Efficacy and Safety of a New Artificial Tear Formulation Compared With Systane Ultra Multidose in Participants With Dry Eye Disease
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.
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
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The purpose of this study is 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 (DED).
Study identification
- NCT ID
- NCT04393441
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 400 participants
Conditions and interventions
Conditions
Interventions
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 29, 2020 (Actual)
- Primary completion
- Jun 15, 2021 (Actual)
- Completion
- Jun 15, 2021 (Actual)
- Last update posted
- Jun 26, 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 26, 2024 · Synced Oct 22, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT04393441 live on ClinicalTrials.gov.