
Responsible Party
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Locations
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Investigator #133
Birmingham, Alabama, United States
Investigator #278
Dothan, Alabama, United States
Investigator #146
Chandler, Arizona, United States
Investigator #148
Phoenix, Arizona, United States
Investigator #280
Prescott, Arizona, United States
Investigator #276
Sun City, Arizona, United States
Investigator #185
Azusa, California, United States
Investigator #143
Garden Grove, California, United States
Investigator #147
Glendale, California, United States
Investigator #272
Hemet, California, United States
Investigator #155
Inglewood, California, United States
Investigator #273
Long Beach, California, United States
Investigator #130
Mission Hills, California, United States
Investigator #247
Murrieta, California, United States
Investigator #215
Newport Beach, California, United States
Site #111
Rancho Cordova, California, United States
Investigator #271
Santa Ana, California, United States
Investigator #107
Torrance, California, United States
Investigator #213
Westminster, California, United States
Investigator #218
Littleton, Colorado, United States
Investigator #184
Brooksville, Florida, United States
Investigator #262
Delray Beach, Florida, United States
Investigator #279
Fort Myers, Florida, United States
Investigator #265
Jacksonville, Florida, United States
Investigator #157
Largo, Florida, United States
Investigator #189
Tampa, Florida, United States
Investigator #136
Morrow, Georgia, United States
Investigator #268
Roswell, Georgia, United States
Investigator #266
Chicago, Illinois, United States
Investigator #187
Hoffman Estates, Illinois, United States
Investigator #151
Lake Villa, Illinois, United States
Investigator #128
Indianapolis, Indiana, United States
Investigator #250
Indianapolis, Indiana, United States
Investigator #125
New Albany, Indiana, United States
Investigator #274
Lexington, Kentucky, United States
Investigator #195
Louisville, Kentucky, United States
Investigator #168
Louisville, Kentucky, United States
Investigator #219
Winchester, Massachusetts, United States
Investigator #267
Kansas City, Missouri, United States
Investigator #123
St Louis, Missouri, United States
Investigator #106
St Louis, Missouri, United States
Investigator #126
St Louis, Missouri, United States
Investigator #131
Washington, Missouri, United States
Investigator #281
Henderson, Nevada, United States
Investigator #275
Las Vegas, Nevada, United States
Investigator #263
Las Vegas, Nevada, United States
Investigator #138
Las Vegas, Nevada, United States
Investigator #105
New York, New York, United States
Investigator #108
Rochester, New York, United States
Investigator #132
Wantagh, New York, United States
Investigator #264
Asheville, North Carolina, United States
Investigator #217
Durham, North Carolina, United States
Investigator #149
Durham, North Carolina, United States
Investigator #102
High Point, North Carolina, United States
Investigator #163
Raleigh, North Carolina, United States
Investigator #282
Southern Pines, North Carolina, United States
Investigator #269
Cincinnati, Ohio, United States
Investigator #142
Cincinnati, Ohio, United States
Investigator #137
Cleveland, Ohio, United States
Investigator #171
Mason, Ohio, United States
Investigator #224
Cranberry Township, Pennsylvania, United States
Investigator #156
Kingston, Pennsylvania, United States
Investigator #200
Lancaster, Pennsylvania, United States
Investigator #277
West Mifflin, Pennsylvania, United States
Investigator #240
Rapid City, South Dakota, United States
Investigator #127
Memphis, Tennessee, United States
Investigator #270
Austin, Texas, United States
Investigator #188
Austin, Texas, United States
Investigator #174
Cedar Park, Texas, United States
Investigator #140
El Paso, Texas, United States
Investigator #124
Houston, Texas, United States
Investigator #259
Houston, Texas, United States
Investigator #175
Lakeway, Texas, United States
Investigator #182
League City, Texas, United States
Investigator #191
League City, Texas, United States
Site #177
San Antonio, Texas, United States
Investigator #258
San Antonio, Texas, United States
Investigator #186
San Antonio, Texas, United States
Investigator #176
San Antonio, Texas, United States
Investigator #222
Layton, Utah, United States
Investigator #119
Norfolk, Virginia, United States
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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KPI-121-C-011
Identifier Type: -
Identifier Source: org_study_id
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