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Comparing a new artificial tear (ABBV-444) with Refresh Optive for adults with dry eye

A Multicenter, Double-masked, Randomized Study to Compare the Efficacy and Safety of the ABBV-444 Tear Formulation With REFRESH OPTIVE® Unit Dose in Patients With Dry Eye Disease

Phase 3 Interventional AbbVie · NCT07284381

This 90-day test will see if ABBV-444 eye drops relieve symptoms and are as safe or better than Refresh Optive in adults with dry eye.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment250 (estimated)
Ages18 Years and up
SexAll
SponsorAbbVie Industry-sponsored
Locations20 sites (Dothan, Alabama and 19 other locations)
Trial IDNCT07284381 on ClinicalTrials.gov

What this trial studies

This Phase 3 randomized trial plans to enroll about 250 adults with dry eye disease across roughly 20 sites in the United States. After a 7-day run-in using REFRESH PLUS®, eligible participants are randomized to receive either ABBV-444 or REFRESH OPTIVE® Unit Dose eye drops and treated for 90 days. Key outcomes include symptom scores (OSDI), tear breakup time, corneal/conjunctival staining, and safety monitoring to compare effectiveness and tolerability. Participants must meet baseline severity criteria and have used an artificial tear product within the prior six months to qualify.

Who should consider this trial

Good fit: Adults with dry eye who meet the trial's severity criteria—moderate to severe OSDI scores, TBUT ≤ 10 seconds, corneal or conjunctival staining, and recent use of artificial tears—are ideal candidates.

Not a fit: People with uncontrolled severe systemic disease, those who do not meet the specific ocular severity measures, or those with other non‑dry eye ocular conditions may not receive benefit from this intervention.

Why it matters

Potential benefit: If successful, ABBV-444 could provide better or longer-lasting relief from dry eye symptoms with a comparable safety profile to current artificial tears.

How similar studies have performed: Other artificial tear formulations have produced symptom improvements in prior trials, so the general approach is established even though ABBV-444 itself is being tested for the first time at this phase.

Eligibility criteria

Show full inclusion / exclusion criteria 
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 1 eye at both the Screening (Day -7) and Baseline (Day 1) Visits.
* Grade 1 to 4 (modified National Eye Institute \[NEI\] Grid, score range = 0 to 5) staining in at least 1 area of the cornea (5 areas examined) or conjunctiva (6 areas examined) that is related to dry eye in at least 1 eye at both Screening (Day -7) and Baseline (Day 1).
* Have used an artificial tear product for dry eye disease (DED) within 6 months of Screening (Day -7) Visit.

Exclusion Criteria:

* Participant has uncontrolled severe systemic disease that, in the assessment of the investigator, would put safety of the subject at risk through participation, or which would prevent or confound protocol-specified assessments (e.g., hypertension and diabetes, Sjögren's syndrome, rheumatoid arthritis, systemic lupus erythematosus, immunodeficiency disease, etc.).
* Participant has worn contact lenses in the last 90 days prior to the Screening (Day -7) Visit and/or participant anticipates contact lens wear during the study.
* Any scheduled or planned systemic surgery or procedure during the study, which in the investigator's opinion, may impact the participant's study participation.

Where this trial is running

Dothan, Alabama and 19 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Dry Eye DiseaseABBV-444
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.