A Study to Assess Symptom Relief and Product Tolerability of ABBV-444 Drops in Adult Participants
Dry Eye Syndrome
About this trial
This is an interventional treatment trial for Dry Eye Syndrome focused on measuring Dry Eye Syndrome, ABBV-444
Eligibility Criteria
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 Baseline Visits Three consecutive tear breakup time (TBUT) tests ≤ 10 seconds in at least 1 eye 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 areas examined) that was related to dry eye in at least 1 eye at both at Screening and Baseline Visits Exclusion Criteria: Have uncontrolled severe systemic disease that, in the assessment of the investigator, would put safety of the participant 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.) 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 had worn contact lenses in the last 3 months prior to Screening Visit
Sites / Locations
- Canyon City Eyecare /ID# 253652Recruiting
Arms of the Study
Arm 1
Experimental
ABBV-444
Participants will administer 1-2 drops of ABBV-444 in each eye as needed but minimally twice a day for 30 days.