Actively Recruiting
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
Led by AbbVie · Updated on 2026-03-13
250
Participants Needed
20
Research Sites
45 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official 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...
- Adults aged 18 years or older
- Ocular Surface Disease Index (OSDI) score between 28 and 65 at screening and between 18 and 65 at baseline
- Three consecutive tear breakup time tests of 10 seconds or less in at least one eye at screening and baseline
- Grade 1 to 4 staining in at least one area of the cornea or conjunctiva related to dry eye at screening and baseline
- Use of artificial tear products for dry eye disease within 6 months before screening
You will not qualify if you...
- Uncontrolled severe systemic diseases that may risk safety or affect study assessments (e.g., hypertension, diabetes, Sjögren's syndrome, rheumatoid arthritis, lupus, immunodeficiency)
- Wearing contact lenses in the 90 days before screening or anticipating contact lens use during the study
- Scheduled or planned systemic surgery or procedures during the study that could affect participation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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