What is ABBV-444 studying for Dry Eye Disease?

ABBV-444 is being studied to evaluate its safety and effectiveness compared to Refresh Optive UD in adults with Dry Eye Disease. This trial aims to understand how well this new artificial tear formulation can improve symptoms and eye surface health. The study is sponsored by AbbVie and involves careful monitoring over 90 days.

Who may be eligible for this Dry Eye Disease clinical trial?

Adults aged 18 years or older diagnosed with Dry Eye Disease may be eligible. Participants should have used artificial tears within 6 months and meet specific eye health criteria. Both men and women can join. Please review eligibility criteria for more details.

Is there any cost to participate in this Dry Eye Disease clinical trial?

Study-related care, including the study drug and all trial visits, is provided at no cost. However, personal travel expenses to attend visits may vary and are not guaranteed to be covered. Participants should plan accordingly.

Actively Recruiting

Phase 3

Age: 18Years +

All Genders

ID07284381

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

Led by AbbVie · Updated on 2026-03-13

250

Participants Needed

Research Sites

N/A

Total Duration

AI-Summary

What this Trial Is About

Dry Eye Disease DED is a long-term condition caused by insufficient lubrication in the eyes due to low tear production or poor tear quality. This study aims to compare the safety and effectiveness of a new artificial tear formulation called ABBV-444 with Refresh Optive UD over a 90-day period in adults diagnosed with DED. The research involves around 250 participants across approximately 20 sites in the US to evaluate these treatments for managing dry eye symptoms. Participants first undergo a 7-day run-in period using REFRESH PLUS eye drops. Those who qualify are then randomly assigned to receive either ABBV-444 or REFRESH OPTIVE Unit Dose eye drops, both given as needed but at least twice daily for 90 days. This double-masked, randomized trial compares these two treatments during the study period to assess their impact on dry eye disease. Throughout the study, participants will attend multiple visits at the study sites for medical assessments and complete questionnaires to monitor treatment effects and side effects. Researchers will measure changes in the Ocular Surface Disease Index OSDI score and track any adverse events from baseline to day 90. Additional evaluations include tear breakup time and ocular surface staining to assess changes in eye surface health during the treatment period.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years +

All Genders

Eligibility Criteria

You may qualify if you...

Ocular Surface Disease Index (OSDI) score between 28 and 65 at Screening and between 18 and 65 at Baseline
Tear breakup time of 10 seconds or less in at least one eye at Screening and Baseline visits
Grade 1 to 4 staining on cornea or conjunctiva related to dry eye in at least one eye at Screening and Baseline
Use of artificial tear product for Dry Eye Disease within 6 months before Screening

You will not qualify if you...

Uncontrolled severe systemic diseases that may affect safety or study assessments, including hypertension, diabetes, Sjögren's syndrome, rheumatoid arthritis, systemic lupus erythematosus, or immunodeficiency
Contact lens use within 90 days before Screening or expected during the study
Scheduled or planned systemic surgery or procedure during the study that may impact participation

Research Team

ABBVIE CALL CENTER

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