ABBV-444 for Dry Eye Syndrome
What You Need to Know Before You Apply
What is the purpose of this trial?
Dry Eye Disease (DED) refers to a long-term condition that happens when there is not enough lubrication in your eyes. This can happen when your eye cannot make enough tears or if you make poor-quality tears. The purpose of this study is to compare the efficacy and safety of a new artificial tear formulation (ABBV-444) with Refresh Optive UD for 90 days in participants with Dry Eye Disease (DED.
ABBV-444 is being developed for the treatment of Dry Eye Disease (DED). Participants will be placed into 1 of 2 treatment arms. Each group receives different treatment. Adult participants diagnosed with dry eye disease will be enrolled. Around 250 participants will be enrolled in the study at approximately 20 sites across the US
In this study, participants first complete a 7-day run-in period using REFRESH PLUS® eye drops. Those eligible are then randomized to receive ABBV-444 eye drops or REFRESH OPTIVE® Unit Dose eye drops. Participants in both arms will receive treatment for a 90-day treatment period.
There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend multiple required study visits during the study at the study site. The effect of the treatment will be checked by medical assessments and questionnaires.
Who Is on the Research Team?
ABBVIE INC.
Principal Investigator
AbbVie
Are You a Good Fit for This Trial?
Adults with Dry Eye Disease (DED) can join this study. They must have completed a 7-day period using REFRESH PLUS eye drops before starting the trial. People who don't meet the specific requirements for DED severity or have other eye conditions that might interfere with the study cannot participate.Inclusion Criteria
Exclusion Criteria
What Are the Treatments Tested in This Trial?
Interventions
- ABBV-444
Trial Overview
The trial is testing a new artificial tear solution, ABBV-444, against Refresh Optive UD to see which one is better at treating dry eyes over a 90-day period. Participants are randomly chosen to use either ABBV-444 or Refresh Optive after an initial run-in phase.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Active Control
Participant will receive ABBV-444 as needed but at least twice a day for 90 days.
Participant 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)
Find a Clinic Near You
Who Is Running the Clinical Trial?
AbbVie
Lead Sponsor
Dr. Roopal Thakkar
AbbVie
Chief Medical Officer since 2023
MD from Wayne State University School of Medicine
Robert A. Michael
AbbVie
Chief Executive Officer
Bachelor's degree in Finance from the University of Illinois
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