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 |
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
62
sites
Rancho Cordova, California 95670
Principal Investigator: Joseph R Martel, MD
Phone: 916-631-7860
Click here to add this to my saved trials

Artesia, California 90701
Principal Investigator: Kenneth Sall, MD
Phone: 562-804-1974
Click here to add this to my saved trials

Austin, Texas 78731
Principal Investigator: Yen Nieman, MD
Phone: 512-451-4400
Click here to add this to my saved trials

Azusa, California 91702
Principal Investigator: Milton M Hom, OD
Phone: 626-963-7100
Click here to add this to my saved trials

Birmingham, Alabama 35294
Principal Investigator: Kelly Nichols, OD, PhD
Phone: 205-934-6763
Click here to add this to my saved trials

Bloomington, Minnesota 55431
Principal Investigator: David Hardten, MD
Phone: 952-567-6111
Click here to add this to my saved trials

Boston, Massachusetts 02114
Principal Investigator: Jason Rothman, MD
Phone: 617-314-2703
Click here to add this to my saved trials

Brooksville, Florida 34613
Principal Investigator: Leonard Cacioppo, MD
Phone: 352-596-4030
Click here to add this to my saved trials

Campbell, California 95008
Principal Investigator: Larry Wan, OD
Phone: 408-866-2020
Click here to add this to my saved trials

Chandler, Arizona
Principal Investigator: Michael Depenbusch, MD
Phone: 480-999-5458
Click here to add this to my saved trials

Chattanooga, Tennessee 37411
Principal Investigator: Charles Kirby, MD
Phone: 423-892-3937
Click here to add this to my saved trials

Cranberry Township, Pennsylvania 16066
Principal Investigator: Daniel Zimmer, MD
Phone: 724-772-5420
Click here to add this to my saved trials

Click here to add this to my saved trials

Edgewood, Kentucky 41017
Principal Investigator: Brad Genereux, OD
Phone: 859-331-9000
Click here to add this to my saved trials

El Paso, Texas 79902
Principal Investigator: Louis Alpern, MD
Phone: 915-545-2333
Click here to add this to my saved trials

Eugene, Oregon 97401
Principal Investigator: Annette Sims, MD
Phone: 541-687-2110
Click here to add this to my saved trials

Garden Grove, California 92843
Principal Investigator: James Boyce, MD
Phone: 714-534-8373
Click here to add this to my saved trials

Glendale, California 91205
Principal Investigator: Sherif M El-Harazi, MD
Phone: 818-246-2560
Click here to add this to my saved trials

High Point, North Carolina 27262
Principal Investigator: Robert DaVanzo, MD
Phone: 336-802-2255
Click here to add this to my saved trials

Hoffman Estates, Illinois
Principal Investigator: Parag Majmudar, MD
Phone: 847-748-3553
Click here to add this to my saved trials

Houston, Texas 77025
Principal Investigator: Richard J Ou
Phone: 832-553-7140
Click here to add this to my saved trials

Houston, Texas 77055
Principal Investigator: Jeffrey Whitsett, MD
Phone: 713-365-9099
Click here to add this to my saved trials

Houston, Texas 77034
Principal Investigator: Nancy Stephens, OD
Phone: 281-338-0425
Click here to add this to my saved trials

Houston, Texas 77204
Principal Investigator: Daniel Powell, OD, PhD
Phone: 713-743-2736
Click here to add this to my saved trials

Indianapolis, Indiana 46260
Principal Investigator: Kathleen Kelley, OD
Phone: 317-814-2996
Click here to add this to my saved trials

Irvine, California 92697
Principal Investigator: Marjan Farid, MD
Phone: 714-456-7741
Click here to add this to my saved trials

Click here to add this to my saved trials

Kansas City, Missouri 64111
Principal Investigator: Joseph Tauber, MD
Phone: 816-531-9100
Click here to add this to my saved trials

Kingston, Pennsylvania 18704
Principal Investigator: Harvey J Reiser, MD
Phone: 570-714-5910
Click here to add this to my saved trials

Lake Jackson, Texas 77566
Principal Investigator: Jonathan P. Grady, MD
Phone: 979-297-2961
Click here to add this to my saved trials

Lakeland, Florida 33805
Principal Investigator: Jay Mulaney, MD
Phone: 863-686-1010
Click here to add this to my saved trials

Largo, Florida
Principal Investigator: Philip L Shettle, DO
Phone: 727-674-2500
Click here to add this to my saved trials

Las Vegas, Nevada 89148
Principal Investigator: Jack Abrams, MD
Phone: 702-515-9648
Click here to add this to my saved trials

Lexington, Kentucky 40509
Principal Investigator: Bruce Koffler, MD
Phone: 859-263-4631
Click here to add this to my saved trials

Los Angeles, California
Principal Investigator: Jonathan Macy, MD
Phone: 310-657-2777
Click here to add this to my saved trials

Los Angeles, California 90067
Principal Investigator: Nicole Fram, MD
Phone: 310-229-1220
Click here to add this to my saved trials

Louisville, Kentucky 40217
Principal Investigator: Gregory Sulkowski, MD
Phone: 502-458-9004
Click here to add this to my saved trials

Louisville, Kentucky 40206
Principal Investigator: John Meyer, MD
Phone: 502-589-1500
Click here to add this to my saved trials

Click here to add this to my saved trials

Mission Hills, California
Principal Investigator: Steven Rauchman, MD
Phone: 818-365-0606
Click here to add this to my saved trials

Morgantown, West Virginia 26505
Principal Investigator: Heath Lemley, MD
Phone: 304-598-3301
Click here to add this to my saved trials

Morrow, Georgia 30260
Principal Investigator: Harvey DuBiner, MD
Phone: 770-968-8888
Click here to add this to my saved trials

Nashville, Tennessee 37203
Principal Investigator: Melissa Toyos, MD
Phone: 615-327-4015
Click here to add this to my saved trials

New Albany, Indiana 47150
Principal Investigator: Steve Wilson, OD
Phone: 812-948-0616
Click here to add this to my saved trials

New York, New York 10013
Principal Investigator: Raymond Fong, MD
Phone: 212-274-1900
Click here to add this to my saved trials

Newport Beach, California
Principal Investigator: David Wirta, MD
Phone: 949-650-1863
Click here to add this to my saved trials

Norfolk, Virginia 23502
Principal Investigator: John Sheppard, MD
Phone: 757-961-2948
Click here to add this to my saved trials

Click here to add this to my saved trials

Poway, California 92064
Principal Investigator: Jeffrey Lozier, MD
Phone: 858-613-2965
Click here to add this to my saved trials

Redding, California
Principal Investigator: Bruce E Silverstein, MD
Phone: 530-223-2500
Click here to add this to my saved trials

Rockville Centre, New York 11570
Principal Investigator: Henry Perry, MD
Phone: 516-705-7140
Click here to add this to my saved trials

Click here to add this to my saved trials

San Antonio, Texas 78230
Principal Investigator: John Kozlovsky, MD
Phone: 210-541-0123
Click here to add this to my saved trials

San Diego, California
Principal Investigator: Barry Katzman, MD
Phone: 619-697-4600
Click here to add this to my saved trials

Spokane, Washington 99204
Principal Investigator: Randall Jacobson, MD
Phone: 509-623-9768
Click here to add this to my saved trials

Tampa, Florida 33603
Principal Investigator: Bernard Perez, MD
Phone: 813-875-6588
Click here to add this to my saved trials

Torrance, California 90505
Principal Investigator: Damien Goldberg, MD
Phone: 310-602-5640
Click here to add this to my saved trials

Washington, Missouri 63090
Principal Investigator: Michael Korenfeld, MD
Phone: 636-390-3999
Click here to add this to my saved trials

Westerville, Ohio 43082
Principal Investigator: Kenneth Beckman, MD
Phone: 614-890-5692
Click here to add this to my saved trials

Westminster, California 92683
Principal Investigator: Michael Tran, MD
Phone: 714-839-2077
Click here to add this to my saved trials

Wilkes-Barre, Pennsylvania 18702
Principal Investigator: Frank Bucci, MD
Phone: 570-270-5281
Click here to add this to my saved trials

Winston-Salem, North Carolina 27101
Principal Investigator: James D Branch, MD
Phone: 336-723-0748
Click here to add this to my saved trials
