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Completed Phase 3 Interventional Results available

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

ClinicalTrials.gov ID: NCT02819284

Public ClinicalTrials.gov record NCT02819284. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Oct 21, 2026, 9:10 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

A Phase 3, Double-Masked, Randomized, Controlled Study of KPI-121 0.25% Ophthalmic Suspension Compared to Vehicle in Subjects With Dry Eye Disease

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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).

Study identification

NCT ID
NCT02819284
Recruitment status
Completed
Study type
Interventional
Phase
Phase 3
Lead sponsor
Kala Pharmaceuticals, Inc.
Industry
Enrollment
909 participants

Conditions and interventions

Eligibility (public fields only)

Age range
18 Years and older
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Jun 2016 (Actual)
Primary completion
Sep 2017 (Actual)
Completion
Sep 2017 (Actual)
Last update posted
Jan 5, 2021

2016 – 2017

United States locations

U.S. sites
62
U.S. states
24
U.S. cities
57
Facility City State ZIP Site status
UAB School of Optometry Birmingham Alabama 35294-0010 —
Arizona Eye Center Chandler Arizona 85225 —
NEA Baptist Clinic Jonesboro Arkansas 72401 —
Sall Research Medical Center Artesia California 90701 —
Milton M. Hom, OD, FAAO Azusa California 91702 —
Family Eye Care Center Campbell California 95008 —
Orange County Ophthalmology Garden Grove California 92843 —
Lugene Eye Institute Glendale California 91204 —
The Gavin Herbert Eye Institute Irvine California 92697-4375 —
Macy Eye Center Los Angeles California 90048 —
Advanced Vision Care Los Angeles California 90067 —
North Valley Eye Medical Group Mission Hills California — —
Eye Research Foundation Newport Beach California 92663 —
Arch Health Partners Poway California 92064 —
Martel Eye Medical Group Rancho Cordova California 95670 —
Shasta Eye Medical Group, Inc Redding California 96002 —
West Coast Eye Care Associates San Diego California 92115 —
Wolstan & Goldberg Eye Associates Torrance California 90505 —
Michael K Tran, M.D., Inc. Westminster California 92683 —
Hernando Eye Institute Brooksville Florida 34613 —
Central Florida Eye Associates Lakeland Florida 33805 —
Shettle Eye Research, Inc Largo Florida 33773 —
International Eye Associates PA Ormond Beach Florida 32174 —
Perez Eye Center/International Research Center Tampa Florida 33603 —
Eye Care Centers Management, Inc. (Clayton Eye Center) Morrow Georgia 30260 —
Chicago Cornea Consultants, Ltd. Hoffman Estates Illinois 60169 —
Price Vision Group Indianapolis Indiana 46260 —
John-Kenyon American Eye Institute New Albany Indiana 47150 —
Cincinnati Eye Institute Edgewood Kentucky 41017 —
Koffler Vision Group Lexington Kentucky 40509 —
The Eye Care Institute Louisville Kentucky 40206 —
Taustine Eye Center Louisville Kentucky 40217 —
Ophthalmic Consultants of Boston Boston Massachusetts 02114 —
Minnesota Eye Consultants, PA Bloomington Minnesota 55431 —
Tauber Eye Center Kansas City Missouri 64111 —
Tekwani Vision Center St Louis Missouri 63128 —
Comprehensive Eye Care, Ltd. / Vision Research Institute, LLC Washington Missouri 63090 —
Abrams Eye Institute Las Vegas Nevada 89148 —
Raymond Fong, MDPC New York New York 10013 —
Ophthalmic Consultants of Long Island Rockville Centre New York 11570 —
Cornerstone Eye Care High Point North Carolina 27262 —
James D Branch MD Winston-Salem North Carolina 27101 —
Comprehensive Eye Care of Central Ohio Westerville Ohio 43082 —
Drs. Fine, Hoffman & Sims, LLC Eugene Oregon 97401 —
Scott & Christie and Associates, PC Cranberry Township Pennsylvania 16066 —
Eye Care Specialists Kingston Pennsylvania 18704 —
Bucci Laser Vision Institute Wilkes-Barre Pennsylvania 18702 —
Chattanooga Eye Institute, P.C. Chattanooga Tennessee 37411 —
Total Eye Care, PA Memphis Tennessee 38119 —
Toyos Clinic Nashville Tennessee 37215 —
Texan Eye, PA / Keystone Research, Ltd Austin Texas 78731 —
The Cataract and Glaucoma Center El Paso Texas 79902 —
Houston Eye Associates Houston Texas 77024 —
Advanced Laser Vision & Surgical Institute, Intouch Clinical Research Center Houston Texas 77034 —
Whitsett Vision Group Houston Texas 77055 —
The Ocular Surface Institute (TOSI), University of Houston Houston Texas 77204 —
Brazosport Eye Institute Lake Jackson Texas 77566 —
Kozlovsky Delay & Winter Eye Consultants, LLC San Antonio Texas 78230 —
Hoopes Vision Draper Utah 84020 —
Virginia Eye Consultants Norfolk Virginia 23502 —
Spokane Eye Clinical Research Spokane Washington 99204 —
Regional Eye Associates Morgantown West Virginia 26505 —

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT02819284, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Jan 5, 2021 · Synced Oct 21, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT02819284 live on ClinicalTrials.gov.

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