Actively Recruiting
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
20
Research Sites
N/A
Total Duration
On this page
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
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
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 7 to 10 days
Participants use the run-in medication Refresh Plus for 7 to 10 days before starting study treatment.
1 visit (in-person)
Duration - 90 days
Participants receive either ABBV-444 or Refresh Optive Unit Dose eye drops at least twice a day for 90 days.
Regular visits may occur as scheduled by the study team
Trial Site Locations
Total: 20 locations
1
Trinity Research Group /ID# 279914
Dothan, Alabama, United States, 36301
Actively Recruiting
2
Arizona Eye Center - West Ray Road /ID# 267993
Chandler, Arizona, United States, 85224
Actively Recruiting
3
Canyon City Eyecare /ID# 267948
Azusa, California, United States, 91702
Actively Recruiting
4
Global Research Management /ID# 267980
Glendale, California, United States, 91204
Actively Recruiting
5
Lakeside Vision Center /ID# 268544
Irvine, California, United States, 92604
Actively Recruiting
6
Eye Research Foundation /ID# 267931
Newport Beach, California, United States, 92663
Actively Recruiting
7
Lee Shettle Eye and Hearing /ID# 268118
Largo, Florida, United States, 33773
Actively Recruiting
8
Clayton Eye Center /ID# 268097
Morrow, Georgia, United States, 30260
Actively Recruiting
9
Coastal Research Associates - Roswell /ID# 279915
Roswell, Georgia, United States, 30076
Actively Recruiting
10
Kannarr Eye Care /ID# 267979
Pittsburg, Kansas, United States, 66762
Actively Recruiting
11
Butchertown Clinical Trials /ID# 267887
Louisville, Kentucky, United States, 40206
Actively Recruiting
12
Moyes Eye Centers /ID# 267944
Kansas City, Missouri, United States, 64154
Actively Recruiting
13
Northern New Jersey Eye Institute /ID# 267974
South Orange, New Jersey, United States, 07079
Actively Recruiting
14
Rochester Ophthalmological Group - Rochester /ID# 268374
Rochester, New York, United States, 14618
Actively Recruiting
15
Core Inc /ID# 267946
Shelby, North Carolina, United States, 28150
Actively Recruiting
16
Scott and Christie and Associates /ID# 268119
Cranberry Township, Pennsylvania, United States, 16066
Actively Recruiting
17
Southern College of Optometry /ID# 267971
Memphis, Tennessee, United States, 38104
Actively Recruiting
18
Total Eye Care - Memphis /ID# 268327
Memphis, Tennessee, United States, 38119
Actively Recruiting
19
Advancing Vision Research - Smyrna - Stonecrest Parkway /ID# 267939
Smyrna, Tennessee, United States, 37167
Actively Recruiting
20
Piedmont Eye Center /ID# 267929
Lynchburg, Virginia, United States, 24502
Actively Recruiting
Research Team
A
ABBVIE CALL CENTER
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here