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Completed Phase 3 Interventional Results available

Efficacy and Safety of a New Artificial Tear Formulation Compared With Systane Ultra Multidose in Participants With Dry Eye Disease

ClinicalTrials.gov ID: NCT04393441

Public ClinicalTrials.gov record NCT04393441. 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 Jul 22, 2026, 5:10 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 Multicenter, Single-masked, Randomized Study to Compare the Efficacy and Safety of a New Artificial Tear Formulation (011516X) With Systane® Ultra Multidose for 90 Days in Participants With Dry Eye Disease

Study identification

NCT ID
NCT04393441
Recruitment status
Completed
Study type
Interventional
Phase
Phase 3
Lead sponsor
Allergan
Industry
Enrollment
400 participants

Conditions and interventions

Interventions

  • 011516X (New Artificial Tear Formulation) Drug
  • Systane Ultra Multidose Drug
  • REFRESH PLUS® Drug

Drug

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 28, 2020
Primary completion
Jun 14, 2021
Completion
Jun 14, 2021
Last update posted
Jun 25, 2024

2020 – 2021

United States locations

U.S. sites
26
U.S. states
13
U.S. cities
25
Facility City State ZIP Site status
Milton M. Hom, OD, FAAO Azusa California 91702
Global Research Management Glendale California 91204
Eye Research Foundation Newport Beach California 92663
North Bay Eye Associates, Inc. Petaluma California 91954
Eric M. White OD Inc San Diego California 92123
Wolstan & Goldberg Eye Associates Torrance California 90505
Nature Coast Clinical Research Crystal River Florida 34429
Bowden Eye & Associates Jacksonville Florida 32256
South Florida Research Center, Inc. Miami Florida 33135
Vista Health Research, LLC Miami Florida 33176
Clinical Research Center of Florida Pompano Beach Florida 33060
Georgia Eye Partners Atlanta Georgia 30342
Clayton Eye Clinical Research, LLC Morrow Georgia 30260
Alliance for Multispecialty Research, LLC Newton Kansas 67114
Kannarr Eye Care, LLC Pittsburg Kansas 66762
Senior Health Services Louisville Kentucky 40220
Moyes Eye Center Kansas City Missouri 64154
Ophthalmology Associates Saint Charles Missouri 63304
Eye Care Associates of Nevada Sparks Nevada 89431
Rochester Ophthalmological Group, PC Rochester New York 14618
Wake Forest Health Network Ophthalmology - Oak Hollow High Point North Carolina 27262
Eye Care Associates of Greater Cincinnati, Inc. dba Apex Eye Cincinnati Ohio 45236
West Bay Eye Associates Warwick Rhode Island 02888
Total Eye Care, PA Memphis Tennessee 38119
Advancing Vision Research Nashville Tennessee 37205
DCT-Shah Research, LLC dba Discovery Clinical Trials Mission Texas 78572

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 NCT04393441, 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 Jun 25, 2024 · Synced Jul 22, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT04393441 live on ClinicalTrials.gov.

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