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
2033
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Rancho Cordova, CA
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Artesia, California 90701
Principal Investigator: Kenneth Sall, MD
Phone: 562-804-1974
1968
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from 43215
Artesia, CA
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Austin, Texas 78731
Principal Investigator: Yen Nieman, MD
Phone: 512-451-4400
1062
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from 43215
Austin, TX
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Azusa, California 91702
Principal Investigator: Milton M Hom, OD
Phone: 626-963-7100
1952
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from 43215
Azusa, CA
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Birmingham, Alabama 35294
Principal Investigator: Kelly Nichols, OD, PhD
Phone: 205-934-6763
492
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from 43215
Birmingham, AL
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Bloomington, Minnesota 55431
Principal Investigator: David Hardten, MD
Phone: 952-567-6111
622
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from 43215
Bloomington, MN
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Boston, Massachusetts 02114
Principal Investigator: Jason Rothman, MD
Phone: 617-314-2703
643
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from 43215
Boston, MA
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Brooksville, Florida 34613
Principal Investigator: Leonard Cacioppo, MD
Phone: 352-596-4030
789
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Brooksville, FL
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Campbell, California 95008
Principal Investigator: Larry Wan, OD
Phone: 408-866-2020
2092
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Campbell, CA
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Chandler, Arizona
Principal Investigator: Michael Depenbusch, MD
Phone: 480-999-5458
1654
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Chandler, AZ
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Chattanooga, Tennessee 37411
Principal Investigator: Charles Kirby, MD
Phone: 423-892-3937
355
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Chattanooga, TN
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Cranberry Township, Pennsylvania 16066
Principal Investigator: Daniel Zimmer, MD
Phone: 724-772-5420
161
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Cranberry Township, PA
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Draper, Utah 84020
Principal Investigator: Majid Moshirfar, MD
Phone: 801-568-0200
1515
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Draper, UT
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Edgewood, Kentucky 41017
Principal Investigator: Brad Genereux, OD
Phone: 859-331-9000
105
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Edgewood, KY
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El Paso, Texas 79902
Principal Investigator: Louis Alpern, MD
Phone: 915-545-2333
1425
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El Paso, TX
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Eugene, Oregon 97401
Principal Investigator: Annette Sims, MD
Phone: 541-687-2110
2055
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Eugene, OR
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Garden Grove, California 92843
Principal Investigator: James Boyce, MD
Phone: 714-534-8373
1963
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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
1969
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Glendale, CA
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High Point, North Carolina 27262
Principal Investigator: Robert DaVanzo, MD
Phone: 336-802-2255
321
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High Point, NC
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Hoffman Estates, Illinois
Principal Investigator: Parag Majmudar, MD
Phone: 847-748-3553
302
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Hoffman Estates, IL
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Houston, Texas 77025
Principal Investigator: Richard J Ou
Phone: 832-553-7140
997
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Houston, TX
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Houston, Texas 77055
Principal Investigator: Jeffrey Whitsett, MD
Phone: 713-365-9099
994
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Houston, TX
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Houston, Texas 77034
Principal Investigator: Nancy Stephens, OD
Phone: 281-338-0425
992
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Houston, TX
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Houston, Texas 77204
Principal Investigator: Daniel Powell, OD, PhD
Phone: 713-743-2736
992
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Houston, TX
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Indianapolis, Indiana 46260
Principal Investigator: Kathleen Kelley, OD
Phone: 317-814-2996
167
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Indianapolis, IN
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Irvine, California 92697
Principal Investigator: Marjan Farid, MD
Phone: 714-456-7741
1961
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Irvine, CA
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Jonesboro, Arkansas 72401
Principal Investigator: Thomas Nix
Phone: 870-934-5210
505
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Jonesboro, AR
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Kansas City, Missouri 64111
Principal Investigator: Joseph Tauber, MD
Phone: 816-531-9100
619
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Kansas City, MO
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Kingston, Pennsylvania 18704
Principal Investigator: Harvey J Reiser, MD
Phone: 570-714-5910
384
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Kingston, PA
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Lake Jackson, Texas 77566
Principal Investigator: Jonathan P. Grady, MD
Phone: 979-297-2961
1032
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Lake Jackson, TX
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Lakeland, Florida 33805
Principal Investigator: Jay Mulaney, MD
Phone: 863-686-1010
822
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Lakeland, FL
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Largo, Florida
Principal Investigator: Philip L Shettle, DO
Phone: 727-674-2500
833
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Largo, FL
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Las Vegas, Nevada 89148
Principal Investigator: Jack Abrams, MD
Phone: 702-515-9648
1767
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Las Vegas, NV
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Lexington, Kentucky 40509
Principal Investigator: Bruce Koffler, MD
Phone: 859-263-4631
154
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Lexington, KY
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Los Angeles, California
Principal Investigator: Jonathan Macy, MD
Phone: 310-657-2777
1972
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Los Angeles, CA
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Los Angeles, California 90067
Principal Investigator: Nicole Fram, MD
Phone: 310-229-1220
1972
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Los Angeles, CA
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Louisville, Kentucky 40217
Principal Investigator: Gregory Sulkowski, MD
Phone: 502-458-9004
189
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Louisville, KY
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Louisville, Kentucky 40206
Principal Investigator: John Meyer, MD
Phone: 502-589-1500
185
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Louisville, KY
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Memphis, Tennessee
Principal Investigator: David Evans, OD
Phone: 901-761-4620
508
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Memphis, TN
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Mission Hills, California
Principal Investigator: Steven Rauchman, MD
Phone: 818-365-0606
1978
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Mission Hills, CA
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Morgantown, West Virginia 26505
Principal Investigator: Heath Lemley, MD
Phone: 304-598-3301
164
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Morgantown, WV
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Morrow, Georgia 30260
Principal Investigator: Harvey DuBiner, MD
Phone: 770-968-8888
446
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Morrow, GA
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Nashville, Tennessee 37203
Principal Investigator: Melissa Toyos, MD
Phone: 615-327-4015
333
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Nashville, TN
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New Albany, Indiana 47150
Principal Investigator: Steve Wilson, OD
Phone: 812-948-0616
189
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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
477
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New York, NY
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Newport Beach, California
Principal Investigator: David Wirta, MD
Phone: 949-650-1863
1967
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Newport Beach, CA
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Norfolk, Virginia 23502
Principal Investigator: John Sheppard, MD
Phone: 757-961-2948
426
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Norfolk, VA
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Ormond Beach, Florida 32174
Principal Investigator: Mark Rubin, MD
746
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Ormond Beach, FL
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Poway, California 92064
Principal Investigator: Jeffrey Lozier, MD
Phone: 858-613-2965
1938
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Poway, CA
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Redding, California
Principal Investigator: Bruce E Silverstein, MD
Phone: 530-223-2500
2058
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Redding, CA
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Rockville Centre, New York 11570
Principal Investigator: Henry Perry, MD
Phone: 516-705-7140
496
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Rockville Centre, NY
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9911 Kennerly Road
Saint Louis, Missouri 63128
405
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Saint Louis, MO
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San Antonio, Texas 78230
Principal Investigator: John Kozlovsky, MD
Phone: 210-541-0123
1138
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San Antonio, TX
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San Diego, California
Principal Investigator: Barry Katzman, MD
Phone: 619-697-4600
1951
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San Diego, CA
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Spokane, Washington 99204
Principal Investigator: Randall Jacobson, MD
Phone: 509-623-9768
1778
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Spokane, WA
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Tampa, Florida 33603
Principal Investigator: Bernard Perez, MD
Phone: 813-875-6588
828
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Tampa, FL
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Torrance, California 90505
Principal Investigator: Damien Goldberg, MD
Phone: 310-602-5640
1984
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Torrance, CA
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Washington, Missouri 63090
Principal Investigator: Michael Korenfeld, MD
Phone: 636-390-3999
438
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Washington, MO
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Westerville, Ohio 43082
Principal Investigator: Kenneth Beckman, MD
Phone: 614-890-5692
12
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Westerville, OH
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Westminster, California 92683
Principal Investigator: Michael Tran, MD
Phone: 714-839-2077
1966
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Westminster, CA
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Wilkes-Barre, Pennsylvania 18702
Principal Investigator: Frank Bucci, MD
Phone: 570-270-5281
385
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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
307
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Winston-Salem, NC
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