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Completed Phase 3 Interventional Results available

Safety and Efficacy of KPI-121 in Subjects With DED

ClinicalTrials.gov ID: NCT03616899

Public ClinicalTrials.gov record NCT03616899. 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 24, 2026, 6:12 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 (STRIDE 3)

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
NCT03616899
Recruitment status
Completed
Study type
Interventional
Phase
Phase 3
Lead sponsor
Kala Pharmaceuticals, Inc.
Industry
Enrollment
901 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
Jul 10, 2018 (Actual)
Primary completion
Feb 5, 2020 (Actual)
Completion
Feb 5, 2020 (Actual)
Last update posted
Apr 2, 2021

2018 – 2020

United States locations

U.S. sites
81
U.S. states
21
U.S. cities
67
Facility City State ZIP Site status
Investigator #133 Birmingham Alabama 35294 —
Investigator #278 Dothan Alabama 36301 —
Investigator #146 Chandler Arizona 85224 —
Investigator #148 Phoenix Arizona 85032 —
Investigator #280 Prescott Arizona 86301 —
Investigator #276 Sun City Arizona 85351 —
Investigator #185 Azusa California 91702 —
Investigator #143 Garden Grove California 92843 —
Investigator #147 Glendale California 91204 —
Investigator #272 Hemet California 92545 —
Investigator #155 Inglewood California 90301 —
Investigator #273 Long Beach California 90805 —
Investigator #130 Mission Hills California 91345 —
Investigator #247 Murrieta California 92562 —
Investigator #215 Newport Beach California 92663 —
Site #111 Rancho Cordova California 95670 —
Investigator #271 Santa Ana California 92705 —
Investigator #107 Torrance California 90505 —
Investigator #213 Westminster California 92683 —
Investigator #218 Littleton Colorado 80120 —
Investigator #184 Brooksville Florida 34613 —
Investigator #262 Delray Beach Florida 33484 —
Investigator #279 Fort Myers Florida 33901 —
Investigator #265 Jacksonville Florida 32256 —
Investigator #157 Largo Florida 33773 —
Investigator #189 Tampa Florida 33603 —
Investigator #136 Morrow Georgia 30260 —
Investigator #268 Roswell Georgia 30076 —
Investigator #266 Chicago Illinois 60616 —
Investigator #187 Hoffman Estates Illinois 60169 —
Investigator #151 Lake Villa Illinois 60046 —
Investigator #128 Indianapolis Indiana 46260 —
Investigator #250 Indianapolis Indiana 46290 —
Investigator #125 New Albany Indiana 47150 —
Investigator #274 Lexington Kentucky 40517 —
Investigator #195 Louisville Kentucky 40206 —
Investigator #168 Louisville Kentucky 40220 —
Investigator #219 Winchester Massachusetts 01890 —
Investigator #267 Kansas City Missouri 64133 —
Investigator #123 St Louis Missouri 63128 —
Investigator #106 St Louis Missouri 63131 —
Investigator #126 St Louis Missouri 63131 —
Investigator #131 Washington Missouri 63090 —
Investigator #281 Henderson Nevada 89052 —
Investigator #275 Las Vegas Nevada 89123 —
Investigator #263 Las Vegas Nevada 89145 —
Investigator #138 Las Vegas Nevada 89148 —
Investigator #105 New York New York 10013 —
Investigator #108 Rochester New York 14618 —
Investigator #132 Wantagh New York 11793 —
Investigator #264 Asheville North Carolina 28803 —
Investigator #217 Durham North Carolina 27704 —
Investigator #149 Durham North Carolina 27710 —
Investigator #102 High Point North Carolina 27262 —
Investigator #163 Raleigh North Carolina 27603 —
Investigator #282 Southern Pines North Carolina 28387 —
Investigator #269 Cincinnati Ohio 45242 —
Investigator #142 Cincinnati Ohio 45247 —
Investigator #137 Cleveland Ohio 44115 —
Investigator #171 Mason Ohio 45040 —
Investigator #224 Cranberry Township Pennsylvania 16066 —
Investigator #156 Kingston Pennsylvania 18704 —
Investigator #200 Lancaster Pennsylvania 17601 —
Investigator #277 West Mifflin Pennsylvania 15122 —
Investigator #240 Rapid City South Dakota 57701 —
Investigator #127 Memphis Tennessee 38119 —
Investigator #270 Austin Texas 78681 —
Investigator #188 Austin Texas 78731 —
Investigator #174 Cedar Park Texas 78613 —
Investigator #140 El Paso Texas 79902 —
Investigator #124 Houston Texas 77055 —
Investigator #259 Houston Texas 77204 —
Investigator #175 Lakeway Texas 78734 —
Investigator #182 League City Texas 77573 —
Investigator #191 League City Texas 77573 —
Site #177 San Antonio Texas 78209 —
Investigator #258 San Antonio Texas 78229 —
Investigator #186 San Antonio Texas 78230 —
Investigator #176 San Antonio Texas 78240 —
Investigator #222 Layton Utah 84041 —
Investigator #119 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 NCT03616899, 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 Apr 2, 2021 · Synced Oct 24, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT03616899 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →