Trial · NCT04837482

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

NCT04837482, Phase 3, Completed, AbbVie; results first posted 2024-10-10

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. 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. Trials, record NCT04837482. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04837482

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: 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 number: NCT04837482
Status: Completed
Phases: Phase 3
Enrollment: 43 participants, actual
Lead sponsor: AbbVie
Conditions: Presbyopia
Interventions: AGN-190584, Vehicle
First posted: 2021-04-08
Last updated: 2024-10-10
Results first posted: 2024-10-10

Source ClinicalTrials.gov

Registered outcomes2

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Overall Composite Driving Z Score Approximately 1 Hour After Study Intervention Instillation	One hour after study intervention instillation at Visit 3 (Day 8 to 15) and at Visit 5 (Day 22 to 71)	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.
Primary	Number of Participants With Adverse Events	Enrollment to Day 71	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.

Source ClinicalTrials.gov

Outcomes2

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Overall Composite Driving Z Score Approximately 1 Hour After Study Intervention Instillation	One hour after study intervention instillation at Visit 3 (Day 8 to 15) and at Visit 5 (Day 22 to 71)	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.	Z-score	MEAN
PRIMARY	Number of Participants With Adverse Events	Enrollment to Day 71	The safety population includes all treated participants who receive ≥ 1 administration of study intervention.	Participants	COUNT_OF_PARTICIPANTS

Source ClinicalTrials.gov

Results by group4

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
Overall Composite Driving Z Score Approximately 1 Hour After Study Intervention Instillation	Vehicle	0.118	Standard Deviation 0.4011	Z-score
Overall Composite Driving Z Score Approximately 1 Hour After Study Intervention Instillation	AGN-190584	-0.121	Standard Deviation 0.4503	Z-score
Number of Participants With Adverse Events	Vehicle	8		Participants
Number of Participants With Adverse Events	AGN-190584	32		Participants

Source ClinicalTrials.gov

Participant flow12

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Period 1	STARTED	AGN-190584 - Vehicle (Sequence 1)	22
Period 1	STARTED	Vehicle - AGN-190584 (Sequence 2)	21
Period 1	COMPLETED	AGN-190584 - Vehicle (Sequence 1)	22
Period 1	COMPLETED	Vehicle - AGN-190584 (Sequence 2)	21
Period 1	NOT COMPLETED	AGN-190584 - Vehicle (Sequence 1)	0
Period 1	NOT COMPLETED	Vehicle - AGN-190584 (Sequence 2)	0
Period 2	STARTED	AGN-190584 - Vehicle (Sequence 1)	22
Period 2	STARTED	Vehicle - AGN-190584 (Sequence 2)	21
Period 2	COMPLETED	AGN-190584 - Vehicle (Sequence 1)	22
Period 2	COMPLETED	Vehicle - AGN-190584 (Sequence 2)	20

1 to 10 of 12Source ClinicalTrials.gov

See all 12 participant flow

Adverse events32

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	DRY EYE	Eye disorders	Period 1 (Vehicle)	2	21	4
other	DRY EYE	Eye disorders	Period 1 (AGN-190584)	1	22	2
other	DRY EYE	Eye disorders	Period 2 (Vehicle to AGN-190584)	2	21	3
other	DRY EYE	Eye disorders	Period 2 (AGN-190584 to Vehicle)	1	22	2
other	EYE PAIN	Eye disorders	Period 1 (Vehicle)	0	21	0
other	EYE PAIN	Eye disorders	Period 1 (AGN-190584)	2	22	4
other	EYE PAIN	Eye disorders	Period 2 (Vehicle to AGN-190584)	6	21	12
other	EYE PAIN	Eye disorders	Period 2 (AGN-190584 to Vehicle)	0	22	0
other	OCULAR HYPERAEMIA	Eye disorders	Period 1 (Vehicle)	0	21	0
other	OCULAR HYPERAEMIA	Eye disorders	Period 1 (AGN-190584)	1	22	2

1 to 10 of 32Source ClinicalTrials.gov

See all 32 adverse events

Adverse event totals12

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Period 1 (Vehicle)	0	21
Total, all-cause mortality	Period 1 (AGN-190584)	0	22
Total, all-cause mortality	Period 2 (Vehicle to AGN-190584)	0	21
Total, all-cause mortality	Period 2 (AGN-190584 to Vehicle)	0	22
Total, other adverse events	Period 1 (Vehicle)	2	21
Total, other adverse events	Period 1 (AGN-190584)	14	22
Total, other adverse events	Period 2 (Vehicle to AGN-190584)	15	21
Total, other adverse events	Period 2 (AGN-190584 to Vehicle)	3	22
Total, serious adverse events	Period 1 (Vehicle)	0	21
Total, serious adverse events	Period 1 (AGN-190584)	0	22

1 to 10 of 12Source ClinicalTrials.gov

See all 12 adverse event totals

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
38044272	DERIVED

Source PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons1

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison
AGN-190584 vs Vehicle: Number of Participants With Adverse Events

Source Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT04837482

GET https://conductscience.org/api/trials/v1/NCT04837482/events?page=2

API reference For AI assistants