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
1864
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from 98109
Memphis, TN
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Albany, Georgia 31701
Principal Investigator: El-Roy Dixon, MD
Phone: 229-439-7700
2283
mi
from 98109
Albany, GA
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Artesia, California 90701
Principal Investigator: Kenneth Sall, MD
Phone: 562-804-1974
976
mi
from 98109
Artesia, CA
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Bloomington, Minnesota 55420
Principal Investigator: Y. Ralph Chu, MD
Phone: 952-835-1235
1393
mi
from 98109
Bloomington, MN
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Boynton Beach, Florida
Principal Investigator: Barry Schechter, MD
Phone: 561-737-5500
2701
mi
from 98109
Boynton Beach, FL
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Cedar Park, Texas 78613
Principal Investigator: Vincent Restivo, Jr., MD
Phone: 512-528-1144
1755
mi
from 98109
Cedar Park, TX
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Charlotte, North Carolina
Principal Investigator: Thomas Mundorf, MD
Phone: 704-334-3222
2281
mi
from 98109
Charlotte, NC
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Chesterfield, Missouri 63017
Principal Investigator: Mujtaba Qazi, MD
Phone: 636-534-5126
1702
mi
from 98109
Chesterfield, MO
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Cleveland, Ohio 44115
Principal Investigator: Marc Abrams, MD
Phone: 216-937-2020
2022
mi
from 98109
Cleveland, OH
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Columbus, Ohio 43215
Principal Investigator: Alice Epitropoulos, MD
Phone: 614-221-7464
2008
mi
from 98109
Columbus, OH
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Cranberry Township, Pennsylvania 16066
Principal Investigator: Daniel Zimmer, MD
Phone: 724-772-5420
2119
mi
from 98109
Cranberry Township, PA
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Durham, North Carolina 27704
Principal Investigator: Asra Firozvi, MD
Phone: 919-595-2039
2341
mi
from 98109
Durham, NC
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Fargo, North Dakota 58103
Principal Investigator: Lance Bergstrom, MD
Phone: 701-478-0061
1193
mi
from 98109
Fargo, ND
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Fort Collins, Colorado 80525
Principal Investigator: Benjamin Marske, OD
Phone: 970-221-2222
985
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from 98109
Fort Collins, CO
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Fort Myers, Florida 33901
Principal Investigator: Stephen E Smith, MD
Phone: 239-939-0413
2616
mi
from 98109
Fort Myers, FL
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12665 Garden Grove Boulevard
Garden Grove, California 92843
984
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from 98109
Garden Grove, CA
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Hamden, Connecticut 06518
Principal Investigator: Mark Milner, MD
Phone: 203-248-6365
2429
mi
from 98109
Hamden, CT
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Houston, Texas 77025
Principal Investigator: John Goosey, MD
Phone: 832-280-3635
1891
mi
from 98109
Houston, TX
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Indianapolis, Indiana 46290
Principal Investigator: Clark Springs, MD
Phone: 317-805-4527
1868
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from 98109
Indianapolis, IN
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Inglewood, California 90301
Principal Investigator: James H Peace, MD
Phone: 310-671-7172
967
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from 98109
Inglewood, CA
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Lake Villa, Illinois 60046
Principal Investigator: Mitchell A Jackson, MD
Phone: 847-356-0700
1697
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from 98109
Lake Villa, IL
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Lancaster, Pennsylvania 17601
Principal Investigator: David Silbert, MD, FAAP
Phone: 717-541-9700
2317
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from 98109
Lancaster, PA
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Largo, Florida
Principal Investigator: Phillip Shettle, DO
Phone: 727-674-2500
2514
mi
from 98109
Largo, FL
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Las Vegas, Nevada 89119
Principal Investigator: Kent Wellish, MD
Phone: 702-932-4270
873
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from 98109
Las Vegas, NV
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Layton, Utah 84041
Principal Investigator: Trent Richards, MD
Phone: 801-773-4840
682
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from 98109
Layton, UT
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League City, Texas 77573
Principal Investigator: Da-Thuy Van, DO
Phone: 281-332-3937
1914
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from 98109
League City, TX
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Leander, Texas 78641
Principal Investigator: Kyle Rhodes, MD
Phone: 512-528-5795
1750
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from 98109
Leander, TX
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Little Rock, Arkansas 72205
Principal Investigator: Robert L Berry, MD
Phone: 501-225-4488
1779
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from 98109
Little Rock, AR
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Little Rock, Arkansas 72205
Principal Investigator: Laurie Barber, MD
Phone: 501-224-5658
1782
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from 98109
Little Rock, AR
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Littleton, Colorado
Principal Investigator: S. Lance Forstot, MD
Phone: 303-730-0404
1024
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from 98109
Littleton, CO
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Mason, Ohio 45040
Principal Investigator: Edward Meier, MD
Phone: 513-770-4020
1967
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from 98109
Mason, OH
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McLean, Virginia 22102
Principal Investigator: Khoa Hoang, MD
Phone: 703-287-4125
2314
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from 98109
McLean, VA
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Mission Hills, California
Principal Investigator: Steven Rauchman, MD
Phone: 818-365-0606
944
mi
from 98109
Mission Hills, CA
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Montebello, California 90640
Principal Investigator: Reginald Sampson, MD
Phone: 323-728-7998
966
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from 98109
Montebello, CA
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40700 California Oaks Road
Murrieta, California 92562
1007
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Murrieta, CA
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Newport Beach, California
Principal Investigator: David Wirta, MD
Phone: 949-650-1863
995
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from 98109
Newport Beach, CA
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Norfolk, Virginia 23502
Principal Investigator: Elizabeth Yeu, MD
Phone: 757-622-2200
2434
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Norfolk, VA
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Oceanside, California 92056
Principal Investigator: Robert B. Pendleton, MD, PhD
Phone: 760-758-2008
1031
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Oceanside, CA
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Overland Park, Kansas 66213
Principal Investigator: Michael Stiles, MD
Phone: 913-681-1601
1503
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Overland Park, KS
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Palm Coast, Florida 32137
Principal Investigator: Alexandra Kostick, MD
Phone: 386-446-9590
2506
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Palm Coast, FL
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Panama City, Florida 32405
Principal Investigator: Bret Fisher, MD
Phone: 850-784-3937
2279
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Panama City, FL
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Pennington, New Jersey 08534
Principal Investigator: Cynthia Matossian, MD, FACS
Phone: 609-323-1560
2378
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Pennington, NJ
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Petaluma, California 94954
Principal Investigator: Jason Bacharach, MD
648
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Petaluma, CA
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Phoenix, Arizona 85032
Principal Investigator: Robert H Gross, MD
Phone: 602-258-4342
1106
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Phoenix, AZ
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Pittsburgh, Pennsylvania 15213
Principal Investigator: Deepinder Dhaliwal, MD
Phone: 412-383-9033
2134
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Pittsburgh, PA
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Raleigh, North Carolina 27603
Principal Investigator: Carol Aune, OD
Phone: 919-362-6882
2362
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from 98109
Raleigh, NC
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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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Rapid City, South Dakota 57701
Principal Investigator: Terrence Spencer, MD
Phone: 605-719-3153
949
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Rapid City, SD
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Rochester, New York 14618
Principal Investigator: Paul Hartman, MD
Phone: 585-244-6011
2161
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Rochester, NY
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Roseburg, Oregon 97471
Principal Investigator: Jon-Marc Weston, MD
Phone: 541-672-2020
309
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Roseburg, OR
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Sacramento, California 95815
Principal Investigator: Patricia Sierra, MD
Phone: 916-649-1515
626
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from 98109
Sacramento, CA
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Saint Louis, Missouri 63141
1706
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from 98109
Saint Louis, MO
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Saint Louis, Missouri 63131
1710
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Saint Louis, MO
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San Antonio, Texas 78209
Principal Investigator: Jay Rubin, MD
Phone: 210-826-2012
1784
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San Antonio, TX
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San Antonio, Texas 78229
Principal Investigator: Robert Rice, MD
Phone: 210-424-2584
1779
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San Antonio, TX
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San Antonio, Texas 78240
Principal Investigator: Richard Evans, MD
Phone: 210-696-9706
1787
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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
1117
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Scottsdale, AZ
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Slingerlands, New York 12159
Principal Investigator: Robert Schultze, MD
Phone: 518-475-1515
2348
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Slingerlands, NY
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Wantagh, New York 11793
Principal Investigator: Jodi Luchs, MD
Phone: 516-785-3900
2425
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Wantagh, NY
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Winchester, Massachusetts 01890
Principal Investigator: Jack Greiner, OD, PhD
Phone: 781-729-3008
2479
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Winchester, MA
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