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ABBV-444 Drops for Dry Eye Syndrome

Phase 3
Waitlist Available
Research Sponsored by AbbVie
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline (t0) to 5 minutes (t5)
Awards & highlights
No Placebo-Only Group
Pivotal Trial

Summary

This trial is testing ABBV-444 eye drops to help adults with Dry Eye Disease. The drops aim to keep eyes moist and reduce irritation by improving tear quality and reducing swelling. Participants will use the drops daily for a period and attend check-ups to monitor their progress.

Eligible Conditions
  • Dry Eye Syndrome

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline (t0) to 5 minutes (t5)
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline (t0) to 5 minutes (t5) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change From Baseline to Day 30 in Ocular Surface Disease Index (OSDI) Score
Secondary study objectives
Change From Baseline in Symptom Scores (Visual Analog Scale) Within 5 Minutes Post Administration of ABBV-444
Patient Eye Drop Experience (PEDE) Survey Scores at Day 30 (Visual Analog Scale)

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

1Treatment groups
Experimental Treatment
Group I: ABBV-444Experimental Treatment1 Intervention
Participants will administer 1-2 drops of ABBV-444 in each eye as needed but minimally twice a day for 30 days.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
ABBV-444
2023
Completed Phase 3
~40

Find a Location

Who is running the clinical trial?

AbbVieLead Sponsor
1,031 Previous Clinical Trials
521,700 Total Patients Enrolled
ABBVIE INC.Study DirectorAbbVie
452 Previous Clinical Trials
162,186 Total Patients Enrolled

Media Library

ABBV-444 (Other) Clinical Trial Eligibility Overview. Trial Name: NCT05878067 — Phase 3
Dry Eye Syndrome Research Study Groups: ABBV-444
Dry Eye Syndrome Clinical Trial 2023: ABBV-444 Highlights & Side Effects. Trial Name: NCT05878067 — Phase 3
ABBV-444 (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05878067 — Phase 3
~17 spots leftby Dec 2025
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