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).

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

sites

Bucci Laser Vision Institute

Wilkes-Barre, Pennsylvania 18702

Principal Investigator: Frank Bucci, MD

Phone: 570-270-5281

from

Wilkes-Barre, PA

Sall Research Medical Center, Inc.

Artesia, California 90701

Principal Investigator: Kenneth Sall, MD

Phone: 562-804-1974

from

Artesia, CA

Texan Eye/Keystone Research

Austin, Texas 78731

Principal Investigator: Yen Nieman, MD

Phone: 512-451-4400

from

Austin, TX

Milton M. Hom, OD, FAAO

Azusa, California 91702

Principal Investigator: Milton M Hom, OD

Phone: 626-963-7100

from

Azusa, CA

UAB School of Optometry

Birmingham, Alabama 35294

Principal Investigator: Kelly Nichols, OD, PhD

Phone: 205-934-6763

from

Birmingham, AL

Minnesota Eye Consultants

Bloomington, Minnesota 55431

Principal Investigator: David Hardten, MD

Phone: 952-567-6111

from

Bloomington, MN

Ophthalmic Consultants of Boston

Boston, Massachusetts 02114

Principal Investigator: Jason Rothman, MD

Phone: 617-314-2703

from

Boston, MA

Hernando Eye Institute

Brooksville, Florida 34613

Principal Investigator: Leonard Cacioppo, MD

Phone: 352-596-4030

from

Brooksville, FL

Family Eye Care Center

Campbell, California 95008

Principal Investigator: Larry Wan, OD

Phone: 408-866-2020

from

Campbell, CA

Arizona Eye Center

Chandler, Arizona

Principal Investigator: Michael Depenbusch, MD

Phone: 480-999-5458

from

Chandler, AZ

Chattanooga Eye Institute

Chattanooga, Tennessee 37411

Principal Investigator: Charles Kirby, MD

Phone: 423-892-3937

from

Chattanooga, TN

Scott & Christie and Associates, PC

Cranberry Township, Pennsylvania 16066

Principal Investigator: Daniel Zimmer, MD

Phone: 724-772-5420

from

Cranberry Township, PA

Hoopes Vision

Draper, Utah 84020

Principal Investigator: Majid Moshirfar, MD

Phone: 801-568-0200

from

Draper, UT

Cincinnati Eye Institute

Edgewood, Kentucky 41017

Principal Investigator: Brad Genereux, OD

Phone: 859-331-9000

from

Edgewood, KY

Cataract & Glaucoma Center

El Paso, Texas 79902

Principal Investigator: Louis Alpern, MD

Phone: 915-545-2333

from

El Paso, TX

Drs Fine Hoffman & Sims, LLC

Eugene, Oregon 97401

Principal Investigator: Annette Sims, MD

Phone: 541-687-2110

from

Eugene, OR

Orange County Ophthalmology

Garden Grove, California 92843

Principal Investigator: James Boyce, MD

Phone: 714-534-8373

from

Garden Grove, CA

Lugene Eye Institute

Glendale, California 91205

Principal Investigator: Sherif M El-Harazi, MD

Phone: 818-246-2560

from

Glendale, CA

Cornerstone Eye Care

High Point, North Carolina 27262

Principal Investigator: Robert DaVanzo, MD

Phone: 336-802-2255

from

High Point, NC

Chicago Cornea Consultants, LTD

Hoffman Estates, Illinois

Principal Investigator: Parag Majmudar, MD

Phone: 847-748-3553

from

Hoffman Estates, IL

Houston Eye Associates

Houston, Texas 77025

Principal Investigator: Richard J Ou

Phone: 832-553-7140

from

Houston, TX

Whitsett Vision Group

Houston, Texas 77055

Principal Investigator: Jeffrey Whitsett, MD

Phone: 713-365-9099

from

Houston, TX

Advanced Laser Vision & Surgical Institute, Intouch Clinical Research Center

Houston, Texas 77034

Principal Investigator: Nancy Stephens, OD

Phone: 281-338-0425

from

Houston, TX

The Ocular Surface Institute (TOSI), University of Houston

Houston, Texas 77204

Principal Investigator: Daniel Powell, OD, PhD

Phone: 713-743-2736

from

Houston, TX

Price Vision Group

Indianapolis, Indiana 46260

Principal Investigator: Kathleen Kelley, OD

Phone: 317-814-2996

from

Indianapolis, IN

The Gavin Herbert Eye Institute

Irvine, California 92697

Principal Investigator: Marjan Farid, MD

Phone: 714-456-7741

from

Irvine, CA

NEA Baptist Clinic

Jonesboro, Arkansas 72401

Principal Investigator: Thomas Nix

Phone: 870-934-5210

from

Jonesboro, AR

Tauber Eye Center

Kansas City, Missouri 64111

Principal Investigator: Joseph Tauber, MD

Phone: 816-531-9100

from

Kansas City, MO

Eye Care Specialists

Kingston, Pennsylvania 18704

Principal Investigator: Harvey J Reiser, MD

Phone: 570-714-5910

from

Kingston, PA

Brazosport Eye Institute

Lake Jackson, Texas 77566

Principal Investigator: Jonathan P. Grady, MD

Phone: 979-297-2961

from

Lake Jackson, TX

Central Florida Eye Associates

Lakeland, Florida 33805

Principal Investigator: Jay Mulaney, MD

Phone: 863-686-1010

from

Lakeland, FL

Shettle Eye Research

Largo, Florida

Principal Investigator: Philip L Shettle, DO

Phone: 727-674-2500

from

Largo, FL

Abrams Eye Institute

Las Vegas, Nevada 89148

Principal Investigator: Jack Abrams, MD

Phone: 702-515-9648

from

Las Vegas, NV

Koffler Vision Group

Lexington, Kentucky 40509

Principal Investigator: Bruce Koffler, MD

Phone: 859-263-4631

from

Lexington, KY

Macy Eye Center

Los Angeles, California

Principal Investigator: Jonathan Macy, MD

Phone: 310-657-2777

from

Los Angeles, CA

Advanced Vision Care

Los Angeles, California 90067

Principal Investigator: Nicole Fram, MD

Phone: 310-229-1220

from

Los Angeles, CA

Taustine Eye Center

Louisville, Kentucky 40217

Principal Investigator: Gregory Sulkowski, MD

Phone: 502-458-9004

from

Louisville, KY

The Eye Care Institute

Louisville, Kentucky 40206

Principal Investigator: John Meyer, MD

Phone: 502-589-1500

from

Louisville, KY

Total Eye Care, PA

Memphis, Tennessee

Principal Investigator: David Evans, OD

Phone: 901-761-4620

from

Memphis, TN

North Valley Eye Medical Group, Inc.

Mission Hills, California

Principal Investigator: Steven Rauchman, MD

Phone: 818-365-0606

from

Mission Hills, CA

Regional Eye Associates

Morgantown, West Virginia 26505

Principal Investigator: Heath Lemley, MD

Phone: 304-598-3301

from

Morgantown, WV

Eye Care Centers Management/Clayton Eye Center

Morrow, Georgia 30260

Principal Investigator: Harvey DuBiner, MD

Phone: 770-968-8888

from

Morrow, GA

Toyos Clinic

Nashville, Tennessee 37203

Principal Investigator: Melissa Toyos, MD

Phone: 615-327-4015

from

Nashville, TN

John-Kenyon American Eye Institute

New Albany, Indiana 47150

Principal Investigator: Steve Wilson, OD

Phone: 812-948-0616

from

New Albany, IN

Raymond Fong, MDPC

New York, New York 10013

Principal Investigator: Raymond Fong, MD

Phone: 212-274-1900

from

New York, NY

Eye Research Foundation

Newport Beach, California

Principal Investigator: David Wirta, MD

Phone: 949-650-1863

from

Newport Beach, CA

Virginia Eye Consultants

Norfolk, Virginia 23502

Principal Investigator: John Sheppard, MD

Phone: 757-961-2948

from

Norfolk, VA

International Eye Associates PA

Ormond Beach, Florida 32174

Principal Investigator: Mark Rubin, MD

from

Ormond Beach, FL

Arch Health Partners

Poway, California 92064

Principal Investigator: Jeffrey Lozier, MD

Phone: 858-613-2965

from

Poway, CA

Martel Eye Medical Group

Rancho Cordova, California 95670

Principal Investigator: Joseph R Martel, MD

Phone: 916-631-7860

from

Rancho Cordova, CA

Shasta Eye Medical Group, Inc.

Redding, California

Principal Investigator: Bruce E Silverstein, MD

Phone: 530-223-2500

from

Redding, CA

Ophthalmic Consultants of Long Island

Rockville Centre, New York 11570

Principal Investigator: Henry Perry, MD

Phone: 516-705-7140

from

Rockville Centre, NY

Tekwani Vision Center

9911 Kennerly Road
Saint Louis, Missouri 63128

from

Saint Louis, MO

Kozlovsky Delay & Winter Eye Consultants, LLC

San Antonio, Texas 78230

Principal Investigator: John Kozlovsky, MD

Phone: 210-541-0123

from

San Antonio, TX

West Coast Eye Care Associates

San Diego, California

Principal Investigator: Barry Katzman, MD

Phone: 619-697-4600

from

San Diego, CA

Spokane Eye Clinical Research

Spokane, Washington 99204

Principal Investigator: Randall Jacobson, MD

Phone: 509-623-9768

from

Spokane, WA

Perez Eye Center/International Research Center

Tampa, Florida 33603

Principal Investigator: Bernard Perez, MD

Phone: 813-875-6588

from

Tampa, FL

Wolstan & Goldberg Eye Associates

Torrance, California 90505

Principal Investigator: Damien Goldberg, MD

Phone: 310-602-5640

from

Torrance, CA

Comprehensive Eye Care, Ltd/Vision Research Institute, LLC

Washington, Missouri 63090

Principal Investigator: Michael Korenfeld, MD

Phone: 636-390-3999

from

Washington, MO

Comprehensive Eye Care of Central Ohio

Westerville, Ohio 43082

Principal Investigator: Kenneth Beckman, MD

Phone: 614-890-5692

from

Westerville, OH

Michael K Tran, M.D., Inc.

Westminster, California 92683

Principal Investigator: Michael Tran, MD

Phone: 714-839-2077

from

Westminster, CA

James D. Branch, MD

Winston-Salem, North Carolina 27101

Principal Investigator: James D Branch, MD

Phone: 336-723-0748

from

Winston-Salem, NC

Safety and Efficacy of KPI-121 Compared to Placebo in Subjects With Dry Eye Disease

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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

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