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New eye drop aims to soothe dry eyes better than current option

NCT ID NCT07284381

Symptom relief Sponsor: AbbVie Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Sep 18, 2026 · Updated 2 times

Summary

This study tests a new artificial tear called ABBV-444 against an existing brand, Refresh Optive, in 250 adults with dry eye disease. Participants use the assigned eye drops for 90 days. The goal is to see if the new formula improves eye comfort and surface health better than the current standard treatment.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

261 people

The number who actually took part.

Started

Dec 2025

Finished

Aug 2026

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

dry eye syndrome

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Dry eye disease

Contacts and locations

Locations

  • Advancing Vision Research - Smyrna - Stonecrest Parkway /ID# 267939

    Smyrna, Tennessee, 37167, United States

  • Arizona Eye Center - West Ray Road /ID# 267993

    Chandler, Arizona, 85224, United States

  • Butchertown Clinical Trials /ID# 267887

    Louisville, Kentucky, 40206, United States

  • Canyon City Eyecare /ID# 267948

    Azusa, California, 91702, United States

  • Clayton Eye Center /ID# 268097

    Morrow, Georgia, 30260, United States

  • Coastal Research Associates - Roswell /ID# 279915

    Roswell, Georgia, 30076, United States

  • Core Inc /ID# 267946

    Shelby, North Carolina, 28150, United States

  • Eye Research Foundation /ID# 267931

    Newport Beach, California, 92663, United States

  • Global Research Management /ID# 267980

    Glendale, California, 91204, United States

  • Kannarr Eye Care /ID# 267979

    Pittsburg, Kansas, 66762, United States

  • Lakeside Vision Center /ID# 268544

    Irvine, California, 92604, United States

  • Lee Shettle Eye and Hearing /ID# 268118

    Largo, Florida, 33773, United States

  • Moyes Eye Centers /ID# 267944

    Kansas City, Missouri, 64154, United States

  • Northern New Jersey Eye Institute /ID# 267974

    South Orange, New Jersey, 07079, United States

  • Piedmont Eye Center /ID# 267929

    Lynchburg, Virginia, 24502, United States

  • Rochester Ophthalmological Group - Rochester /ID# 268374

    Rochester, New York, 14618, United States

  • Scott and Christie and Associates /ID# 268119

    Cranberry Township, Pennsylvania, 16066, United States

  • Southern College of Optometry /ID# 267971

    Memphis, Tennessee, 38104, United States

  • Total Eye Care - Memphis /ID# 268327

    Memphis, Tennessee, 38119, United States

  • Trinity Research Group /ID# 279914

    Dothan, Alabama, 36301, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.