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Completed Phase 3 Interventional Results available

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

ClinicalTrials.gov ID: NCT02813265

Public ClinicalTrials.gov record NCT02813265. 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, 9:48 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
NCT02813265
Recruitment status
Completed
Study type
Interventional
Phase
Phase 3
Lead sponsor
Kala Pharmaceuticals, Inc.
Industry
Enrollment
918 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
Oct 2017 (Actual)
Completion
Oct 2017 (Actual)
Last update posted
Feb 3, 2021

2016 – 2017

United States locations

U.S. sites
60
U.S. states
26
U.S. cities
56
Facility City State ZIP Site status
Cornea and Cataract Consultants of Arizona Phoenix Arizona 85032 —
Schwartz Laser Eye Center Scottsdale Arizona 85260 —
Eyecare Arkansas, P.A. Little Rock Arkansas 72205 —
Little Rock Eye Clinic, LLP Little Rock Arkansas 72205 —
Sall Research Medical Center Artesia California 90701 —
Orange County Ophthalmology Medical Group Garden Grove California 92843 —
United Medical Research Institute Inglewood California 90301 —
North Valley Eye Medical Group Mission Hills California 91345 —
Montebello Medical Center, Inc. Montebello California 90640 —
LoBue Laser and Eye Medical Center Murrieta California 92562 —
Eye Research Foundation Newport Beach California 92663 —
Pendleton Eye Center Oceanside California 92056 —
North Bay Eye Associates, Inc. Petaluma California 94954 —
Martel Eye Medical Group Rancho Cordova California 95670 —
Sacramento Eye Consultants Sacramento California 95815 —
Eye Center of Northern Colorado, PC Fort Collins Colorado 80525 —
Corneal Consultants of Colorado Littleton Colorado 80209 —
The Eye Center of Southern CT, P.C. Hamden Connecticut 06518 —
Florida Eye Microsurgical Institute, Inc. Boynton Beach Florida 33426 —
Eye Associates of Fort Myers Fort Myers Florida 33901 —
Shettle Eye Research, Inc. Largo Florida 33773 —
Atlantic Eye Center Palm Coast Florida 32137 —
The Eye Center of North Florida Panama City Florida 32405 —
Dixon Eye Care Albany Georgia 31701 —
Jacksoneye, S. C. Lake Villa Illinois 60046 —
Midwest Cornea Associates, LLC Indianapolis Indiana 46290 —
Stiles EyeCare Excellence and Glaucoma Institute Overland Park Kansas 66213 —
Clinical Eye Research of Boston Winchester Massachusetts 01890 —
Chu Vision Institute Bloomington Minnesota 55420 —
Lifelong Vision Foundation at Pepose Vision Institute Chesterfield Missouri 63017 —
Ophthalmology Associates St Louis Missouri 63131 —
Ophthalmology Consultants, Ltd. St Louis Missouri 63131 —
Wellish Vision Institute Las Vegas Nevada 89119 —
Matossian Eye Associates Pennington New Jersey 08534 —
Rochester Ophthalmological Group, PC Rochester New York 14618 —
Cornea Consultants of Albany Slingerlands New York 12159 —
South Shore Eye Center, LLP Wantagh New York 11793 —
Mundorf Eye Center Charlotte North Carolina 28204 —
Firozvi Research, LLC / North Carolina Eye, Ear, Nose & Throat Durham North Carolina 27704 —
Eyecare Center Raleigh North Carolina 27603 —
Bergstrom Eye Research Fargo North Dakota 58103 —
Abrams Eye Center Cleveland Ohio 44115 —
Opthalamic Surgeons & Consultants of Ohio Columbus Ohio 43215 —
Apex Eye Mason Ohio 45040 —
Roseburg Research Associates, LLC Roseburg Oregon 97471 —
Scott & Christie and Associates, PC Cranberry Township Pennsylvania 16066 —
Conestoga Eye Lancaster Pennsylvania 17601 —
UPMC Eye Center Pittsburgh Pennsylvania 15213 —
Black Hills Regional Eye Institute Rapid City South Dakota 57701 —
Total Eye Care, PA Memphis Tennessee 38119 —
Hill Country Eye Center Cedar Park Texas 78613 —
Houston Eye Associates Houston Texas 77025 —
The Eye Clinic of Texas, Affiliate of Houston Eye Associates League City Texas 77573 —
Lake Travis Eye and Laser Center Leander Texas 78641 —
Eye Clinics of South Texas San Antonio Texas 78209 —
R and R Eye Research, LLC San Antonio Texas 78229 —
Keystone Research - Medical Center Ophthalmology Associates San Antonio Texas 78240 —
Tanner Clinic Layton Utah 84041 —
See Clearly Vision McLean Virginia 22102 —
Virginia Eye Consultants Norfolk Virginia 23502 —

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 NCT02813265, 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 Feb 3, 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 NCT02813265 live on ClinicalTrials.gov.

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