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

Study Identifier
M23-730
CT.gov Identifier
NCT07284381
EudraCT Identifier
Not available
EUCTIS ID
Not available
For general inquiries, please contact

844-663-3742 or [email protected]

Recruiting
Sign up for trial alerts

Study Details

Medical Condition
  • Dry Eye
    • Study Drug
  • ABBV-444
  • REFRESH OPTIVE UD
    • Phase
    Phase 3
    Sex
    Female & Male
    Age
    18+ years
    Inclusion and Exclusion Criteria
    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.

    Protocol 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.

    Study Locations

    Location
    Status
    Location
    Trinity Research Group /ID# 279914
    Dothan, Alabama, United States, 36301
    Status
    Recruiting
    Location
    Arizona Eye Center - West Ray Road /ID# 267993
    Chandler, Arizona, United States, 85224
    Status
    Recruiting
    Location
    Canyon City Eyecare /ID# 267948
    Azusa, California, United States, 91702
    Status
    Recruiting
    Location
    Global Research Management /ID# 267980
    Glendale, California, United States, 91204
    Status
    Recruiting
    Location
    Lakeside Vision Center /ID# 268544
    Irvine, California, United States, 92604
    Status
    Recruiting
    Location
    Eye Research Foundation /ID# 267931
    Newport Beach, California, United States, 92663
    Status
    Recruiting
    Showing {first} - {last} of {total} Results