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ABBV-444

Phase 3

Dry Eye Disease | Small molecule | Ophthalmology |AbbVie Inc.|Last Updated: Jun 17, 2026

Success Probability
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Market & Valuation
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Trial Design
RandomizedDouble-BlindACTIVE_CONTROLLED
Total Trials1
Total Enrollment261
FDA Designations
No designations recorded
Clinical trial landscape

ABBV-444 · 2 trials · 2 indications

Phase 3 2
NCT07284381A 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 DiseaseDry Eye Disease
ACTIVE NOT_RECRUITING261 Analytics
NCT05878067A Study to Assess Symptom Relief and Product Tolerability of ABBV-444 Drops in Adult ParticipantsDry Eye Syndrome
COMPLETED40 Analytics
PHASE3ACTIVE NOT_RECRUITING
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
Dry Eye DiseaseUnlock trial analytics
PHASE3COMPLETED
A Study to Assess Symptom Relief and Product Tolerability of ABBV-444 Drops in Adult Participants
Dry Eye SyndromeUnlock trial analytics
Study Endpoints
Primary Endpoints
Change from Baseline in Ocular Surface Disease Index (OSDI) Score
Baseline to Day 90

The OSDI is a 12-question survey for patients to document their dry eye disease symptoms. The OSDI consists of a 5- point scale (0=none of the time to 4=all of the time), with higher scores representing worse symptoms. The scores are totaled over the 12 questions and converted to a score of 0-100 (0=no symptom to 100=worst symptom). A negative number change from baseline represents an improvement.

Number of Participants with Adverse Events (AEs)
Baseline to Day 90

An AE is defined as any untoward medical occurrence in a patient or clinical investigation in which a participant is administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment.

Change From Baseline to Day 30 in Ocular Surface Disease Index (OSDI) Score
Baseline to Day 30

The OSDI is a 12-question survey for participants to document their dry eye disease symptoms. The OSDI consists of a 5-point scale ranging from 0 (none of the time) to 4 (all of the time), with higher scores representing greater disability. The scores from the 12 questions are totaled and converted to an overall score ranging from 0 (no disability) to 100 (complete disability). A negative number change from baseline represents an improvement.

Secondary Endpoints
Change from Baseline in Total Ocular Surface Staining Score (OS Staining) (modified NEI Grid, with fluorescein for cornea; and lissamine green for conjunctiva)
Baseline to Day 90
Change from Baseline in Tear Breakup Time (TBUT) with Fluorescein
Baseline to Day 90
Patient Eye Drop Experience (PEDE) Survey Scores at Day 30 (Visual Analog Scale)
Day 30
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
ABBV-444EXPERIMENTALParticipant will receive ABBV-444 as needed but at least twice a day for 90 days.
REFRESH OPTIVE UDACTIVE_COMPARATORParticipant will receive REFRESH PLUS as needed but at least twice a day for 90 days. (Refresh Plus is the run-in medication for 7-10 days before study treatment assignment)
Interventions
NameTypeDescription
ABBV-444DRUGTopical eye drop
REFRESH OPTIVE UDDRUGTopical eye drop
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Eligibility Criteria
Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites20

Inclusion Criteria: * Ocular Surface Disease Index (OSDI) score of ≥ 28 and ≤ 65 (based upon a 0 to 100 scale) at Screening. (Day -7) and an OSDI score of ≥ 18 and ≤ 65 (based upon a 0 to 100 scale) at Baseline (Day 1). * Three consecutive tear breakup time (TBUT) tests of ≤ 10 seconds in at least ...

Countries:United States
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Competitive Landscape -Dry Eye Disease 8 trials
Recent Changes (Last 90 Days)
MEDIUMJun 18, 2026NCT07284381Status: RECRUITING → ACTIVE_NOT_RECRUITING
MEDIUMJun 18, 2026NCT07284381Status: RECRUITING → ACTIVE_NOT_RECRUITING
MEDIUMJun 18, 2026NCT07284381Status: RECRUITING → ACTIVE_NOT_RECRUITING
MEDIUMJun 18, 2026NCT07284381Status: RECRUITING → ACTIVE_NOT_RECRUITING
LOWMay 26, 2026NCT07284381primaryCompletionDate: changed
LOWMay 24, 2026NCT07284381studyFirstPostDate: changed