Trial Outcomes & Findings for A Study to Assess Symptom Relief and Product Tolerability of ABBV-444 Drops in Adult Participants (NCT NCT05878067)
NCT ID: NCT05878067
Last Updated: 2024-10-15
Results Overview
The OSDI is a 12-question survey for participants to document their dry eye disease symptoms. The OSDI consists of a 5-point scale ranging from 0 (none of the time) to 4 (all of the time), with higher scores representing greater disability. The scores from the 12 questions are totaled and converted to an overall score ranging from 0 (no disability) to 100 (complete disability). A negative number change from baseline represents an improvement.
COMPLETED
PHASE3
40 participants
Baseline to Day 30
2024-10-15
Participant Flow
A total of 40 participants were enrolled and included in the intent-to-treat (ITT) population. The per-protocol (PP) population included 34 participants after excluding 4 participants who were deemed protocol deviations and 2 participants who discontinued the study. The per-protocol population was used for all efficacy measures.
Four participants were deemed protocol deviations following data entry and analysis because their baseline OSDI scores were outside the 18 to 65 inclusion range. The 4 participants were not included in the per protocol population.
Participant milestones
| Measure |
ABBV-444
Participants administered 1-2 drops of ABBV-444 in each eye as needed but minimally twice a day for 30 days.
ABBV-444: Lubricant Eye drops
|
|---|---|
|
Overall Study
STARTED
|
40
|
|
Overall Study
COMPLETED
|
38
|
|
Overall Study
NOT COMPLETED
|
2
|
Reasons for withdrawal
| Measure |
ABBV-444
Participants administered 1-2 drops of ABBV-444 in each eye as needed but minimally twice a day for 30 days.
ABBV-444: Lubricant Eye drops
|
|---|---|
|
Overall Study
Lost to Follow-up
|
2
|
Baseline Characteristics
A Study to Assess Symptom Relief and Product Tolerability of ABBV-444 Drops in Adult Participants
Baseline characteristics by cohort
| Measure |
ABBV-444
n=40 Participants
Participants administered 1-2 drops of ABBV-444 in each eye as needed, but minimally twice a day for 30 days.
|
|---|---|
|
Age, Continuous
|
37.7 years
STANDARD_DEVIATION 15.8 • n=5 Participants
|
|
Sex: Female, Male
Female
|
24 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
16 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
38 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
2 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
38 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline to Day 30Population: The analysis is based on the full analysis set (FAS), consisting of all participants who were eligible based on the inclusion and exclusion criteria and completed 30 days of treatment for this study.
The OSDI is a 12-question survey for participants to document their dry eye disease symptoms. The OSDI consists of a 5-point scale ranging from 0 (none of the time) to 4 (all of the time), with higher scores representing greater disability. The scores from the 12 questions are totaled and converted to an overall score ranging from 0 (no disability) to 100 (complete disability). A negative number change from baseline represents an improvement.
Outcome measures
| Measure |
ABBV-444
n=34 Participants
Participants administered 1-2 drops of ABBV-444 in each eye as needed but minimally twice a day for 30 days.
|
|---|---|
|
Change From Baseline to Day 30 in Ocular Surface Disease Index (OSDI) Score
|
-6.8 score on a scale
Standard Deviation 15.0
|
SECONDARY outcome
Timeframe: Day 30Population: The analysis is based on the full analysis set (FAS), consisting of all participants who were eligible based on the inclusion and exclusion criteria and completed 30 days of treatment for this study.
The PEDE 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 ranging from 0 (strongly disagree) to 100 (strongly agree). On Day 30, participants were asked to retrospectively recall their experiences after 5 minutes, 30 minutes, 24 hours, and 5 days of when they administered the eye drops
Outcome measures
| Measure |
ABBV-444
n=34 Participants
Participants administered 1-2 drops of ABBV-444 in each eye as needed but minimally twice a day for 30 days.
|
|---|---|
|
Patient Eye Drop Experience (PEDE) Survey Scores at Day 30 (Visual Analog Scale)
The study eye drops do not cause stinging or burning in my eyes (5 minutes)
|
76.4 score on a scale
Standard Deviation 36.7
|
|
Patient Eye Drop Experience (PEDE) Survey Scores at Day 30 (Visual Analog Scale)
Study eye drops provided immediate relief of my eye dryness when putting in my eyes (5 minutes)
|
77.1 score on a scale
Standard Deviation 27.9
|
|
Patient Eye Drop Experience (PEDE) Survey Scores at Day 30 (Visual Analog Scale)
Study eye drops immediately soothed my eye dryness when putting in my eyes (5 minutes)
|
81.3 score on a scale
Standard Deviation 25.3
|
|
Patient Eye Drop Experience (PEDE) Survey Scores at Day 30 (Visual Analog Scale)
Did not experience much blurry/fluctuating vision after putting study eye drops in my eyes (5 mins)
|
77.5 score on a scale
Standard Deviation 30.4
|
|
Patient Eye Drop Experience (PEDE) Survey Scores at Day 30 (Visual Analog Scale)
Study eye drops provided immediate comfort to my eye dryness when putting in my eyes (5 minutes)
|
84.1 score on a scale
Standard Deviation 21.1
|
|
Patient Eye Drop Experience (PEDE) Survey Scores at Day 30 (Visual Analog Scale)
The study eye drops are very soothing for my eye dryness (30 minutes)
|
82.0 score on a scale
Standard Deviation 25.6
|
|
Patient Eye Drop Experience (PEDE) Survey Scores at Day 30 (Visual Analog Scale)
The study eye drops did not feel sticky (30 minutes)
|
78.6 score on a scale
Standard Deviation 30.8
|
|
Patient Eye Drop Experience (PEDE) Survey Scores at Day 30 (Visual Analog Scale)
The study eye drops continued to provide relief of my eye discomfort (30 minutes)
|
84.6 score on a scale
Standard Deviation 20.7
|
|
Patient Eye Drop Experience (PEDE) Survey Scores at Day 30 (Visual Analog Scale)
The study eye drops continued to provide comfort to my eye dryness (30 minutes)
|
85.7 score on a scale
Standard Deviation 21.0
|
|
Patient Eye Drop Experience (PEDE) Survey Scores at Day 30 (Visual Analog Scale)
The study eye drops provided relief of my eye dryness day and night (24 hours)
|
84.4 score on a scale
Standard Deviation 20.0
|
|
Patient Eye Drop Experience (PEDE) Survey Scores at Day 30 (Visual Analog Scale)
The study eye drops provided comfort to my eye dryness day and night (24 hours)
|
84.5 score on a scale
Standard Deviation 21.5
|
|
Patient Eye Drop Experience (PEDE) Survey Scores at Day 30 (Visual Analog Scale)
The study eye drops provided lasting relief of my eye dryness (5 days)
|
83.8 score on a scale
Standard Deviation 23.2
|
|
Patient Eye Drop Experience (PEDE) Survey Scores at Day 30 (Visual Analog Scale)
The study eye drops have provided relief during conditions that lead to eye dryness (5 days)
|
82.0 score on a scale
Standard Deviation 22.6
|
SECONDARY outcome
Timeframe: Baseline (T0) to 5 minutes (T5)Population: The analysis is based on the full analysis set (FAS), consisting of all participants who were eligible based on the inclusion and exclusion criteria and completed 30 days of treatment for this study.
The Current Symptom Survey is a 5-item questionnaire where the participants rate their ocular symptoms at the present moment using a scale ranging from 0 (strongly disagree) to 100 (strongly agree). Surveys were completed 5 minutes following the first administration of study eye drops. A negative number change from baseline represents an improvement.
Outcome measures
| Measure |
ABBV-444
n=34 Participants
Participants administered 1-2 drops of ABBV-444 in each eye as needed but minimally twice a day for 30 days.
|
|---|---|
|
Change From Baseline in Symptom Scores (Visual Analog Scale) Within 5 Minutes Post Administration of ABBV-444
|
-10.1 score on a scale
Standard Deviation 10.6
|
Adverse Events
ABBV-444
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee AbbVie requests that any investigator or institution that plans on presenting/publishing results disclosure, provide written notification of their request 60 days prior to their presentation/publication. AbbVie requests that no presentation/publication will be instituted until 12 months after a study is completed, or after the first presentation/publication whichever occurs first. A delay may be proposed of a presentation/publication if AbbVie needs to secure patent or proprietary protection.
- Publication restrictions are in place
Restriction type: OTHER