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

Phase 3

Completed

Brief 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.

Recruitment & Eligibility

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

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Change From Baseline to Day 30 in Ocular Surface Disease Index (OSDI) Score	Baseline to Day 30	The OSDI is a 12-question survey for participants to document their dry eye disease symptoms. The OSDI consists of a 5-point scale ranging from 0 (none of the time) to 4 (all of the time), with higher scores representing greater disability. The scores from the 12 questions are totaled and converted to an overall score ranging from 0 (no disability) to 100 (complete disability). A negative number change from baseline represents an improvement.

Secondary Outcome Measures

Name	Time	Method
Patient Eye Drop Experience (PEDE) Survey Scores at Day 30 (Visual Analog Scale)	Day 30	The PEDE Survey is a 13-item questionnaire that evaluates the short- and long-term subjective experience in comfort and vision as well as tolerability, using a scale ranging from 0 (strongly disagree) to 100 (strongly agree). On Day 30, participants were asked to retrospectively recall their experiences after 5 minutes, 30 minutes, 24 hours, and 5 days of when they administered the eye drops
Change From Baseline in Symptom Scores (Visual Analog Scale) Within 5 Minutes Post Administration of ABBV-444	Baseline (T0) to 5 minutes (T5)	The Current Symptom Survey is a 5-item questionnaire where the participants rate their ocular symptoms at the present moment using a scale ranging from 0 (strongly disagree) to 100 (strongly agree). Surveys were completed 5 minutes following the first administration of study eye drops. A negative number change from baseline represents an improvement.