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NCT Number: NCT07284381

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

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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Dry Eye Disease Dry Eye Syndromes Eye Diseases Lacrimal Apparatus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Trinity Research Group /ID# 279914, Dothan, Alabama, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

ABBV-444

Drug

Topical eye drop

REFRESH OPTIVE UD

Drug

Topical eye drop

Primary outcomes

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

    Time frame: Baseline to Day 90

    The OSDI is a 12-question survey for patients to document their dry eye disease symptoms. The OSDI consists of a 5- point scale (0=none of the time to 4=all of the time), with higher scores representing worse symptoms. The scores are totaled over the 12 questions and converted to a score of 0-100 (0=no symptom to 100=worst symptom). A negative number change from baseline represents an improvement.

  2. Number of Participants with Adverse Events (AEs)

    Time frame: Baseline to Day 90

    An AE is defined as any untoward medical occurrence in a patient or clinical investigation in which a participant is administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment.

Secondary outcomes

  1. Change from Baseline in Total Ocular Surface Staining Score (OS Staining) (modified NEI Grid, with fluorescein for cornea; and lissamine green for conjunctiva)

    Time frame: Baseline to Day 90

    Corneal staining will be evaluated in each eye at all visits and will be graded 2 minutes after instillation of the fluorescein, during which time TBUT is measured. Grade staining independently approximately 3 minutes in the 5 zones of the cornea (1 through 5) as shown below based upon a 6-point scale (0,

    1, 2, 3, 4, 5) for a maximum grade of 5 in each of the 5 zones (or a total maximal score of 25 for each eye).

  2. Change from Baseline in Tear Breakup Time (TBUT) with Fluorescein

    Time frame: Baseline to Day 90

    The TBUT will be determined during the approximately 3 minutes wait for corneal staining using fluorescein strips moistened with saline drops applied to the treatment area. Participants will be asked to blink normally 2 to 3 times to evenly spread the fluorescein. Then, they will be asked to not blink for as long as they can. As soon as they start holding the blink, the timing with the stopwatch will begin. The stopwatch is stopped on the first occurrence of true tear break-up, not just local thinning or tear film irregularity

Sponsors and collaborators

Lead sponsor

AbbVie

Industry

Registry information

Official study title

A Multicenter, Double-masked, Randomized Study to Compare the Efficacy and Safety of the ABBV-444 Tear Formulation With REFRESH OPTIVE® Unit Dose in Patients With Dry Eye Disease

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Dec 16, 2025
Registry last updated
Jun 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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