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
Rancho Cordova, California 95670
Principal Investigator: Joseph R Martel, MD
Phone: 916-631-7860
1273
mi
from
Rancho Cordova, CA
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Artesia, California 90701
Principal Investigator: Kenneth Sall, MD
Phone: 562-804-1974
1163
mi
from
Artesia, CA
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Austin, Texas 78731
Principal Investigator: Yen Nieman, MD
Phone: 512-451-4400
511
mi
from
Austin, TX
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Azusa, California 91702
Principal Investigator: Milton M Hom, OD
Phone: 626-963-7100
1148
mi
from
Azusa, CA
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Birmingham, Alabama 35294
Principal Investigator: Kelly Nichols, OD, PhD
Phone: 205-934-6763
683
mi
from
Birmingham, AL
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Bloomington, Minnesota 55431
Principal Investigator: David Hardten, MD
Phone: 952-567-6111
542
mi
from
Bloomington, MN
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Boston, Massachusetts 02114
Principal Investigator: Jason Rothman, MD
Phone: 617-314-2703
1444
mi
from
Boston, MA
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Brooksville, Florida 34613
Principal Investigator: Leonard Cacioppo, MD
Phone: 352-596-4030
1093
mi
from
Brooksville, FL
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Campbell, California 95008
Principal Investigator: Larry Wan, OD
Phone: 408-866-2020
1319
mi
from
Campbell, CA
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Chandler, Arizona
Principal Investigator: Michael Depenbusch, MD
Phone: 480-999-5458
844
mi
from
Chandler, AZ
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Chattanooga, Tennessee 37411
Principal Investigator: Charles Kirby, MD
Phone: 423-892-3937
721
mi
from
Chattanooga, TN
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Cranberry Township, Pennsylvania 16066
Principal Investigator: Daniel Zimmer, MD
Phone: 724-772-5420
967
mi
from
Cranberry Township, PA
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Draper, Utah 84020
Principal Investigator: Majid Moshirfar, MD
Phone: 801-568-0200
775
mi
from
Draper, UT
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Edgewood, Kentucky 41017
Principal Investigator: Brad Genereux, OD
Phone: 859-331-9000
722
mi
from
Edgewood, KY
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El Paso, Texas 79902
Principal Investigator: Louis Alpern, MD
Phone: 915-545-2333
642
mi
from
El Paso, TX
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Eugene, Oregon 97401
Principal Investigator: Annette Sims, MD
Phone: 541-687-2110
1382
mi
from
Eugene, OR
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Garden Grove, California 92843
Principal Investigator: James Boyce, MD
Phone: 714-534-8373
1158
mi
from
Garden Grove, CA
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Glendale, California 91205
Principal Investigator: Sherif M El-Harazi, MD
Phone: 818-246-2560
1166
mi
from
Glendale, CA
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High Point, North Carolina 27262
Principal Investigator: Robert DaVanzo, MD
Phone: 336-802-2255
990
mi
from
High Point, NC
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Hoffman Estates, Illinois
Principal Investigator: Parag Majmudar, MD
Phone: 847-748-3553
593
mi
from
Hoffman Estates, IL
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Houston, Texas 77025
Principal Investigator: Richard J Ou
Phone: 832-553-7140
573
mi
from
Houston, TX
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Houston, Texas 77055
Principal Investigator: Jeffrey Whitsett, MD
Phone: 713-365-9099
565
mi
from
Houston, TX
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Houston, Texas 77034
Principal Investigator: Nancy Stephens, OD
Phone: 281-338-0425
582
mi
from
Houston, TX
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Houston, Texas 77204
Principal Investigator: Daniel Powell, OD, PhD
Phone: 713-743-2736
572
mi
from
Houston, TX
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Indianapolis, Indiana 46260
Principal Investigator: Kathleen Kelley, OD
Phone: 317-814-2996
643
mi
from
Indianapolis, IN
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Irvine, California 92697
Principal Investigator: Marjan Farid, MD
Phone: 714-456-7741
1156
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from
Irvine, CA
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Jonesboro, Arkansas 72401
Principal Investigator: Thomas Nix
Phone: 870-934-5210
416
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from
Jonesboro, AR
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Kansas City, Missouri 64111
Principal Investigator: Joseph Tauber, MD
Phone: 816-531-9100
196
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from
Kansas City, MO
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Kingston, Pennsylvania 18704
Principal Investigator: Harvey J Reiser, MD
Phone: 570-714-5910
1190
mi
from
Kingston, PA
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Lake Jackson, Texas 77566
Principal Investigator: Jonathan P. Grady, MD
Phone: 979-297-2961
615
mi
from
Lake Jackson, TX
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Lakeland, Florida 33805
Principal Investigator: Jay Mulaney, MD
Phone: 863-686-1010
1135
mi
from
Lakeland, FL
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Largo, Florida
Principal Investigator: Philip L Shettle, DO
Phone: 727-674-2500
1103
mi
from
Largo, FL
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Las Vegas, Nevada 89148
Principal Investigator: Jack Abrams, MD
Phone: 702-515-9648
970
mi
from
Las Vegas, NV
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Lexington, Kentucky 40509
Principal Investigator: Bruce Koffler, MD
Phone: 859-263-4631
725
mi
from
Lexington, KY
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Los Angeles, California
Principal Investigator: Jonathan Macy, MD
Phone: 310-657-2777
1168
mi
from
Los Angeles, CA
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Los Angeles, California 90067
Principal Investigator: Nicole Fram, MD
Phone: 310-229-1220
1168
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Los Angeles, CA
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Louisville, Kentucky 40217
Principal Investigator: Gregory Sulkowski, MD
Phone: 502-458-9004
658
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from
Louisville, KY
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Louisville, Kentucky 40206
Principal Investigator: John Meyer, MD
Phone: 502-589-1500
660
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from
Louisville, KY
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Memphis, Tennessee
Principal Investigator: David Evans, OD
Phone: 901-761-4620
467
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from
Memphis, TN
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Mission Hills, California
Principal Investigator: Steven Rauchman, MD
Phone: 818-365-0606
1176
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from
Mission Hills, CA
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Morgantown, West Virginia 26505
Principal Investigator: Heath Lemley, MD
Phone: 304-598-3301
970
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Morgantown, WV
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Morrow, Georgia 30260
Principal Investigator: Harvey DuBiner, MD
Phone: 770-968-8888
808
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from
Morrow, GA
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Nashville, Tennessee 37203
Principal Investigator: Melissa Toyos, MD
Phone: 615-327-4015
618
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Nashville, TN
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New Albany, Indiana 47150
Principal Investigator: Steve Wilson, OD
Phone: 812-948-0616
653
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from
New Albany, IN
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New York, New York 10013
Principal Investigator: Raymond Fong, MD
Phone: 212-274-1900
1286
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from
New York, NY
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Newport Beach, California
Principal Investigator: David Wirta, MD
Phone: 949-650-1863
1161
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from
Newport Beach, CA
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Norfolk, Virginia 23502
Principal Investigator: John Sheppard, MD
Phone: 757-961-2948
1186
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Norfolk, VA
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Ormond Beach, Florida 32174
Principal Investigator: Mark Rubin, MD
1126
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from
Ormond Beach, FL
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Poway, California 92064
Principal Investigator: Jeffrey Lozier, MD
Phone: 858-613-2965
1129
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from
Poway, CA
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Redding, California
Principal Investigator: Bruce E Silverstein, MD
Phone: 530-223-2500
1326
mi
from
Redding, CA
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Rockville Centre, New York 11570
Principal Investigator: Henry Perry, MD
Phone: 516-705-7140
1305
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Rockville Centre, NY
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9911 Kennerly Road
Saint Louis, Missouri 63128
407
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Saint Louis, MO
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San Antonio, Texas 78230
Principal Investigator: John Kozlovsky, MD
Phone: 210-541-0123
576
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from
San Antonio, TX
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San Diego, California
Principal Investigator: Barry Katzman, MD
Phone: 619-697-4600
1143
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from
San Diego, CA
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Spokane, Washington 99204
Principal Investigator: Randall Jacobson, MD
Phone: 509-623-9768
1201
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Spokane, WA
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Tampa, Florida 33603
Principal Investigator: Bernard Perez, MD
Phone: 813-875-6588
1115
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Tampa, FL
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Torrance, California 90505
Principal Investigator: Damien Goldberg, MD
Phone: 310-602-5640
1179
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Torrance, CA
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Washington, Missouri 63090
Principal Investigator: Michael Korenfeld, MD
Phone: 636-390-3999
374
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Washington, MO
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Westerville, Ohio 43082
Principal Investigator: Kenneth Beckman, MD
Phone: 614-890-5692
815
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Westerville, OH
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Westminster, California 92683
Principal Investigator: Michael Tran, MD
Phone: 714-839-2077
1161
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Westminster, CA
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Wilkes-Barre, Pennsylvania 18702
Principal Investigator: Frank Bucci, MD
Phone: 570-270-5281
1191
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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
978
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Winston-Salem, NC
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