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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-06-27

Study Completion Date

2023-10-06

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.

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Detailed Description

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Conditions

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Dry Eye Syndrome

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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ABBV-444

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

Group Type EXPERIMENTAL

ABBV-444

Intervention Type DRUG

Lubricant Eye drops

Interventions

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ABBV-444

Lubricant Eye drops

Intervention Type DRUG

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No