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A Clinical Study to Evaluate the Effect and Side Effect of a New Artificial Tear Formulation (ABBV-444) Compared to Refresh Optive Unit Dose in Adult Participants With Dry Eye Disease

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NCT07284381 · readout ≤ 12 d

Sponsored by AbbVie (industry) · ABBV — their whole pipeline →.

Phase
Phase 3
Status
Active, not recruiting
Study type
Interventional
Design
Randomized · Double · Treatment
Enrollment
261actual
Sites
20
Country
United States

Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →

Source: ClinicalTrials.gov, retrieved 2026-08-19

Dates

each axis at the precision it was filed, with the registry's own basis
DateFiledBasisWhat it is
Start2025-12-15actualWhen the study began enrolling
Primary completionAug 2026estimatedThe date the last participant is measured for the primary outcome — the readout window
Study completionAug 2026estimatedThe whole study's end, after follow-up
First posted2025-12-16actualWhen this record first appeared on the registry
Results postedWhen the sponsor posted results to the registry
Record updated2026-06-17actualThe sponsor's own last edit to this record — every projection above is as current as this date

What it studies

Condition

  • Dry Eye Disease

Interventions

  • Drug: ABBV-444
  • Drug: REFRESH OPTIVE UD

Primary outcomes

what the primary-completion date above is the date OF
Change from Baseline in Ocular Surface Disease Index (OSDI) Score
measured Baseline to Day 90
Number of Participants with Adverse Events (AEs)
measured Baseline to Day 90

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