Clinical trial NCT05878067: A Study to Assess Symptom Relief and Product Tolerability of ABBV-444 Drops in Adult Participants
Official title: A Patient Experience Study With ABBV-444 for Symptom Relief and Tolerability
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Dry Eye Syndrome
Keywords: Dry Eye Syndrome
ABBV-444
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2023-05-26
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Change From Baseline to Day 30 in Ocular Surface Disease Index (OSDI) Score
timeFrame: Baseline to Day 30
Secondary outcomes:
measure: Patient Eye Drop Experience (PEDE) Survey Scores at Day 30 (Visual Analog Scale)
timeFrame: Day 30
measure: Change From Baseline in Symptom Scores (Visual Analog Scale) Within 5 Minutes Post Administration of ABBV-444
timeFrame: Baseline (T0) to 5 minutes (T5)
Other outcomes:
Locations:
city: Azusa
country: United States
facility: Canyon City Eyecare /ID# 253652
state: California
Study officials:
affiliation: AbbVie
name: ABBVIE INC.
role: STUDY_DIRECTOR
References: