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).

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

Sall Research Medical Center, Inc.

Artesia, California 90701

Principal Investigator: Kenneth Sall, MD

Phone: 562-804-1974

from

Artesia, CA

Dixon Eye Care

Albany, Georgia 31701

Principal Investigator: El-Roy Dixon, MD

Phone: 229-439-7700

from

Albany, GA

Chu Vision Institute

Bloomington, Minnesota 55420

Principal Investigator: Y. Ralph Chu, MD

Phone: 952-835-1235

from

Bloomington, MN

Florida Eye Microsurgical Institute

Boynton Beach, Florida

Principal Investigator: Barry Schechter, MD

Phone: 561-737-5500

from

Boynton Beach, FL

Hill Country Eye Center

Cedar Park, Texas 78613

Principal Investigator: Vincent Restivo, Jr., MD

Phone: 512-528-1144

from

Cedar Park, TX

Mundorf Eye Center

Charlotte, North Carolina

Principal Investigator: Thomas Mundorf, MD

Phone: 704-334-3222

from

Charlotte, NC

Lifelong Vision Foundation at Pepose Vision Institute

Chesterfield, Missouri 63017

Principal Investigator: Mujtaba Qazi, MD

Phone: 636-534-5126

from

Chesterfield, MO

Abrams Eye Center

Cleveland, Ohio 44115

Principal Investigator: Marc Abrams, MD

Phone: 216-937-2020

from

Cleveland, OH

Opthalamic Surgeons & Consultants of Ohio

Columbus, Ohio 43215

Principal Investigator: Alice Epitropoulos, MD

Phone: 614-221-7464

from

Columbus, OH

Scott & Christie and Associates, PC

Cranberry Township, Pennsylvania 16066

Principal Investigator: Daniel Zimmer, MD

Phone: 724-772-5420

from

Cranberry Township, PA

Firozvi Research, LLC / North Carolina Eye, Ear, Nose & Throat

Durham, North Carolina 27704

Principal Investigator: Asra Firozvi, MD

Phone: 919-595-2039

from

Durham, NC

Bergstrom Eye Research

Fargo, North Dakota 58103

Principal Investigator: Lance Bergstrom, MD

Phone: 701-478-0061

from

Fargo, ND

Eye Center of Northern Colorado

Fort Collins, Colorado 80525

Principal Investigator: Benjamin Marske, OD

Phone: 970-221-2222

from

Fort Collins, CO

Eye Associates of Fort Myers

Fort Myers, Florida 33901

Principal Investigator: Stephen E Smith, MD

Phone: 239-939-0413

from

Fort Myers, FL

Orange County Ophthalmology Medical Group

12665 Garden Grove Boulevard
Garden Grove, California 92843

from

Garden Grove, CA

Eye Center of Southern CT, P.C.

Hamden, Connecticut 06518

Principal Investigator: Mark Milner, MD

Phone: 203-248-6365

from

Hamden, CT

Houston Eye Associates

Houston, Texas 77025

Principal Investigator: John Goosey, MD

Phone: 832-280-3635

from

Houston, TX

Midwest Cornea Associates, LLC

Indianapolis, Indiana 46290

Principal Investigator: Clark Springs, MD

Phone: 317-805-4527

from

Indianapolis, IN

United Medical Research Institute

Inglewood, California 90301

Principal Investigator: James H Peace, MD

Phone: 310-671-7172

from

Inglewood, CA

Jacksoneye, S. C.

Lake Villa, Illinois 60046

Principal Investigator: Mitchell A Jackson, MD

Phone: 847-356-0700

from

Lake Villa, IL

Conestoga Eye

Lancaster, Pennsylvania 17601

Principal Investigator: David Silbert, MD, FAAP

Phone: 717-541-9700

from

Lancaster, PA

Shettle Eye Research

Largo, Florida

Principal Investigator: Phillip Shettle, DO

Phone: 727-674-2500

from

Largo, FL

Wellish Vision Institute

Las Vegas, Nevada 89119

Principal Investigator: Kent Wellish, MD

Phone: 702-932-4270

from

Las Vegas, NV

Tanner Clinic

Layton, Utah 84041

Principal Investigator: Trent Richards, MD

Phone: 801-773-4840

from

Layton, UT

The Eye Clinic of Texas, Affiliate of Houston Eye Associates

League City, Texas 77573

Principal Investigator: Da-Thuy Van, DO

Phone: 281-332-3937

from

League City, TX

Lake Travis Eye and Laser Center

Leander, Texas 78641

Principal Investigator: Kyle Rhodes, MD

Phone: 512-528-5795

from

Leander, TX

Eyecare Arkansas, P.A.

Little Rock, Arkansas 72205

Principal Investigator: Robert L Berry, MD

Phone: 501-225-4488

from

Little Rock, AR

Little Rock Eye Clinic, LLP

Little Rock, Arkansas 72205

Principal Investigator: Laurie Barber, MD

Phone: 501-224-5658

from

Little Rock, AR

Corneal Consultants of Colorado, P.C

Littleton, Colorado

Principal Investigator: S. Lance Forstot, MD

Phone: 303-730-0404

from

Littleton, CO

Apex Eye

Mason, Ohio 45040

Principal Investigator: Edward Meier, MD

Phone: 513-770-4020

from

Mason, OH

See Clearly Vision

McLean, Virginia 22102

Principal Investigator: Khoa Hoang, MD

Phone: 703-287-4125

from

McLean, VA

Total Eye Care, PA

Memphis, Tennessee

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

Montebello Medical Center, Inc.

Montebello, California 90640

Principal Investigator: Reginald Sampson, MD

Phone: 323-728-7998

from

Montebello, CA

LoBue Laser and Eye Medical Center

40700 California Oaks Road
Murrieta, California 92562

from

Murrieta, CA

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: Elizabeth Yeu, MD

Phone: 757-622-2200

from

Norfolk, VA

Pendleton Eye Center

Oceanside, California 92056

Principal Investigator: Robert B. Pendleton, MD, PhD

Phone: 760-758-2008

from

Oceanside, CA

Stiles Eyecare Excellence and Glaucoma Institute

Overland Park, Kansas 66213

Principal Investigator: Michael Stiles, MD

Phone: 913-681-1601

from

Overland Park, KS

Atlantic Eye Center

Palm Coast, Florida 32137

Principal Investigator: Alexandra Kostick, MD

Phone: 386-446-9590

from

Palm Coast, FL

The Eye Center of North Florida

Panama City, Florida 32405

Principal Investigator: Bret Fisher, MD

Phone: 850-784-3937

from

Panama City, FL

Matossian Eye Associates

Pennington, New Jersey 08534

Principal Investigator: Cynthia Matossian, MD, FACS

Phone: 609-323-1560

from

Pennington, NJ

North Bay Eye Associates

Petaluma, California 94954

Principal Investigator: Jason Bacharach, MD

from

Petaluma, CA

Cornea & Cataract Consultants of Arizona

Phoenix, Arizona 85032

Principal Investigator: Robert H Gross, MD

Phone: 602-258-4342

from

Phoenix, AZ

UPMC Eye Center

Pittsburgh, Pennsylvania 15213

Principal Investigator: Deepinder Dhaliwal, MD

Phone: 412-383-9033

from

Pittsburgh, PA

Eyecare Center

Raleigh, North Carolina 27603

Principal Investigator: Carol Aune, OD

Phone: 919-362-6882

from

Raleigh, NC

Martel Eye Medical Group

Rancho Cordova, California 95670

Principal Investigator: Joseph R Martel, MD

Phone: 916-631-7860

from

Rancho Cordova, CA

Black Hills Regional Eye Institute

Rapid City, South Dakota 57701

Principal Investigator: Terrence Spencer, MD

Phone: 605-719-3153

from

Rapid City, SD

Rochester Ophthalmological Group

Rochester, New York 14618

Principal Investigator: Paul Hartman, MD

Phone: 585-244-6011

from

Rochester, NY

Roseburg Research Associates, LLC

Roseburg, Oregon 97471

Principal Investigator: Jon-Marc Weston, MD

Phone: 541-672-2020

from

Roseburg, OR

Sacramento Eye Consultants

Sacramento, California 95815

Principal Investigator: Patricia Sierra, MD

Phone: 916-649-1515

from

Sacramento, CA

Ophthalmology Consultants Ltd

Saint Louis, Missouri 63141

from

Saint Louis, MO

Ophthalmology Associates

Saint Louis, Missouri 63131

from

Saint Louis, MO

Eye Clinics of South Texas

San Antonio, Texas 78209

Principal Investigator: Jay Rubin, MD

Phone: 210-826-2012

from

San Antonio, TX

R and R Eye Research, LLC

San Antonio, Texas 78229

Principal Investigator: Robert Rice, MD

Phone: 210-424-2584

from

San Antonio, TX

Keystone Research - Medical Center Ophthalmology Associates

San Antonio, Texas 78240

Principal Investigator: Richard Evans, MD

Phone: 210-696-9706

from

San Antonio, TX

Schwartz Laser Eye Center

8416 E. Shea Blvd., Ste C-101
Scottsdale, Arizona 85260

Principal Investigator: Jay Schwartz, DO

Phone: 480-483-3937

from

Scottsdale, AZ

Cornea Consultants of Albany

Slingerlands, New York 12159

Principal Investigator: Robert Schultze, MD

Phone: 518-475-1515

from

Slingerlands, NY

South Shore Eye Center, LLP

Wantagh, New York 11793

Principal Investigator: Jodi Luchs, MD

Phone: 516-785-3900

from

Wantagh, NY

Clinical Eye Research of Boston

Winchester, Massachusetts 01890

Principal Investigator: Jack Greiner, OD, PhD

Phone: 781-729-3008

from

Winchester, MA

Safety and Efficacy of KPI-121 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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