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
NCT ID: NCT07284381
Last Updated: 2025-12-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
250 participants
INTERVENTIONAL
2025-12-15
2026-11-30
Brief Summary
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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.
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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ABBV-444
Participant will receive ABBV-444 as needed but at least twice a day for 90 days.
ABBV-444
Topical eye drop
REFRESH OPTIVE UD
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)
REFRESH OPTIVE UD
Topical eye drop
Interventions
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ABBV-444
Topical eye drop
REFRESH OPTIVE UD
Topical eye drop
Eligibility Criteria
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Inclusion Criteria
* 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 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.
18 Years
ALL
No
Sponsors
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AbbVie
INDUSTRY
Responsible Party
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Principal Investigators
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ABBVIE INC.
Role: STUDY_DIRECTOR
AbbVie
Locations
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Global Research Management /ID# 267980
Glendale, California, United States
Lakeside Vision Center /ID# 268544
Irvine, California, United States
Eye Research Foundation /ID# 267931
Newport Beach, California, United States
Total Eye Care - Memphis /ID# 268327
Memphis, Tennessee, United States
Piedmont Eye Center /ID# 267929
Lynchburg, Virginia, United States
Countries
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Central Contacts
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Related Links
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Other Identifiers
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M23-730
Identifier Type: -
Identifier Source: org_study_id