Active — Not RecruitingPhase 3

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

United States261 participantsStarted 2025-12-15

Plain-language summary

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 can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Ocular Surface Disease Index (OSDI) score of ≥ 28 and ≤ 65 (based upon a 0 to 100 scale) at Screening. (Day -7) and an OSDI score of ≥ 18 and ≤ 65 (based upon a 0 to 100 scale) at Baseline (Day 1). * 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 uncontrolled severe systemic disease that, in the assessment of the investigator, would put safety of the subject at risk through participation, or which would prevent or confound protocol-specified assessments (e.g., hypertension and diabetes, Sjögren's syndrome, rheumatoid arthritis, systemic lupus erythematosus, immunodeficiency disease, etc.). * 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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1This trial is in Phase 3 and is comparing ABBV-444 to Refresh Optive, which is already an available over-the-counter artificial tear — what does that comparison tell us about how much is already known about ABBV-444's safety, and what risks might still be uncertain at this stage?
2Since this study is no longer actively recruiting, is there any chance I could still be considered for enrollment, or are there similar trials testing ABBV-444 or other new artificial tear formulations that are still open?
3The trial measures symptom improvement using the OSDI score — given my current dry eye severity and OSDI score, do you think I'd be likely to see meaningful symptom relief from a new artificial tear, or would a different treatment approach make more sense for me first?
4Refresh Optive is the comparator in this trial and is already available without a prescription — is there a reason I shouldn't just try Refresh Optive or another established artificial tear now, rather than waiting to see results from this study?
5What kinds of side effects or adverse events are being specifically tracked in this trial, and are there any early signals from Phase 3 dry eye studies like this one that you'd want me to be aware of before considering ABBV-444 as a future treatment option?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change from Baseline in Ocular Surface Disease Index (OSDI) Score

Timeframe: Baseline to Day 90

Number of Participants with Adverse Events (AEs)

Timeframe: Baseline to Day 90

Trial details

NCT IDNCT07284381

SponsorAbbVie

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-08

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