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

Last updated: January 19, 2021
Sponsor: Kala Pharmaceuticals, Inc.
Overall Status: Completed

Phase

3

Condition

Eyelid Inflammation

Dry Eyes

Sjogren's Syndrome

Treatment

N/A

Clinical Study ID

NCT02813265
KPI-121-C-006
  • Ages > 18
  • All Genders

Study Summary

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).

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Have a documented clinical diagnosis of dry eye disease in both eyes

Exclusion

Exclusion Criteria:

  • Known hypersensitivity or contraindication to the investigational product(s) orcomponents
  • History of glaucoma, Intraocular Pressure (IOP) >21 mmHg at the screening orrandomization visits, or being treated for glaucoma in either eye.
  • Diagnosis of: ongoing ocular infection; severe/serious ocular condition that injudgment of Investigator could confound study assessments or limit compliance; or havebeen exposed to an investigational drug within 30 days prior to screening.
  • In the opinion of the Investigator or study coordinator, be unwilling or unable tocomply with study protocol or unable to successfully instill eye drops.

Study Design

Total Participants: 918
Study Start date:
June 01, 2016
Estimated Completion Date:
October 31, 2017

Study Description

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.

Connect with a study center

  • Cornea and Cataract Consultants of Arizona

    Phoenix, Arizona 85032
    United States

    Site Not Available

  • Schwartz Laser Eye Center

    Scottsdale, Arizona 85260
    United States

    Site Not Available

  • Eyecare Arkansas, P.A.

    Little Rock, Arkansas 72205
    United States

    Site Not Available

  • Little Rock Eye Clinic, LLP

    Little Rock, Arkansas 72205
    United States

    Site Not Available

  • Sall Research Medical Center

    Artesia, California 90701
    United States

    Site Not Available

  • Orange County Ophthalmology Medical Group

    Garden Grove, California 92843
    United States

    Site Not Available

  • United Medical Research Institute

    Inglewood, California 90301
    United States

    Site Not Available

  • North Valley Eye Medical Group

    Mission Hills, California 91345
    United States

    Site Not Available

  • Montebello Medical Center, Inc.

    Montebello, California 90640
    United States

    Site Not Available

  • LoBue Laser and Eye Medical Center

    Murrieta, California 92562
    United States

    Site Not Available

  • Eye Research Foundation

    Newport Beach, California 92663
    United States

    Site Not Available

  • Pendleton Eye Center

    Oceanside, California 92056
    United States

    Site Not Available

  • North Bay Eye Associates, Inc.

    Petaluma, California 94954
    United States

    Site Not Available

  • Martel Eye Medical Group

    Rancho Cordova, California 95670
    United States

    Site Not Available

  • Sacramento Eye Consultants

    Sacramento, California 95815
    United States

    Site Not Available

  • Eye Center of Northern Colorado, PC

    Fort Collins, Colorado 80525
    United States

    Site Not Available

  • Corneal Consultants of Colorado

    Littleton, Colorado 80209
    United States

    Site Not Available

  • The Eye Center of Southern CT, P.C.

    Hamden, Connecticut 06518
    United States

    Site Not Available

  • Florida Eye Microsurgical Institute, Inc.

    Boynton Beach, Florida 33426
    United States

    Site Not Available

  • Eye Associates of Fort Myers

    Fort Myers, Florida 33901
    United States

    Site Not Available

  • Shettle Eye Research, Inc.

    Largo, Florida 33773
    United States

    Site Not Available

  • Atlantic Eye Center

    Palm Coast, Florida 32137
    United States

    Site Not Available

  • The Eye Center of North Florida

    Panama City, Florida 32405
    United States

    Site Not Available

  • Dixon Eye Care

    Albany, Georgia 31701
    United States

    Site Not Available

  • Jacksoneye, S. C.

    Lake Villa, Illinois 60046
    United States

    Site Not Available

  • Midwest Cornea Associates, LLC

    Indianapolis, Indiana 46290
    United States

    Site Not Available

  • Stiles EyeCare Excellence and Glaucoma Institute

    Overland Park, Kansas 66213
    United States

    Site Not Available

  • Clinical Eye Research of Boston

    Winchester, Massachusetts 01890
    United States

    Site Not Available

  • Chu Vision Institute

    Bloomington, Minnesota 55420
    United States

    Site Not Available

  • Lifelong Vision Foundation at Pepose Vision Institute

    Chesterfield, Missouri 63017
    United States

    Site Not Available

  • Ophthalmology Associates

    Saint Louis, Missouri 63131
    United States

    Site Not Available

  • Ophthalmology Consultants, Ltd.

    Saint Louis, Missouri 63131
    United States

    Site Not Available

  • Ophthalmology Consultants, Ltd.

    St. Louis, Missouri 63131
    United States

    Site Not Available

  • Wellish Vision Institute

    Las Vegas, Nevada 89119
    United States

    Site Not Available

  • Eyesight Ophthalmic Services, PA

    Somersworth, New Hampshire 03878
    United States

    Site Not Available

  • Matossian Eye Associates

    Pennington, New Jersey 08534
    United States

    Site Not Available

  • Rochester Ophthalmological Group, PC

    Rochester, New York 14618
    United States

    Site Not Available

  • Cornea Consultants of Albany

    Slingerlands, New York 12159
    United States

    Site Not Available

  • South Shore Eye Center, LLP

    Wantagh, New York 11793
    United States

    Site Not Available

  • Mundorf Eye Center

    Charlotte, North Carolina 28204
    United States

    Site Not Available

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

    Durham, North Carolina 27704
    United States

    Site Not Available

  • Eyecare Center

    Raleigh, North Carolina 27603
    United States

    Site Not Available

  • Bergstrom Eye Research

    Fargo, North Dakota 58103
    United States

    Site Not Available

  • Abrams Eye Center

    Cleveland, Ohio 44115
    United States

    Site Not Available

  • Opthalamic Surgeons & Consultants of Ohio

    Columbus, Ohio 43215
    United States

    Site Not Available

  • Apex Eye

    Mason, Ohio 45040
    United States

    Site Not Available

  • Roseburg Research Associates, LLC

    Roseburg, Oregon 97471
    United States

    Site Not Available

  • Scott & Christie and Associates, PC

    Cranberry Township, Pennsylvania 16066
    United States

    Site Not Available

  • Conestoga Eye

    Lancaster, Pennsylvania 17601
    United States

    Site Not Available

  • Philadelphia Eye Associates

    Philadelphia, Pennsylvania 19148
    United States

    Site Not Available

  • UPMC Eye Center

    Pittsburgh, Pennsylvania 15213
    United States

    Site Not Available

  • Carolina Eyecare Physicians, LLC

    Mt. Pleasant, South Carolina 29464
    United States

    Site Not Available

  • Black Hills Regional Eye Institute

    Rapid City, South Dakota 57701
    United States

    Site Not Available

  • Vance Thompson Vision

    Sioux Falls, South Dakota 57108
    United States

    Site Not Available

  • Total Eye Care, PA

    Memphis, Tennessee 38119
    United States

    Site Not Available

  • Total Eye Care, PA

    Mephis, Tennessee 38119
    United States

    Site Not Available

  • Hill Country Eye Center

    Cedar Park, Texas 78613
    United States

    Site Not Available

  • Houston Eye Associates

    Houston, Texas 77025
    United States

    Site Not Available

  • The Eye Clinic of Texas, Affiliate of Houston Eye Associates

    League City, Texas 77573
    United States

    Site Not Available

  • Lake Travis Eye and Laser Center

    Leander, Texas 78641
    United States

    Site Not Available

  • Eye Clinics of South Texas

    San Antonio, Texas 78209
    United States

    Site Not Available

  • Keystone Research - Medical Center Ophthalmology Associates

    San Antonio, Texas 78240
    United States

    Site Not Available

  • R and R Eye Research, LLC

    San Antonio, Texas 78229
    United States

    Site Not Available

  • Tanner Clinic

    Layton, Utah 84041
    United States

    Site Not Available

  • See Clearly Vision

    McLean, Virginia 22102
    United States

    Site Not Available

  • Virginia Eye Consultants

    Norfolk, Virginia 23502
    United States

    Site Not Available

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