Safety and Efficacy of KPI-121 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:October 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
60
sites
Memphis, Tennessee
508
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from 43215
Memphis, TN
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Albany, Georgia 31701
Principal Investigator: El-Roy Dixon, MD
Phone: 229-439-7700
582
mi
from 43215
Albany, GA
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Artesia, California 90701
Principal Investigator: Kenneth Sall, MD
Phone: 562-804-1974
1968
mi
from 43215
Artesia, CA
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Bloomington, Minnesota 55420
Principal Investigator: Y. Ralph Chu, MD
Phone: 952-835-1235
622
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from 43215
Bloomington, MN
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Boynton Beach, Florida
Principal Investigator: Barry Schechter, MD
Phone: 561-737-5500
943
mi
from 43215
Boynton Beach, FL
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Cedar Park, Texas 78613
Principal Investigator: Vincent Restivo, Jr., MD
Phone: 512-528-1144
1057
mi
from 43215
Cedar Park, TX
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Charlotte, North Carolina
Principal Investigator: Thomas Mundorf, MD
Phone: 704-334-3222
348
mi
from 43215
Charlotte, NC
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Chesterfield, Missouri 63017
Principal Investigator: Mujtaba Qazi, MD
Phone: 636-534-5126
413
mi
from 43215
Chesterfield, MO
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Cleveland, Ohio 44115
Principal Investigator: Marc Abrams, MD
Phone: 216-937-2020
127
mi
from 43215
Cleveland, OH
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Columbus, Ohio 43215
Principal Investigator: Alice Epitropoulos, MD
Phone: 614-221-7464
1
mi
from 43215
Columbus, OH
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Cranberry Township, Pennsylvania 16066
Principal Investigator: Daniel Zimmer, MD
Phone: 724-772-5420
161
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from 43215
Cranberry Township, PA
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Durham, North Carolina 27704
Principal Investigator: Asra Firozvi, MD
Phone: 919-595-2039
354
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from 43215
Durham, NC
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Fargo, North Dakota 58103
Principal Investigator: Lance Bergstrom, MD
Phone: 701-478-0061
837
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from 43215
Fargo, ND
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Fort Collins, Colorado 80525
Principal Investigator: Benjamin Marske, OD
Phone: 970-221-2222
1159
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Fort Collins, CO
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Fort Myers, Florida 33901
Principal Investigator: Stephen E Smith, MD
Phone: 239-939-0413
924
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Fort Myers, FL
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12665 Garden Grove Boulevard
Garden Grove, California 92843
1961
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from 43215
Garden Grove, CA
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Hamden, Connecticut 06518
Principal Investigator: Mark Milner, MD
Phone: 203-248-6365
538
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from 43215
Hamden, CT
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Houston, Texas 77025
Principal Investigator: John Goosey, MD
Phone: 832-280-3635
997
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from 43215
Houston, TX
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Indianapolis, Indiana 46290
Principal Investigator: Clark Springs, MD
Phone: 317-805-4527
166
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from 43215
Indianapolis, IN
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Inglewood, California 90301
Principal Investigator: James H Peace, MD
Phone: 310-671-7172
1980
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Inglewood, CA
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Lake Villa, Illinois 60046
Principal Investigator: Mitchell A Jackson, MD
Phone: 847-356-0700
312
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from 43215
Lake Villa, IL
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Lancaster, Pennsylvania 17601
Principal Investigator: David Silbert, MD, FAAP
Phone: 717-541-9700
355
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Lancaster, PA
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Largo, Florida
Principal Investigator: Phillip Shettle, DO
Phone: 727-674-2500
833
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Largo, FL
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Las Vegas, Nevada 89119
Principal Investigator: Kent Wellish, MD
Phone: 702-932-4270
1756
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Las Vegas, NV
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Layton, Utah 84041
Principal Investigator: Trent Richards, MD
Phone: 801-773-4840
1515
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Layton, UT
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League City, Texas 77573
Principal Investigator: Da-Thuy Van, DO
Phone: 281-332-3937
993
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League City, TX
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Leander, Texas 78641
Principal Investigator: Kyle Rhodes, MD
Phone: 512-528-5795
1055
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Leander, TX
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Little Rock, Arkansas 72205
Principal Investigator: Robert L Berry, MD
Phone: 501-225-4488
625
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Little Rock, AR
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Little Rock, Arkansas 72205
Principal Investigator: Laurie Barber, MD
Phone: 501-224-5658
623
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Little Rock, AR
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Littleton, Colorado
Principal Investigator: S. Lance Forstot, MD
Phone: 303-730-0404
1164
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Littleton, CO
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Mason, Ohio 45040
Principal Investigator: Edward Meier, MD
Phone: 513-770-4020
80
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Mason, OH
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McLean, Virginia 22102
Principal Investigator: Khoa Hoang, MD
Phone: 703-287-4125
319
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from 43215
McLean, VA
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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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Montebello, California 90640
Principal Investigator: Reginald Sampson, MD
Phone: 323-728-7998
1966
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from 43215
Montebello, CA
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40700 California Oaks Road
Murrieta, California 92562
1930
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Murrieta, CA
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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: Elizabeth Yeu, MD
Phone: 757-622-2200
426
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Norfolk, VA
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Oceanside, California 92056
Principal Investigator: Robert B. Pendleton, MD, PhD
Phone: 760-758-2008
1945
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Oceanside, CA
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Overland Park, Kansas 66213
Principal Investigator: Michael Stiles, MD
Phone: 913-681-1601
624
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Overland Park, KS
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Palm Coast, Florida 32137
Principal Investigator: Alexandra Kostick, MD
Phone: 386-446-9590
724
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Palm Coast, FL
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Panama City, Florida 32405
Principal Investigator: Bret Fisher, MD
Phone: 850-784-3937
691
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Pennington, New Jersey 08534
Principal Investigator: Cynthia Matossian, MD, FACS
Phone: 609-323-1560
435
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Pennington, NJ
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Petaluma, California 94954
Principal Investigator: Jason Bacharach, MD
2108
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Petaluma, CA
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Phoenix, Arizona 85032
Principal Investigator: Robert H Gross, MD
Phone: 602-258-4342
1654
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Pittsburgh, Pennsylvania 15213
Principal Investigator: Deepinder Dhaliwal, MD
Phone: 412-383-9033
165
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Pittsburgh, PA
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Raleigh, North Carolina 27603
Principal Investigator: Carol Aune, OD
Phone: 919-362-6882
375
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Raleigh, NC
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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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Rapid City, South Dakota 57701
Principal Investigator: Terrence Spencer, MD
Phone: 605-719-3153
1071
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Rapid City, SD
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Rochester, New York 14618
Principal Investigator: Paul Hartman, MD
Phone: 585-244-6011
355
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Rochester, NY
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Roseburg, Oregon 97471
Principal Investigator: Jon-Marc Weston, MD
Phone: 541-672-2020
2075
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Roseburg, OR
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Sacramento, California 95815
Principal Investigator: Patricia Sierra, MD
Phone: 916-649-1515
2040
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Sacramento, CA
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Saint Louis, Missouri 63141
408
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Saint Louis, MO
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Saint Louis, Missouri 63131
407
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Saint Louis, MO
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San Antonio, Texas 78209
Principal Investigator: Jay Rubin, MD
Phone: 210-826-2012
1135
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San Antonio, TX
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San Antonio, Texas 78229
Principal Investigator: Robert Rice, MD
Phone: 210-424-2584
1138
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San Antonio, Texas 78240
Principal Investigator: Richard Evans, MD
Phone: 210-696-9706
1138
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San Antonio, TX
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8416 E. Shea Blvd., Ste C-101
Scottsdale, Arizona 85260
Principal Investigator: Jay Schwartz, DO
Phone: 480-483-3937
1653
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Scottsdale, AZ
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Slingerlands, New York 12159
Principal Investigator: Robert Schultze, MD
Phone: 518-475-1515
509
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Slingerlands, NY
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Wantagh, New York 11793
Principal Investigator: Jodi Luchs, MD
Phone: 516-785-3900
503
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Wantagh, NY
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Winchester, Massachusetts 01890
Principal Investigator: Jack Greiner, OD, PhD
Phone: 781-729-3008
640
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Winchester, MA
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