At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 400 enrolled
Drug / intervention
011516X (New Artificial Tear Formulation) +2 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 3 clinical trial evaluating 011516X (New Artificial Tear Formulation), Systane Ultra Multidose, and 1 other intervention for Dry Eye Disease (DED). Completed, enrolled 400 participants across 26 sites.
Detailed 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).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDry Eye Disease (DED)
CountriesUnited States
Collaborators--
Timeline
Phase 3CompletedFinished
202120222023202420252026
First PostedMay 2020
Enrollment StartJun 2020
Primary CompletionJun 2021
TodayJul 2026
First PostedMay 19, 2020
Enrollment StartJun 29, 2020
Primary CompletionJun 15, 2021
TodayJul 2, 2026
Enrollment to primary: 12 monthsPosted 6.1 years ago
Interventions
011516X (New Artificial Tear Formulation)drug
Topical eye drops
Systane Ultra Multidosedrug
Topical eye drops
REFRESH PLUS®drug
Topical eye drops