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

Study Overview
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Brief Summary
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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.

Official Title
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A Patient Experience Study With ABBV-444 for Symptom Relief and Tolerability

Conditions
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Dry Eye Syndrome

Intervention / Treatment
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* Drug: ABBV-444


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ABBV-444<br>Participants will administer 1-2 drops of ABBV-444 in each eye as needed but minimally twice a day for 30 days. | Drug: ABBV-444<br>* Eye drops<br>|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from Baseline in Patient Eye Drop Experiences (Visual Analog Scale) | The Patient Eye Drop Experience 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 where '0 = strongly disagree' and '100 = strongly agree.' | Baseline to Day 30 | 
| Change from Baseline in Symptom Scores (Visual Analog Scale) within 5 Minutes Post Administration of ABBV-444 | The Current Symptom Survey is a 5-item questionnaire where the participants rate their ocular symptoms at the current moment using a scale ranging from '0 = strongly disagree' to '100 = strongly agree.' | Day 1 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Dry Eye Syndrome, ABBV-444