Trial Outcomes & Findings for A Study to Assess the Impact and Adverse Events of Topical Eyedrops of AGN-190584 on Night-driving Performance in Participants, 40 to 55 Years of Age (NCT NCT04837482)

Last Updated: 2024-10-10

Results Overview

An overall composite driving Z-score approximately 1 hour after study intervention instillation was derived to capture the overall driving performance of each participant compared with the whole group for the following parameters: percent hazards hit, percent sign recognition and recognition distance, pedestrian recognition distances, and percent of time outside of the lane. For each participant, the Z-score for each task of the driving test was the difference between his/her value and mean value of the assessments of all participants from the pooled data of both periods combined, divided by the standard deviation of all corresponding assessment values. Because a lower percentage of hazards hit, lower percentage of time outside of the driving lane, and a shorter lap duration indicate better driving performance, the Z-scores of these components were reversed (multiplied by -1) before computing the overall composite driving Z-score. A higher Z-score indicates better driving performance.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

43 participants

Primary outcome timeframe

One hour after study intervention instillation at Visit 3 (Day 8 to 15) and at Visit 5 (Day 22 to 71)

Results posted on

2024-10-10

Participant Flow

A total of 43 participants were randomized and treated; 22 to the sequence AGN-190584 followed by vehicle and 21 to the sequence vehicle followed by AGN-190584.

The ITT population includes all randomized participants. The safety population includes all treated participants who received at least one dose of study intervention. All 43 randomized participants were included in both the intent-to-treat (ITT) and safety populations.

Participant milestones

Participant milestones
Measure	AGN-190584 - Vehicle (Sequence 1) Participants will receive AGN-190584 from Visit 2 through Visit 3 followed by Vehicle from Visit 4 through Visit 5.	Vehicle - AGN-190584 (Sequence 2) Participants will receive Vehicle from Visit 2 through Visit 3 followed by AGN-190584 from Visit 4 through Visit 5.
Period 1 STARTED	22	21
Period 1 COMPLETED	22	21
Period 1 NOT COMPLETED	0	0
Period 2 STARTED	22	21
Period 2 COMPLETED	22	20
Period 2 NOT COMPLETED	0	1

Reasons for withdrawal

Reasons for withdrawal
Measure	AGN-190584 - Vehicle (Sequence 1) Participants will receive AGN-190584 from Visit 2 through Visit 3 followed by Vehicle from Visit 4 through Visit 5.	Vehicle - AGN-190584 (Sequence 2) Participants will receive Vehicle from Visit 2 through Visit 3 followed by AGN-190584 from Visit 4 through Visit 5.
Period 2 Withdrawal by Subject	0	1

Baseline Characteristics

A Study to Assess the Impact and Adverse Events of Topical Eyedrops of AGN-190584 on Night-driving Performance in Participants, 40 to 55 Years of Age

Baseline characteristics by cohort

PRIMARY outcome

Timeframe: One hour after study intervention instillation at Visit 3 (Day 8 to 15) and at Visit 5 (Day 22 to 71)

Population: The ITT population includes all randomized participants. The primary efficacy endpoint was analyzed using a linear mixed-effects model with repeated measures (MMRM). Missing data were handled using an MMRM with the missing at random assumption, in which both missingness of data and the correlation of the repeated measurements were considered.

Outcome measures

Outcome measures
Measure	Vehicle n=43 Participants In Sequence 1, participants received AGN-190584 from Visit 2 through Visit 3 followed by Vehicle from Visit 4 through Visit 5. In Sequence 2, participants received Vehicle from Visit 2 through Visit 3 followed by AGN-190584 from Visit 4 through Visit 5.	AGN-190584 n=42 Participants In Sequence 1, participants received AGN-190584 from Visit 2 through Visit 3 followed by Vehicle from Visit 4 through Visit 5. In Sequence 2, participants received Vehicle from Visit 2 through Visit 3 followed by AGN-190584 from Visit 4 through Visit 5.
Overall Composite Driving Z Score Approximately 1 Hour After Study Intervention Instillation	0.118 Z-score Standard Deviation 0.4011	-0.121 Z-score Standard Deviation 0.4503

PRIMARY outcome

Timeframe: Enrollment to Day 71

Population: The safety population includes all treated participants who receive ≥ 1 administration of study intervention.

An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The investigator assesses the relationship of each event to the use of the study intervention. A serious adverse event (SAE) is an event that results in death, is life threatening, requires inpatient hospitalization or prolongs an existing hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event, that based on medical judgment, may jeopardize the participant and may require medical or surgical intervention to prevent any of the outcomes listed above.

Outcome measures

Outcome measures
Measure	Vehicle n=43 Participants In Sequence 1, participants received AGN-190584 from Visit 2 through Visit 3 followed by Vehicle from Visit 4 through Visit 5. In Sequence 2, participants received Vehicle from Visit 2 through Visit 3 followed by AGN-190584 from Visit 4 through Visit 5.	AGN-190584 n=43 Participants In Sequence 1, participants received AGN-190584 from Visit 2 through Visit 3 followed by Vehicle from Visit 4 through Visit 5. In Sequence 2, participants received Vehicle from Visit 2 through Visit 3 followed by AGN-190584 from Visit 4 through Visit 5.
Number of Participants With Adverse Events	8 Participants	32 Participants

Adverse Events

Period 1 (Vehicle)

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Period 1 (AGN-190584)

Serious events: 0 serious events

Other events: 14 other events

Deaths: 0 deaths

Period 2 (Vehicle to AGN-190584)

Serious events: 0 serious events

Other events: 15 other events

Deaths: 0 deaths

Period 2 (AGN-190584 to Vehicle)

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Period 1 (Vehicle) n=21 participants at risk Participants received Vehicle from Visit 2 through Visit 3 in Period 1.	Period 1 (AGN-190584) n=22 participants at risk Participants received AGN-190584 from Visit 2 through Visit 3 in Period 1.	Period 2 (Vehicle to AGN-190584) n=21 participants at risk Participants received AGN-190584 from Visit 4 through Visit 5 in Period 2.	Period 2 (AGN-190584 to Vehicle) n=22 participants at risk Participants received Vehicle from from Visit 4 through Visit 5 in Period 2.
Eye disorders DRY EYE	9.5% 2/21 • Number of events 4 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. The median time participants were followed was 46 days for Period 1 (Vehicle); 37 days for Period 1 (AGN-190504); 8 days for Period 2 (Vehicle to AGN-190584); and 9 days for Period 2 (AGN-190584 to Vehicle). The safety population includes all participants who received at least one dose of study intervention. All 43 randomized participants were included in the safety population.	4.5% 1/22 • Number of events 2 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. The median time participants were followed was 46 days for Period 1 (Vehicle); 37 days for Period 1 (AGN-190504); 8 days for Period 2 (Vehicle to AGN-190584); and 9 days for Period 2 (AGN-190584 to Vehicle). The safety population includes all participants who received at least one dose of study intervention. All 43 randomized participants were included in the safety population.	9.5% 2/21 • Number of events 3 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. The median time participants were followed was 46 days for Period 1 (Vehicle); 37 days for Period 1 (AGN-190504); 8 days for Period 2 (Vehicle to AGN-190584); and 9 days for Period 2 (AGN-190584 to Vehicle). The safety population includes all participants who received at least one dose of study intervention. All 43 randomized participants were included in the safety population.	4.5% 1/22 • Number of events 2 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. The median time participants were followed was 46 days for Period 1 (Vehicle); 37 days for Period 1 (AGN-190504); 8 days for Period 2 (Vehicle to AGN-190584); and 9 days for Period 2 (AGN-190584 to Vehicle). The safety population includes all participants who received at least one dose of study intervention. All 43 randomized participants were included in the safety population.
Eye disorders EYE PAIN	0.00% 0/21 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. The median time participants were followed was 46 days for Period 1 (Vehicle); 37 days for Period 1 (AGN-190504); 8 days for Period 2 (Vehicle to AGN-190584); and 9 days for Period 2 (AGN-190584 to Vehicle). The safety population includes all participants who received at least one dose of study intervention. All 43 randomized participants were included in the safety population.	9.1% 2/22 • Number of events 4 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. The median time participants were followed was 46 days for Period 1 (Vehicle); 37 days for Period 1 (AGN-190504); 8 days for Period 2 (Vehicle to AGN-190584); and 9 days for Period 2 (AGN-190584 to Vehicle). The safety population includes all participants who received at least one dose of study intervention. All 43 randomized participants were included in the safety population.	28.6% 6/21 • Number of events 12 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. The median time participants were followed was 46 days for Period 1 (Vehicle); 37 days for Period 1 (AGN-190504); 8 days for Period 2 (Vehicle to AGN-190584); and 9 days for Period 2 (AGN-190584 to Vehicle). The safety population includes all participants who received at least one dose of study intervention. All 43 randomized participants were included in the safety population.	0.00% 0/22 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. The median time participants were followed was 46 days for Period 1 (Vehicle); 37 days for Period 1 (AGN-190504); 8 days for Period 2 (Vehicle to AGN-190584); and 9 days for Period 2 (AGN-190584 to Vehicle). The safety population includes all participants who received at least one dose of study intervention. All 43 randomized participants were included in the safety population.
Eye disorders OCULAR HYPERAEMIA	0.00% 0/21 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. The median time participants were followed was 46 days for Period 1 (Vehicle); 37 days for Period 1 (AGN-190504); 8 days for Period 2 (Vehicle to AGN-190584); and 9 days for Period 2 (AGN-190584 to Vehicle). The safety population includes all participants who received at least one dose of study intervention. All 43 randomized participants were included in the safety population.	4.5% 1/22 • Number of events 2 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. The median time participants were followed was 46 days for Period 1 (Vehicle); 37 days for Period 1 (AGN-190504); 8 days for Period 2 (Vehicle to AGN-190584); and 9 days for Period 2 (AGN-190584 to Vehicle). The safety population includes all participants who received at least one dose of study intervention. All 43 randomized participants were included in the safety population.	9.5% 2/21 • Number of events 4 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. The median time participants were followed was 46 days for Period 1 (Vehicle); 37 days for Period 1 (AGN-190504); 8 days for Period 2 (Vehicle to AGN-190584); and 9 days for Period 2 (AGN-190584 to Vehicle). The safety population includes all participants who received at least one dose of study intervention. All 43 randomized participants were included in the safety population.	0.00% 0/22 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. The median time participants were followed was 46 days for Period 1 (Vehicle); 37 days for Period 1 (AGN-190504); 8 days for Period 2 (Vehicle to AGN-190584); and 9 days for Period 2 (AGN-190584 to Vehicle). The safety population includes all participants who received at least one dose of study intervention. All 43 randomized participants were included in the safety population.
Eye disorders PHOTOPHOBIA	0.00% 0/21 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. The median time participants were followed was 46 days for Period 1 (Vehicle); 37 days for Period 1 (AGN-190504); 8 days for Period 2 (Vehicle to AGN-190584); and 9 days for Period 2 (AGN-190584 to Vehicle). The safety population includes all participants who received at least one dose of study intervention. All 43 randomized participants were included in the safety population.	0.00% 0/22 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. The median time participants were followed was 46 days for Period 1 (Vehicle); 37 days for Period 1 (AGN-190504); 8 days for Period 2 (Vehicle to AGN-190584); and 9 days for Period 2 (AGN-190584 to Vehicle). The safety population includes all participants who received at least one dose of study intervention. All 43 randomized participants were included in the safety population.	9.5% 2/21 • Number of events 4 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. The median time participants were followed was 46 days for Period 1 (Vehicle); 37 days for Period 1 (AGN-190504); 8 days for Period 2 (Vehicle to AGN-190584); and 9 days for Period 2 (AGN-190584 to Vehicle). The safety population includes all participants who received at least one dose of study intervention. All 43 randomized participants were included in the safety population.	4.5% 1/22 • Number of events 2 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. The median time participants were followed was 46 days for Period 1 (Vehicle); 37 days for Period 1 (AGN-190504); 8 days for Period 2 (Vehicle to AGN-190584); and 9 days for Period 2 (AGN-190584 to Vehicle). The safety population includes all participants who received at least one dose of study intervention. All 43 randomized participants were included in the safety population.
Eye disorders VISION BLURRED	0.00% 0/21 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. The median time participants were followed was 46 days for Period 1 (Vehicle); 37 days for Period 1 (AGN-190504); 8 days for Period 2 (Vehicle to AGN-190584); and 9 days for Period 2 (AGN-190584 to Vehicle). The safety population includes all participants who received at least one dose of study intervention. All 43 randomized participants were included in the safety population.	18.2% 4/22 • Number of events 8 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. The median time participants were followed was 46 days for Period 1 (Vehicle); 37 days for Period 1 (AGN-190504); 8 days for Period 2 (Vehicle to AGN-190584); and 9 days for Period 2 (AGN-190584 to Vehicle). The safety population includes all participants who received at least one dose of study intervention. All 43 randomized participants were included in the safety population.	14.3% 3/21 • Number of events 6 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. The median time participants were followed was 46 days for Period 1 (Vehicle); 37 days for Period 1 (AGN-190504); 8 days for Period 2 (Vehicle to AGN-190584); and 9 days for Period 2 (AGN-190584 to Vehicle). The safety population includes all participants who received at least one dose of study intervention. All 43 randomized participants were included in the safety population.	4.5% 1/22 • Number of events 2 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. The median time participants were followed was 46 days for Period 1 (Vehicle); 37 days for Period 1 (AGN-190504); 8 days for Period 2 (Vehicle to AGN-190584); and 9 days for Period 2 (AGN-190584 to Vehicle). The safety population includes all participants who received at least one dose of study intervention. All 43 randomized participants were included in the safety population.
Eye disorders VISUAL IMPAIRMENT	0.00% 0/21 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. The median time participants were followed was 46 days for Period 1 (Vehicle); 37 days for Period 1 (AGN-190504); 8 days for Period 2 (Vehicle to AGN-190584); and 9 days for Period 2 (AGN-190584 to Vehicle). The safety population includes all participants who received at least one dose of study intervention. All 43 randomized participants were included in the safety population.	27.3% 6/22 • Number of events 14 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. The median time participants were followed was 46 days for Period 1 (Vehicle); 37 days for Period 1 (AGN-190504); 8 days for Period 2 (Vehicle to AGN-190584); and 9 days for Period 2 (AGN-190584 to Vehicle). The safety population includes all participants who received at least one dose of study intervention. All 43 randomized participants were included in the safety population.	28.6% 6/21 • Number of events 12 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. The median time participants were followed was 46 days for Period 1 (Vehicle); 37 days for Period 1 (AGN-190504); 8 days for Period 2 (Vehicle to AGN-190584); and 9 days for Period 2 (AGN-190584 to Vehicle). The safety population includes all participants who received at least one dose of study intervention. All 43 randomized participants were included in the safety population.	0.00% 0/22 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. The median time participants were followed was 46 days for Period 1 (Vehicle); 37 days for Period 1 (AGN-190504); 8 days for Period 2 (Vehicle to AGN-190584); and 9 days for Period 2 (AGN-190584 to Vehicle). The safety population includes all participants who received at least one dose of study intervention. All 43 randomized participants were included in the safety population.
Gastrointestinal disorders NAUSEA	0.00% 0/21 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. The median time participants were followed was 46 days for Period 1 (Vehicle); 37 days for Period 1 (AGN-190504); 8 days for Period 2 (Vehicle to AGN-190584); and 9 days for Period 2 (AGN-190584 to Vehicle). The safety population includes all participants who received at least one dose of study intervention. All 43 randomized participants were included in the safety population.	9.1% 2/22 • Number of events 2 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. The median time participants were followed was 46 days for Period 1 (Vehicle); 37 days for Period 1 (AGN-190504); 8 days for Period 2 (Vehicle to AGN-190584); and 9 days for Period 2 (AGN-190584 to Vehicle). The safety population includes all participants who received at least one dose of study intervention. All 43 randomized participants were included in the safety population.	4.8% 1/21 • Number of events 1 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. The median time participants were followed was 46 days for Period 1 (Vehicle); 37 days for Period 1 (AGN-190504); 8 days for Period 2 (Vehicle to AGN-190584); and 9 days for Period 2 (AGN-190584 to Vehicle). The safety population includes all participants who received at least one dose of study intervention. All 43 randomized participants were included in the safety population.	0.00% 0/22 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. The median time participants were followed was 46 days for Period 1 (Vehicle); 37 days for Period 1 (AGN-190504); 8 days for Period 2 (Vehicle to AGN-190584); and 9 days for Period 2 (AGN-190584 to Vehicle). The safety population includes all participants who received at least one dose of study intervention. All 43 randomized participants were included in the safety population.
Nervous system disorders HEADACHE	0.00% 0/21 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. The median time participants were followed was 46 days for Period 1 (Vehicle); 37 days for Period 1 (AGN-190504); 8 days for Period 2 (Vehicle to AGN-190584); and 9 days for Period 2 (AGN-190584 to Vehicle). The safety population includes all participants who received at least one dose of study intervention. All 43 randomized participants were included in the safety population.	22.7% 5/22 • Number of events 5 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. The median time participants were followed was 46 days for Period 1 (Vehicle); 37 days for Period 1 (AGN-190504); 8 days for Period 2 (Vehicle to AGN-190584); and 9 days for Period 2 (AGN-190584 to Vehicle). The safety population includes all participants who received at least one dose of study intervention. All 43 randomized participants were included in the safety population.	33.3% 7/21 • Number of events 7 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. The median time participants were followed was 46 days for Period 1 (Vehicle); 37 days for Period 1 (AGN-190504); 8 days for Period 2 (Vehicle to AGN-190584); and 9 days for Period 2 (AGN-190584 to Vehicle). The safety population includes all participants who received at least one dose of study intervention. All 43 randomized participants were included in the safety population.	0.00% 0/22 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. The median time participants were followed was 46 days for Period 1 (Vehicle); 37 days for Period 1 (AGN-190504); 8 days for Period 2 (Vehicle to AGN-190584); and 9 days for Period 2 (AGN-190584 to Vehicle). The safety population includes all participants who received at least one dose of study intervention. All 43 randomized participants were included in the safety population.

Additional Information

Global Medical Services

AbbVie

Phone: 800-633-9110

Email: [email protected]

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

Measure	AGN-190584 - Vehicle (Sequence 1) n=22 Participants Participants will receive AGN-190584 from Visit 2 through Visit 3 followed by Vehicle from Visit 4 through Visit 5.	Vehicle - AGN-190584 (Sequence 2) n=21 Participants Participants will receive Vehicle from Visit 2 through Visit 3 followed by AGN-190584 from Visit 4 through Visit 5.	Total n=43 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	22 Participants n=5 Participants	21 Participants n=7 Participants	43 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	50.9 Years STANDARD_DEVIATION 2.92 • n=5 Participants	50.0 Years STANDARD_DEVIATION 4.22 • n=7 Participants	50.5 Years STANDARD_DEVIATION 3.59 • n=5 Participants
Sex: Female, Male Female	13 Participants n=5 Participants	11 Participants n=7 Participants	24 Participants n=5 Participants
Sex: Female, Male Male	9 Participants n=5 Participants	10 Participants n=7 Participants	19 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	22 Participants n=5 Participants	21 Participants n=7 Participants	43 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	2 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	1 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) White	18 Participants n=5 Participants	19 Participants n=7 Participants	37 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants