Back to resultsA Study to Assess Symptom Relief and Product Tolerability of ABBV-444 Drops in Adult Participants
Primary Purpose
Dry Eye Syndrome
Status
Recruiting
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
ABBV-444
Sponsored by
About this trial
This is an interventional treatment trial for Dry Eye Syndrome focused on measuring Dry Eye Syndrome, ABBV-444
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
Sites / Locations
- Canyon City Eyecare /ID# 253652Recruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
ABBV-444
Arm Description
Participants will administer 1-2 drops of ABBV-444 in each eye as needed but minimally twice a day for 30 days.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.'
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.'
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05878067
Brief Title
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
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 27, 2023 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AbbVie
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dry Eye Syndrome
Keywords
Dry Eye Syndrome, ABBV-444
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
ABBV-444
Arm Type
Experimental
Arm Description
Participants will administer 1-2 drops of ABBV-444 in each eye as needed but minimally twice a day for 30 days.
Intervention Type
Drug
Intervention Name(s)
ABBV-444
Intervention Description
Eye drops
Primary Outcome Measure Information:
Title
Change from Baseline in Ocular Surface Disease Index (OSDI) Score
Description
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.
Time Frame
Baseline to Day 30
Secondary Outcome Measure Information:
Title
Change from Baseline in Patient Eye Drop Experiences (Visual Analog Scale)
Description
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.'
Time Frame
Baseline to Day 30
Title
Change from Baseline in Symptom Scores (Visual Analog Scale) within 5 Minutes Post Administration of ABBV-444
Description
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.'
Time Frame
Day 1
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
ABBVIE CALL CENTER
Phone
844-663-3742
Email
abbvieclinicaltrials@abbvie.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
ABBVIE INC.
Organizational Affiliation
AbbVie
Official's Role
Study Director
Facility Information:
Facility Name
Canyon City Eyecare /ID# 253652
City
Azusa
State/Province
California
ZIP/Postal Code
91702
Country
United States
Individual Site Status
Recruiting
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols, analyses plans, clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.
IPD Sharing Time Frame
For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/
IPD Sharing Access Criteria
Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous independent scientific research, and will be provided following review and approval of a research proposal and statistical analysis plan and execution of a data sharing statement. Data requests can be submitted at any time after approval in the US and/or EU and a primary manuscript is accepted for publication. For more information on the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/
IPD Sharing URL
https://vivli.org/ourmember/abbvie/
Links:
URL
https://www.abbvieclinicaltrials.com/study/?id=P24-203
Description
Related Info
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A Study to Assess Symptom Relief and Product Tolerability of ABBV-444 Drops in Adult Participants
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