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Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to day 30
Awards & highlights
Study Summary
This trial will test a new drug to treat Dry Eye Disease. 40 adult participants will receive ABBV-444 eye drops as needed for 30 days to evaluate symptoms & tolerability. They will have regular visits & assessments, & may experience higher treatment burden than usual.
Eligible Conditions
- Dry Eye Syndrome
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline to day 30
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to day 30
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change from Baseline in Ocular Surface Disease Index (OSDI) Score
Secondary outcome measures
Change from Baseline in Patient Eye Drop Experiences (Visual Analog Scale)
Change from Baseline in Symptom Scores (Visual Analog Scale) within 5 Minutes Post Administration of ABBV-444
Trial Design
1Treatment groups
Experimental Treatment
Group I: ABBV-444Experimental Treatment1 Intervention
Participants will administer 1-2 drops of ABBV-444 in each eye as needed but minimally twice a day for 30 days.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
ABBV-444
2023
Completed Phase 3
~40
Find a Location
Who is running the clinical trial?
AbbVieLead Sponsor
971 Previous Clinical Trials
505,088 Total Patients Enrolled
ABBVIE INC.Study DirectorAbbVie
406 Previous Clinical Trials
148,977 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:Research Study Groups:
This trial has the following groups:- Group 1: ABBV-444
Awards:
This trial has 2 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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