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

Last updated: March 9, 2026
Sponsor: AbbVie
Overall Status: Active - Recruiting

Phase

3

Condition

Dry Eye Disease

Treatment

ABBV-444

REFRESH OPTIVE UD

Clinical Study ID

NCT07284381
M23-730
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Ocular Surface Disease Index (OSDI) score of ≥ 28 and ≤ 65 (based upon a 0 to 100scale) 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 eyeat 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 areasexamined) 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 ofScreening (Day -7) Visit.

Exclusion

Exclusion Criteria:

  • Participant has uncontrolled severe systemic disease that, in the assessment of theinvestigator, would put safety of the subject at risk through participation, orwhich would prevent or confound protocol-specified assessments (e.g., hypertensionand diabetes, Sjögren's syndrome, rheumatoid arthritis, systemic lupuserythematosus, 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 inthe investigator's opinion, may impact the participant's study participation.

Study Design

Total Participants: 250
Treatment Group(s): 2
Primary Treatment: ABBV-444
Phase: 3
Study Start date:
December 15, 2025
Estimated Completion Date:
November 30, 2026

Connect with a study center

  • Trinity Research Group /ID# 279914

    Dothan, Alabama 36301
    United States

    Active - Recruiting

  • Trinity Research Group /ID# 279914

    Dothan 4059102, Alabama 4829764 36301
    United States

    Site Not Available

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

    Chandler, Arizona 85224
    United States

    Active - Recruiting

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

    Chandler 5289282, Arizona 5551752 85224
    United States

    Site Not Available

  • Canyon City Eyecare /ID# 267948

    Azusa, California 91702
    United States

    Active - Recruiting

  • Global Research Management /ID# 267980

    Glendale, California 91204
    United States

    Active - Recruiting

  • Lakeside Vision Center /ID# 268544

    Irvine, California 92604
    United States

    Active - Recruiting

  • Eye Research Foundation /ID# 267931

    Newport Beach, California 92663
    United States

    Active - Recruiting

  • Canyon City Eyecare /ID# 267948

    Azusa 5325423, California 5332921 91702
    United States

    Site Not Available

  • Global Research Management /ID# 267980

    Glendale 5352423, California 5332921 91204
    United States

    Site Not Available

  • Lakeside Vision Center /ID# 268544

    Irvine 5359777, California 5332921 92604
    United States

    Site Not Available

  • Eye Research Foundation /ID# 267931

    Newport Beach 5376890, California 5332921 92663
    United States

    Site Not Available

  • Lee Shettle Eye and Hearing /ID# 268118

    Largo, Florida 33773
    United States

    Active - Recruiting

  • Lee Shettle Eye and Hearing /ID# 268118

    Largo 4161580, Florida 4155751 33773
    United States

    Site Not Available

  • Clayton Eye Center /ID# 268097

    Morrow, Georgia 30260
    United States

    Active - Recruiting

  • Coastal Research Associates - Roswell /ID# 279915

    Roswell, Georgia 30076
    United States

    Active - Recruiting

  • Clayton Eye Center /ID# 268097

    Morrow 4210254, Georgia 4197000 30260
    United States

    Site Not Available

  • Coastal Research Associates - Roswell /ID# 279915

    Roswell 4219934, Georgia 4197000 30076
    United States

    Site Not Available

  • Kannarr Eye Care /ID# 267979

    Pittsburg, Kansas 66762
    United States

    Active - Recruiting

  • Butchertown Clinical Trials /ID# 267887

    Louisville, Kentucky 40206
    United States

    Active - Recruiting

  • Butchertown Clinical Trials /ID# 267887

    Louisville 4299276, Kentucky 6254925 40206
    United States

    Site Not Available

  • Moyes Eye Centers /ID# 267944

    Kansas City, Missouri 64154
    United States

    Active - Recruiting

  • Moyes Eye Centers /ID# 267944

    Kansas City 4393217, Missouri 4398678 64154
    United States

    Site Not Available

  • Northern New Jersey Eye Institute /ID# 267974

    South Orange, New Jersey 07079
    United States

    Active - Recruiting

  • Northern New Jersey Eye Institute /ID# 267974

    South Orange 5104836, New Jersey 5101760 07079
    United States

    Site Not Available

  • Core Inc /ID# 267946

    Shelby, North Carolina 28150
    United States

    Active - Recruiting

  • Core Inc /ID# 267946

    Shelby 4491180, North Carolina 4482348 28150
    United States

    Site Not Available

  • Scott and Christie and Associates /ID# 268119

    Cranberry Township, Pennsylvania 16066
    United States

    Active - Recruiting

  • Scott and Christie and Associates /ID# 268119

    Cranberry Township 8643098, Pennsylvania 6254927 16066
    United States

    Site Not Available

  • Southern College of Optometry /ID# 267971

    Memphis, Tennessee 38104
    United States

    Active - Recruiting

  • Total Eye Care - Memphis /ID# 268327

    Memphis, Tennessee 38119
    United States

    Active - Recruiting

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

    Smyrna, Tennessee 37167
    United States

    Active - Recruiting

  • Southern College of Optometry /ID# 267971

    Memphis 4641239, Tennessee 4662168 38104
    United States

    Site Not Available

  • Total Eye Care - Memphis /ID# 268327

    Memphis 4641239, Tennessee 4662168 38119
    United States

    Active - Recruiting

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

    Smyrna 4658590, Tennessee 4662168 37167
    United States

    Site Not Available

  • Piedmont Eye Center /ID# 267929

    Lynchburg, Virginia 24502
    United States

    Active - Recruiting

  • Piedmont Eye Center /ID# 267929

    Lynchburg 4771075, Virginia 6254928 24502
    United States

    Site Not Available

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