Safety and Efficacy of KPI-121 Compared to Placebo in Subjects With Dry Eye Disease



Status:Completed
Conditions:Ocular, Ocular
Therapuetic Areas:Ophthalmology
Healthy:No
Age Range:18 - Any
Updated:7/19/2018
Start Date:June 2016
End Date:September 2017

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A Phase 3, Double-Masked, Randomized, Controlled Study of KPI-121 0.25% Ophthalmic Suspension Compared to Vehicle in Subjects With Dry Eye Disease

The primary purpose of this study is to determine the efficacy and safety of KPI-121 0.25%
ophthalmic suspension compared to vehicle (placebo) in subjects who have a documented
clinical diagnosis of dry eye disease. The product will be studied over 14 days, with 1-2
drops instilled in each eye four times daily (QID).

This is a Phase 3, multi-center, double-masked, randomized, vehicle-controlled,
parallel-group study designed to evaluate the safety and efficacy of KPI-121 0.25% ophthalmic
suspension versus vehicle in subjects with dry eye disease.

Inclusion Criteria:

- Have a documented clinical diagnosis of dry eye disease in both eyes

Exclusion Criteria:

- Known hypersensitivity or contraindication to the investigational product(s) or
components

- 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.
We found this trial at
62
sites
Westerville, Ohio 43082
Principal Investigator: Kenneth Beckman, MD
Phone: 614-890-5692
2006
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from 98109
Westerville, OH
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Artesia, California 90701
Principal Investigator: Kenneth Sall, MD
Phone: 562-804-1974
976
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from 98109
Artesia, CA
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Austin, Texas 78731
Principal Investigator: Yen Nieman, MD
Phone: 512-451-4400
1765
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from 98109
Austin, TX
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Azusa, California 91702
Principal Investigator: Milton M Hom, OD
Phone: 626-963-7100
960
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from 98109
Azusa, CA
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Birmingham, Alabama 35294
Principal Investigator: Kelly Nichols, OD, PhD
Phone: 205-934-6763
2079
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from 98109
Birmingham, AL
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Bloomington, Minnesota 55431
Principal Investigator: David Hardten, MD
Phone: 952-567-6111
1392
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from 98109
Bloomington, MN
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Boston, Massachusetts 02114
Principal Investigator: Jason Rothman, MD
Phone: 617-314-2703
2485
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from 98109
Boston, MA
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Brooksville, Florida 34613
Principal Investigator: Leonard Cacioppo, MD
Phone: 352-596-4030
2501
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Brooksville, FL
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Campbell, California 95008
Principal Investigator: Larry Wan, OD
Phone: 408-866-2020
715
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Campbell, CA
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Chandler, Arizona
Principal Investigator: Michael Depenbusch, MD
Phone: 480-999-5458
1131
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Chandler, AZ
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Chattanooga, Tennessee 37411
Principal Investigator: Charles Kirby, MD
Phone: 423-892-3937
2083
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Chattanooga, TN
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Cranberry Township, Pennsylvania 16066
Principal Investigator: Daniel Zimmer, MD
Phone: 724-772-5420
2119
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Cranberry Township, PA
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Draper, Utah 84020
Principal Investigator: Majid Moshirfar, MD
Phone: 801-568-0200
715
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Draper, UT
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Edgewood, Kentucky 41017
Principal Investigator: Brad Genereux, OD
Phone: 859-331-9000
1968
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Edgewood, KY
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El Paso, Texas 79902
Principal Investigator: Louis Alpern, MD
Phone: 915-545-2333
1377
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El Paso, TX
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Eugene, Oregon 97401
Principal Investigator: Annette Sims, MD
Phone: 541-687-2110
249
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Eugene, OR
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Garden Grove, California 92843
Principal Investigator: James Boyce, MD
Phone: 714-534-8373
984
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Garden Grove, CA
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Glendale, California 91205
Principal Investigator: Sherif M El-Harazi, MD
Phone: 818-246-2560
956
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Glendale, CA
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High Point, North Carolina 27262
Principal Investigator: Robert DaVanzo, MD
Phone: 336-802-2255
2290
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High Point, NC
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Hoffman Estates, Illinois
Principal Investigator: Parag Majmudar, MD
Phone: 847-748-3553
1704
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Hoffman Estates, IL
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Houston, Texas 77025
Principal Investigator: Richard J Ou
Phone: 832-553-7140
1891
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Houston, TX
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Houston, Texas 77055
Principal Investigator: Jeffrey Whitsett, MD
Phone: 713-365-9099
1884
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Houston, TX
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Houston, Texas 77034
Principal Investigator: Nancy Stephens, OD
Phone: 281-338-0425
1905
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Houston, TX
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Houston, Texas 77204
Principal Investigator: Daniel Powell, OD, PhD
Phone: 713-743-2736
1893
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Houston, TX
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Indianapolis, Indiana 46260
Principal Investigator: Kathleen Kelley, OD
Phone: 317-814-2996
1862
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Indianapolis, IN
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Irvine, California 92697
Principal Investigator: Marjan Farid, MD
Phone: 714-456-7741
994
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Irvine, CA
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Jonesboro, Arkansas 72401
Principal Investigator: Thomas Nix
Phone: 870-934-5210
1806
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Kansas City, Missouri 64111
Principal Investigator: Joseph Tauber, MD
Phone: 816-531-9100
1504
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Kingston, Pennsylvania 18704
Principal Investigator: Harvey J Reiser, MD
Phone: 570-714-5910
2296
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Lake Jackson, Texas 77566
Principal Investigator: Jonathan P. Grady, MD
Phone: 979-297-2961
1922
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Lakeland, Florida 33805
Principal Investigator: Jay Mulaney, MD
Phone: 863-686-1010
2543
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Lakeland, FL
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Largo, Florida
Principal Investigator: Philip L Shettle, DO
Phone: 727-674-2500
2514
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Largo, FL
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Las Vegas, Nevada 89148
Principal Investigator: Jack Abrams, MD
Phone: 702-515-9648
878
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Las Vegas, NV
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Lexington, Kentucky 40509
Principal Investigator: Bruce Koffler, MD
Phone: 859-263-4631
2005
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Lexington, KY
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Los Angeles, California
Principal Investigator: Jonathan Macy, MD
Phone: 310-657-2777
962
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Los Angeles, CA
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Los Angeles, California 90067
Principal Investigator: Nicole Fram, MD
Phone: 310-229-1220
962
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Louisville, Kentucky 40217
Principal Investigator: Gregory Sulkowski, MD
Phone: 502-458-9004
1941
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Louisville, KY
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Louisville, Kentucky 40206
Principal Investigator: John Meyer, MD
Phone: 502-589-1500
1941
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Memphis, Tennessee
Principal Investigator: David Evans, OD
Phone: 901-761-4620
1864
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Memphis, TN
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Mission Hills, California
Principal Investigator: Steven Rauchman, MD
Phone: 818-365-0606
944
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Morgantown, West Virginia 26505
Principal Investigator: Heath Lemley, MD
Phone: 304-598-3301
2161
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Morrow, Georgia 30260
Principal Investigator: Harvey DuBiner, MD
Phone: 770-968-8888
2188
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Morrow, GA
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Nashville, Tennessee 37203
Principal Investigator: Melissa Toyos, MD
Phone: 615-327-4015
1971
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New Albany, Indiana 47150
Principal Investigator: Steve Wilson, OD
Phone: 812-948-0616
1935
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New Albany, IN
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New York, New York 10013
Principal Investigator: Raymond Fong, MD
Phone: 212-274-1900
2401
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Newport Beach, California
Principal Investigator: David Wirta, MD
Phone: 949-650-1863
995
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Newport Beach, CA
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Norfolk, Virginia 23502
Principal Investigator: John Sheppard, MD
Phone: 757-961-2948
2434
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Ormond Beach, Florida 32174
Principal Investigator: Mark Rubin, MD
2527
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Ormond Beach, FL
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Poway, California 92064
Principal Investigator: Jeffrey Lozier, MD
Phone: 858-613-2965
1050
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Poway, CA
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Rancho Cordova, California 95670
Principal Investigator: Joseph R Martel, MD
Phone: 916-631-7860
628
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Rancho Cordova, CA
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Redding, California
Principal Investigator: Bruce E Silverstein, MD
Phone: 530-223-2500
486
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Redding, CA
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Rockville Centre, New York 11570
Principal Investigator: Henry Perry, MD
Phone: 516-705-7140
2420
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Rockville Centre, NY
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9911 Kennerly Road
Saint Louis, Missouri 63128
1717
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Saint Louis, MO
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San Antonio, Texas 78230
Principal Investigator: John Kozlovsky, MD
Phone: 210-541-0123
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San Diego, California
Principal Investigator: Barry Katzman, MD
Phone: 619-697-4600
1065
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Spokane, Washington 99204
Principal Investigator: Randall Jacobson, MD
Phone: 509-623-9768
229
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Tampa, Florida 33603
Principal Investigator: Bernard Perez, MD
Phone: 813-875-6588
2525
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Torrance, California 90505
Principal Investigator: Damien Goldberg, MD
Phone: 310-602-5640
977
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Torrance, CA
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Washington, Missouri 63090
Principal Investigator: Michael Korenfeld, MD
Phone: 636-390-3999
1686
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Washington, MO
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Westminster, California 92683
Principal Investigator: Michael Tran, MD
Phone: 714-839-2077
985
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Westminster, CA
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Wilkes-Barre, Pennsylvania 18702
Principal Investigator: Frank Bucci, MD
Phone: 570-270-5281
2298
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Wilkes-Barre, PA
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Winston-Salem, North Carolina 27101
Principal Investigator: James D Branch, MD
Phone: 336-723-0748
2276
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Winston-Salem, NC
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