A Study to Assess Symptom Relief and Product Tolerability of ABBV-444 Drops in Adult Participants

Last updated: September 23, 2024
Sponsor: AbbVie
Overall Status: Completed

Phase

3

Condition

Dry Eye Disease

Sjogren's Syndrome

Eyelid Inflammation

Treatment

ABBV-444

Clinical Study ID

NCT05878067
P24-203
  • Ages > 18
  • All Genders

Study Summary

Dry Eye Disease (DED) is a condition where the tear film of the eye becomes unstable and along with ocular surface inflammation and damage leads to inadequate tear production and eye lubrication. This study will evaluate symptom relief and tolerability of ABBV-444 eye drops in adult participants.

ABBV-444 is being developed for the treatment of Dry Eye Disease (DED). This is a 30-day, open-label study to evaluate adult participant symptoms and tolerability of ABBV-444. Around 40 participants will be enrolled in 1 site in the United States.

Participants will receive 1-2 drops of ABBV-444 in each eye as needed but minimally twice a day for 30 days.

There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, checking for side effects and completing questionnaires.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Had used artificial tears for dry eyes within the past year

  • OSDI score of ≥ 18 and ≤ 65 (based upon a 0 to 100 scale) at Screening and BaselineVisits Three consecutive tear breakup time (TBUT) tests ≤ 10 seconds in at least 1eye at Day -7 (screening)

  • 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 was related to dry eye in at least 1 eye at both at Screening andBaseline Visits

Exclusion

Exclusion Criteria:

  • Have uncontrolled severe systemic disease that, in the assessment of theinvestigator, would put safety of the participant 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.)

  • Known allergy or sensitivity to the study products or their components

  • Schirmer Test (with anesthesia) ≤ 2 mm in either eye at Screening Visit

  • Participant anticipated contact lens wear during the study, or the participant hadworn contact lenses in the last 3 months prior to Screening Visit

Study Design

Total Participants: 40
Treatment Group(s): 1
Primary Treatment: ABBV-444
Phase: 3
Study Start date:
June 27, 2023
Estimated Completion Date:
October 06, 2023

Connect with a study center

  • Canyon City Eyecare /ID# 253652

    Azusa, California 91702
    United States

    Site Not Available

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