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The purpose of this study is to evaluate night-driving performance in real-world driving conditions in participants with presbyopia treated with AGN-190584 versus vehicle. Adverse events and change in disease symptoms will be assessed.
AGN-190584 is an investigational formulation of pilocarpine for treating symptoms associated with presbyopia as a topical, once-daily eyedrop delivered by a proprietary vehicle.
This crossover study consists of two parts. Part 1 consists of Visit 2 and Visit 3, and Part 2 consists of Visit 4 and Visit 5. Approximately half of the participants will receive AGN-190584 at Visit 2 through Visit 3 (Sequence 1 participants) and the remaining participants (Sequence 2 participants) will receive AGN-190584 at Visit 4 through Visit 5. All participants will receive AGN-190584 at home as instructed. Approximately 54 adult participants with presbyopia will be enrolled at 1 site in Australia.
Treatment duration is expected to be no more than 71 days. In Part 1, at Visit 2 (Day 1) and at home as instructed for 7 to 14 days, Sequence 1 participants will receive 1 eyedrop of AGN-190584 in each eye and Sequence 2 participants will receive 1 eyedrop of vehicle in each eye. All participants will have a driving assessment at Visit 3 (Day 8 to 15). In Part 2, at Visit 4 (Day 15 to 57) and at home as instructed for 7 to 14 days, Sequence 2 participants will receive 1 eyedrop of AGN-190584 in each eye and Sequence 1 participants will receive 1 eyedrop of vehicle in each eye. All participants will have a driving assessment at Visit 5 (Day 22 to 71).
There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the course of the study at a hospital or clinic. The effects of the treatment will be checked by medical assessments, asking about side effects, and completing questionnaires.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AGN-190584 Sequence 1 | Experimental | AGN-190584 Sequence 1 (Participants will receive AGN-190584 from Visit 2 through Visit 3 followed by Vehicle from Visit 4 through Visit 5). |
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| AGN-190584 Sequence 2 | Experimental | AGN-190584 Sequence 2 (Participants will receive Vehicle from Visit 2 through Visit 3 followed by AGN-190584 from Visit 4 through Visit 5). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AGN-190584 | Drug | Topical eyedrop |
|
| Measure | Description | Time Frame |
|---|---|---|
| Overall Composite Driving Z Score Approximately 1 Hour After Study Intervention Instillation | 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. | One hour after study intervention instillation at Visit 3 (Day 8 to 15) and at Visit 5 (Day 22 to 71) |
| Number of Participants With Adverse Events | 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. | Enrollment to Day 71 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| ABBVIE INC. | AbbVie | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| School of Optometry and Vision Science, Queensland University of Technology /ID# 226378 | Brisbane | Queensland | 4059 | Australia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38044272 | Derived | Waring GO 4th, Brujic M, McGee S, Micheletti JM, Zhao C, Schachter S, Liu H, Safyan E. Impact of presbyopia treatment pilocarpine hydrochloride 1.25% on night-driving performance. Clin Exp Optom. 2024 Aug;107(6):665-672. doi: 10.1080/08164622.2023.2279189. Epub 2023 Dec 3. |
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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.
For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/
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/
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.
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Period 1 |
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| Period 2 |
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The ITT population includes all randomized participants.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | Vehicle - AGN-190584 (Sequence 2) |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Overall Composite Driving Z Score Approximately 1 Hour After Study Intervention Instillation | 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. | 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. | Posted | Mean | Standard Deviation | Z-score | One hour after study intervention instillation at Visit 3 (Day 8 to 15) and at Visit 5 (Day 22 to 71) |
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.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Period 1 (Vehicle) | Participants received Vehicle from Visit 2 through Visit 3 in Period 1. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| DRY EYE | Eye disorders | MedDRA 24.1 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Global Medical Services | AbbVie | 800-633-9110 | abbvieclinicaltrials@abbvie.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Oct 28, 2021 | Aug 5, 2024 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jul 26, 2021 | Aug 5, 2024 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D011305 | Presbyopia |
| ID | Term |
|---|---|
| D012030 | Refractive Errors |
| D005128 | Eye Diseases |
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| ID | Term |
|---|---|
| D010862 | Pilocarpine |
| ID | Term |
|---|---|
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
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| Vehicle | Drug | Topical eyedrop |
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| NOT COMPLETED |
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Participants will receive Vehicle from Visit 2 through Visit 3 followed by AGN-190584 from Visit 4 through Visit 5.
| BG002 | Total | Total of all reporting groups |
| Participants |
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| Age, Continuous | Mean | Standard Deviation | Years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Primary | Number of Participants With Adverse Events | 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. | The safety population includes all treated participants who receive ≥ 1 administration of study intervention. | Posted | Count of Participants | Participants | Enrollment to Day 71 |
|
|
|
| 0 |
| 21 |
| 0 |
| 21 |
| 2 |
| 21 |
| EG001 | Period 1 (AGN-190584) | Participants received AGN-190584 from Visit 2 through Visit 3 in Period 1. | 0 | 22 | 0 | 22 | 14 | 22 |
| EG002 | Period 2 (Vehicle to AGN-190584) | Participants received AGN-190584 from Visit 4 through Visit 5 in Period 2. | 0 | 21 | 0 | 21 | 15 | 21 |
| EG003 | Period 2 (AGN-190584 to Vehicle) | Participants received Vehicle from from Visit 4 through Visit 5 in Period 2. | 0 | 22 | 0 | 22 | 3 | 22 |
| EYE PAIN | Eye disorders | MedDRA 24.1 | Systematic Assessment |
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| OCULAR HYPERAEMIA | Eye disorders | MedDRA 24.1 | Systematic Assessment |
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| PHOTOPHOBIA | Eye disorders | MedDRA 24.1 | Systematic Assessment |
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| VISION BLURRED | Eye disorders | MedDRA 24.1 | Systematic Assessment |
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| VISUAL IMPAIRMENT | Eye disorders | MedDRA 24.1 | Systematic Assessment |
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| NAUSEA | Gastrointestinal disorders | MedDRA 24.1 | Systematic Assessment |
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| HEADACHE | Nervous system disorders | MedDRA 24.1 | Systematic Assessment |
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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.