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

NCT04393441 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 400

Last updated 2024-06-26

Study results available
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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).

Conditions

  • Dry Eye Disease (DED)

Interventions

DRUG

011516X (New Artificial Tear Formulation)

Topical eye drops

DRUG

Systane Ultra Multidose

Topical eye drops

DRUG

REFRESH PLUS®

Topical eye drops

Sponsors & Collaborators

  • Allergan

    lead INDUSTRY

Principal Investigators

  • Michael Robinson, MD · Allergan

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-06-29
Primary Completion
2021-06-15
Completion
2021-06-15
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04393441 on ClinicalTrials.gov