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 |
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).
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.
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
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Artesia, California 90701
Principal Investigator: Kenneth Sall, MD
Phone: 562-804-1974
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Bloomington, Minnesota 55420
Principal Investigator: Y. Ralph Chu, MD
Phone: 952-835-1235
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Boynton Beach, Florida
Principal Investigator: Barry Schechter, MD
Phone: 561-737-5500
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Cedar Park, Texas 78613
Principal Investigator: Vincent Restivo, Jr., MD
Phone: 512-528-1144
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Charlotte, North Carolina
Principal Investigator: Thomas Mundorf, MD
Phone: 704-334-3222
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Chesterfield, Missouri 63017
Principal Investigator: Mujtaba Qazi, MD
Phone: 636-534-5126
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Columbus, Ohio 43215
Principal Investigator: Alice Epitropoulos, MD
Phone: 614-221-7464
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Cranberry Township, Pennsylvania 16066
Principal Investigator: Daniel Zimmer, MD
Phone: 724-772-5420
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Durham, North Carolina 27704
Principal Investigator: Asra Firozvi, MD
Phone: 919-595-2039
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Fargo, North Dakota 58103
Principal Investigator: Lance Bergstrom, MD
Phone: 701-478-0061
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Fort Collins, Colorado 80525
Principal Investigator: Benjamin Marske, OD
Phone: 970-221-2222
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Fort Myers, Florida 33901
Principal Investigator: Stephen E Smith, MD
Phone: 239-939-0413
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12665 Garden Grove Boulevard
Garden Grove, California 92843
Garden Grove, California 92843
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Hamden, Connecticut 06518
Principal Investigator: Mark Milner, MD
Phone: 203-248-6365
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Houston, Texas 77025
Principal Investigator: John Goosey, MD
Phone: 832-280-3635
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Indianapolis, Indiana 46290
Principal Investigator: Clark Springs, MD
Phone: 317-805-4527
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Inglewood, California 90301
Principal Investigator: James H Peace, MD
Phone: 310-671-7172
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Lake Villa, Illinois 60046
Principal Investigator: Mitchell A Jackson, MD
Phone: 847-356-0700
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Lancaster, Pennsylvania 17601
Principal Investigator: David Silbert, MD, FAAP
Phone: 717-541-9700
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Las Vegas, Nevada 89119
Principal Investigator: Kent Wellish, MD
Phone: 702-932-4270
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League City, Texas 77573
Principal Investigator: Da-Thuy Van, DO
Phone: 281-332-3937
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Leander, Texas 78641
Principal Investigator: Kyle Rhodes, MD
Phone: 512-528-5795
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Little Rock, Arkansas 72205
Principal Investigator: Robert L Berry, MD
Phone: 501-225-4488
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Little Rock, Arkansas 72205
Principal Investigator: Laurie Barber, MD
Phone: 501-224-5658
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Littleton, Colorado
Principal Investigator: S. Lance Forstot, MD
Phone: 303-730-0404
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McLean, Virginia 22102
Principal Investigator: Khoa Hoang, MD
Phone: 703-287-4125
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Mission Hills, California
Principal Investigator: Steven Rauchman, MD
Phone: 818-365-0606
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Montebello, California 90640
Principal Investigator: Reginald Sampson, MD
Phone: 323-728-7998
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Newport Beach, California
Principal Investigator: David Wirta, MD
Phone: 949-650-1863
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Norfolk, Virginia 23502
Principal Investigator: Elizabeth Yeu, MD
Phone: 757-622-2200
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Oceanside, California 92056
Principal Investigator: Robert B. Pendleton, MD, PhD
Phone: 760-758-2008
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Overland Park, Kansas 66213
Principal Investigator: Michael Stiles, MD
Phone: 913-681-1601
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Palm Coast, Florida 32137
Principal Investigator: Alexandra Kostick, MD
Phone: 386-446-9590
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Panama City, Florida 32405
Principal Investigator: Bret Fisher, MD
Phone: 850-784-3937
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Pennington, New Jersey 08534
Principal Investigator: Cynthia Matossian, MD, FACS
Phone: 609-323-1560
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Phoenix, Arizona 85032
Principal Investigator: Robert H Gross, MD
Phone: 602-258-4342
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Pittsburgh, Pennsylvania 15213
Principal Investigator: Deepinder Dhaliwal, MD
Phone: 412-383-9033
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Raleigh, North Carolina 27603
Principal Investigator: Carol Aune, OD
Phone: 919-362-6882
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Rancho Cordova, California 95670
Principal Investigator: Joseph R Martel, MD
Phone: 916-631-7860
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Rapid City, South Dakota 57701
Principal Investigator: Terrence Spencer, MD
Phone: 605-719-3153
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Rochester, New York 14618
Principal Investigator: Paul Hartman, MD
Phone: 585-244-6011
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Roseburg, Oregon 97471
Principal Investigator: Jon-Marc Weston, MD
Phone: 541-672-2020
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Sacramento, California 95815
Principal Investigator: Patricia Sierra, MD
Phone: 916-649-1515
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San Antonio, Texas 78209
Principal Investigator: Jay Rubin, MD
Phone: 210-826-2012
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San Antonio, Texas 78229
Principal Investigator: Robert Rice, MD
Phone: 210-424-2584
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San Antonio, Texas 78240
Principal Investigator: Richard Evans, MD
Phone: 210-696-9706
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8416 E. Shea Blvd., Ste C-101
Scottsdale, Arizona 85260
Scottsdale, Arizona 85260
Principal Investigator: Jay Schwartz, DO
Phone: 480-483-3937
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Slingerlands, New York 12159
Principal Investigator: Robert Schultze, MD
Phone: 518-475-1515
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Wantagh, New York 11793
Principal Investigator: Jodi Luchs, MD
Phone: 516-785-3900
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Winchester, Massachusetts 01890
Principal Investigator: Jack Greiner, OD, PhD
Phone: 781-729-3008
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