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NCT04393441 · ClinicalTrials.gov registry record · Phase 3
Efficacy and Safety of a New Artificial Tear Formulation Compared With Systane Ultra Multidose in Participants With Dry Eye Disease
A Phase 3 study of Dry Eye Disease (DED), sponsored by Allergan.
- Completed
- Registry status
- Phase 3
- Development phase
- 400
- Enrollment target
- 20
- Study locations
NCT04393441: Completed Phase 3 study of Dry Eye Disease (DED), sponsored by Allergan.
NCT04393441 is a Phase 3 study of Dry Eye Disease (DED) that has completed, run by Allergan. The registered enrollment target is 400 participants, above the 358-participant average among 3 other Dry Eye Disease (DED) trials with a reported enrollment target (12% higher). The trial reports 20 study locations across 8 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04393441, a Phase 3 study of Dry Eye Disease (DED), has completed, sponsored by Allergan.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 400 participants
- Enrollment target
- 20
- Study locations
Study Summary
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).
Primary Outcome
The total staining score is the sum of corneal and conjunctival staining score using Modified NEI grading scale. The cornea is divided into 5 zones and the nasal and temporal conjunctiva is divided into 6 zones. The combined total staining score is based on the sum of the five zones on the cornea and six zones on the conjunctiva. Each zone is graded on a 0 to 5 scale (0=no staining; 1=trace; 2=mild; 3=moderate; 4=severe; 5=very severe), for a total score ranging from 0 to 55. The higher the scor
Conditions Studied
Interventions
- DRUG 011516X (New Artificial Tear Formulation)
- DRUG Systane Ultra Multidose
- DRUG REFRESH PLUS®
Study Locations (20)
California
- Milton M. Hom, OD, FAAO - Azusa
- Global Research Management - Glendale
- Eye Research Foundation - Newport Beach
- North Bay Eye Associates, Inc. - Petaluma
- Eric M. White OD Inc - San Diego
- Wolstan & Goldberg Eye Associates - Torrance
Florida
- Nature Coast Clinical Research - Crystal River
- Bowden Eye & Associates - Jacksonville
- South Florida Research Center, Inc. - Miami
- Vista Health Research, LLC - Miami
- Clinical Research Center of Florida - Pompano Beach
Georgia
- Georgia Eye Partners - Atlanta
- Clayton Eye Clinical Research, LLC - Morrow
Kansas
- Alliance for Multispecialty Research, LLC - Newton
- Kannarr Eye Care, LLC - Pittsburg
Missouri
- Moyes Eye Center - Kansas City
- Ophthalmology Associates - Saint Charles
Kentucky
- Senior Health Services - Louisville
Nevada
- Eye Care Associates of Nevada - Sparks
New York
- Rochester Ophthalmological Group, PC - Rochester
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 400 participants |
| Start Date | 2020-06-29 |
| Est. Completion | 2021-06-15 |
| Phase | Phase 3 |
What the finished NCT04393441 record still lists
NCT04393441 is an interventional study that assigns participants to a tested intervention. The registered 400 participants enrollment target is mid-sized for trials with a published cap, above the 358-participant average among 3 other Dry Eye Disease (DED) trials with a reported enrollment target (12% higher).
The record links to 1 condition, with Dry Eye Disease (DED) appearing as the primary indexed condition, and to 3 interventions - of which 011516X (New Artificial Tear Formulation) is the first listed.
NCT04393441 names 20 study sites across 8 states, led by California, Florida, Georgia.
Frequently Asked Questions
What is clinical trial NCT04393441 about?
NCT04393441 is a clinical study titled "Efficacy and Safety of a New Artificial Tear Formulation Compared With Systane Ultra Multidose in Participants With Dry Eye Disease". 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).
What is the current status of trial NCT04393441?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 400 participants. The study started on 2020-06-29. Estimated completion is 2021-06-15.
What conditions does trial NCT04393441 study?
This clinical trial studies the following conditions: Dry Eye Disease (DED).
What interventions are being tested in trial NCT04393441?
The interventions under investigation include: 011516X (New Artificial Tear Formulation) (DRUG), Systane Ultra Multidose (DRUG), REFRESH PLUS® (DRUG).
Who is sponsoring clinical trial NCT04393441?
This trial is sponsored by Allergan, which has 314 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04393441 being conducted?
This trial has 20 study locations across California, Florida, Georgia, Kansas, Kentucky. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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