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Strategic considerations
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The objective of this study is to evaluate the safety, tolerability, pharmacokinetics, and efficacy of AGN-241622 ophthalmic solution for the first time in human participants
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo Dose | Placebo Comparator | Administered as single drop in one or both eyes |
|
| Cohort 1: AGN-241622 Dose 1 (Low Dose) | Experimental | Administered as single drop in one eye |
|
| Cohort 2: AGN-241622 Dose 2 (Medium Dose) | Experimental | Administered as single drop in one eye |
|
| Cohort 3: AGN-241622 Dose 3 (High Dose) | Experimental | Administered as single drop in one eye |
|
| Cohort 4: AGN-241622 Dose 1 (Low Dose) | Experimental | Administered as a single drop in each eye |
|
| Cohort 5: AGN-241622 Dose 2 (Medium Dose) | Experimental | Administered as single drop in each eye |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AGN-241622 | Drug | Topical eye drop |
|
| Measure | Description | Time Frame |
|---|---|---|
| Stage 1: Number of Participants Experiencing a Treatment Emergent Adverse Event After Single Administration of AGN-241622 | The number of participants who experience one or more TEAE during the treatment period | Up to 2 days |
| Stage 2a: Number of Patients Experiencing a Treatment Emergent Adverse Event After Repeat Administration of AGN-241622 | The number of patients who experience one or more TEAE during the treatment period | 14 Days |
| Measure | Description | Time Frame |
|---|---|---|
| Stage 1 Plasma Pharmacokinetics: Terminal Elimination Half-life (T1/2) of AGN-241622 | To evaluate the systemic and local pharmacokinetics of AGN-241622 administered once unilaterally in healthy participants | Day 1 |
| Stage 1 Plasma Pharmacokinetics: Terminal Elimination Rate Constant (λz) of AGN-241622 |
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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 |
|---|---|---|---|---|---|---|
| United Medical Research Institute /ID# 234612 | Inglewood | California | 90301 | United States | ||
| Global Research Foundation /ID# 237353 |
Not provided
| Label | URL |
|---|---|
| Additional information on study locations near you may be found at AllerganClinicalTrials.com. For any study not on AllerganClinicalTrials.com, please contact IR-CTRegistration@Allergan.com for assistance | View source |
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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/
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This study was to be conducted in 3 stages (Stage 1, Stage 2a, and Stage 2b) with participants being randomized to different stages with dose cohorts based on criteria. Due to Sponsor decision, the study was terminated before completion. This decision was not taken due to any safety reasons.
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo Dose | Administered as a single drop in one or both eyes Vehicle: Topical eye drop |
| FG001 | Cohort 1: AGN-241622 Dose 1 (Low Dose) | Administered as single drop in one eye AGN-241622: Topical eye drop |
| FG002 | Cohort 2: AGN-241622 Dose 2 (Medium Dose) | Administered as single drop in one eye AGN-241622: Topical eye drop |
| FG003 | Cohort 3: AGN-241622 Dose 3 (High Dose) | Administered as single drop in one eye AGN-241622: Topical eye drop |
| FG004 | Cohort 4: AGN-241622 Dose 1 (Low Dose) | Administered as a single drop in each eye AGN-241622: Topical eye drop |
| FG005 | Cohort 5: AGN-241622 Dose 2 (Medium Dose) | Administered as single drop in each eye AGN-241622: Topical eye drop |
| FG006 | Cohort 6: AGN-241622 Dose 3 (High Dose) | Administered as single drop in each eye AGN-241622: Topical eye drop |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Stage 1 |
|
| ||||||||||||||||||
| Stage 2A |
|
The intent-to-treat (ITT) population consists of all randomized participants.
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo Dose | Administered as single drop in one or both eyes Vehicle: Topical eye drop |
| BG001 | Cohort 1: AGN-241622 Dose 1 (Low Dose) | Administered as single drop in one eye AGN-241622: Topical eye drop |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | 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 | Stage 1: Number of Participants Experiencing a Treatment Emergent Adverse Event After Single Administration of AGN-241622 | The number of participants who experience one or more TEAE during the treatment period | The safety population consists of all participants who received at least 1 administration of study intervention. Participants will be summarized according to the study intervention they actually received. | Posted | Number | participants | Up to 2 days |
|
Up to 5 Weeks
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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 | Stage 1 Placebo Dose | Administered as single drop in one eye Vehicle: Topical eye drop |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| DRY EYE | Eye disorders | MedDRA 26.0 | 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 | Mar 25, 2020 | Jan 16, 2024 | Prot_002.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jul 12, 2023 | Jan 16, 2024 | SAP_003.pdf |
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| ID | Term |
|---|---|
| D011305 | Presbyopia |
| ID | Term |
|---|---|
| D012030 | Refractive Errors |
| D005128 | Eye Diseases |
Not provided
Not provided
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|
| Cohort 6: AGN-241622 Dose 3 (High Dose) | Experimental | Administered as single drop in each eye |
|
| Vehicle | Drug | Topical eye drop |
|
To evaluate the systemic and local pharmacokinetics of AGN-241622 administered once unilaterally in healthy participants |
| Day 1 |
| Stage 1 Plasma Pharmacokinetics: Maximum Plasma Concentrations (Cmax) of AGN-241622 | To evaluate the systemic and local pharmacokinetics of AGN-241622 administered once unilaterally in healthy participants | Day 1 |
| Stage 1 Plasma Pharmacokinetics: Time of Maximum Plasma Concentrations (Tmax) of AGN-241622 | To evaluate the systemic and local pharmacokinetics of AGN-241622 administered once unilaterally in healthy participants | Day 1 |
| Stage 1 Plasma Pharmacokinetics: Apparent Total Clearance of AGN-241622 From Plasma (CL/F) | To evaluate the systemic and local pharmacokinetics of AGN-241622 administered once unilaterally in healthy participants | Day 1 |
| Stage 1 Plasma Pharmacokinetics: Volume of Distribution During the Terminal Elimination Phase (Vz/F) of AGN-241622 | To evaluate the systemic and local pharmacokinetics of AGN-241622 administered once unilaterally in healthy participants | Day 1 |
| Stage 1 Plasma Pharmacokinetics: Area Under the Concentration-time Curve From Time 0 to Time t (AUC0-t) of AGN-241622 | To evaluate the systemic and local pharmacokinetics of AGN-241622 administered once unilaterally in healthy participants | Day 1 |
| Stage 1 Plasma Pharmacokinetics: Area Under the Concentration-time Curve From Time 0 to Infinity (AUC0-inf) of AGN-241622 | To evaluate the systemic and local pharmacokinetics of AGN-241622 administered once unilaterally in healthy participants | Day 1 |
| Stage 1 Tears Pharmacokinetics: Area Under the Concentration-time Curve From Time 0 to Time t (AUC0-t) of AGN-241622 | To evaluate the systemic and local pharmacokinetics of AGN-241622 administered once unilaterally in healthy participants | Day 1 |
| Stage 1 Tears Pharmacokinetics: Area Under the Concentration-time Curve From Time 0 to Infinity (AUC0-inf) of AGN-241622 | To evaluate the systemic and local pharmacokinetics of AGN-241622 administered once unilaterally in healthy participants | Day 1 |
| Stage 1 Tears Pharmacokinetics: Maximum Plasma Concentrations (Cmax) of AGN-241622 | To evaluate the systemic and local pharmacokinetics of AGN-241622 administered once unilaterally in healthy participants | Day 1 |
| Stage 1 Tears Pharmacokinetics: Time of Maximum Plasma Concentrations (Tmax) of AGN-241622 | To evaluate the systemic and local pharmacokinetics of AGN-241622 administered once unilaterally in healthy participants | Day 1 |
| Stage 1 Tears Pharmacokinetics: Terminal Elimination Rate Constant (λz) of AGN-241622 | To evaluate the systemic and local pharmacokinetics of AGN-241622 administered once unilaterally in healthy participants | Day 1 |
| Stage 1 Tears Pharmacokinetics: Terminal Elimination Half-life (T1/2) of AGN-241622 | To evaluate the systemic and local pharmacokinetics of AGN-241622 administered once unilaterally in healthy participants | Day 1 |
| Stage 1: Pupil Diameter Measurement | To evaluate the target receptor engagement of AGN-241622 as compared with vehicle administered once, unilaterally in healthy participants | Day 1 |
| Stage 2a Plasma Pharmacokinetics: Area Under the Concentration-time Curve From Time 0 to Time t (AUC0-t) of AGN-241622 | To evaluate the systemic and local pharmacokinetics of AGN-241622 after repeat bilateral administration in participants with presbyopia | 14 Days |
| Stage 2a Plasma Pharmacokinetics: Area Under the Plasma/Tear Concentration Versus Time Curve From Time 0 to the End of the Dosing Period (AUC0-tau) of AGN-241622 | To evaluate the systemic and local pharmacokinetics of AGN-241622 after repeat bilateral administration in participants with presbyopia | 14 Days |
| Stage 2a Plasma Pharmacokinetics: Maximum Plasma Concentrations (Cmax) of AGN-241622 | To evaluate the systemic and local pharmacokinetics of AGN-241622 after repeat bilateral administration in participants with presbyopia | 14 Days |
| Stage 2a Plasma Pharmacokinetics: Minimum Plasma Concentrations (Cmin) of AGN-241622 | To evaluate the systemic and local pharmacokinetics of AGN-241622 after repeat bilateral administration in participants with presbyopia | 14 Days |
| Stage 2a Plasma Pharmacokinetics: Time of Maximum Plasma Concentrations (Tmax) of AGN-241622 | To evaluate the systemic and local pharmacokinetics of AGN-241622 after repeat bilateral administration in participants with presbyopia | 14 Days |
| Stage 2a Plasma Pharmacokinetics: Terminal Elimination Rate Constant (λz) of AGN-241622 | To evaluate the systemic and local pharmacokinetics of AGN-241622 after repeat bilateral administration in participants with presbyopia | 14 Days |
| Stage 2a Plasma Pharmacokinetics: Terminal Elimination Half-life (T1/2) of AGN-241622 | To evaluate the systemic and local pharmacokinetics of AGN-241622 after repeat bilateral administration in participants with presbyopia | 14 Days |
| Stage 2a Plasma Pharmacokinetics: Apparent Total Clearance of AGN-241622 From Plasma (CL/F) | To evaluate the systemic and local pharmacokinetics of AGN-241622 after repeat bilateral administration in participants with presbyopia | 14 Days |
| Stage 2a Plasma Pharmacokinetics: Volume of Distribution During the Terminal Elimination Phase (Vz/F) of AGN-241622 | To evaluate the systemic and local pharmacokinetics of AGN-241622 after repeat bilateral administration in participants with presbyopia | 14 Days |
| Stage 2a Plasma Pharmacokinetics: Accumulation Ratio of AGN-241622 | To evaluate the systemic and local pharmacokinetics of AGN-241622 after repeat bilateral administration in participants with presbyopia | 14 Days |
| Stage 2a Tears Pharmacokinetics: Area Under the Concentration-time Curve From Time 0 to Time t (AUC0-t) of AGN-241622 | To evaluate the systemic and local pharmacokinetics of AGN-241622 after repeat bilateral administration in participants with presbyopia | 14 Days |
| Stage 2a Tears Pharmacokinetics: Area Under the Plasma/Tear Concentration Versus Time Curve From Time 0 to the End of the Dosing Period (AUC0-tau) of AGN-241622 | To evaluate the systemic and local pharmacokinetics of AGN-241622 after repeat bilateral administration in participants with presbyopia | 14 Days |
| Stage 2a Tears Pharmacokinetics: Maximum Plasma Concentrations (Cmax) of AGN-241622 | To evaluate the systemic and local pharmacokinetics of AGN-241622 after repeat bilateral administration in participants with presbyopia | 14 Days |
| Stage 2a Tears Pharmacokinetics: Time of Maximum Plasma Concentrations (Tmax) of AGN-241622 | To evaluate the systemic and local pharmacokinetics of AGN-241622 after repeat bilateral administration in participants with presbyopia | 14 Days |
| Stage 2a Tears Pharmacokinetics: Terminal Elimination Rate Constant (λz) of AGN-241622 | To evaluate the systemic and local pharmacokinetics of AGN-241622 after repeat bilateral administration in participants with presbyopia | 14 Days |
| Stage 2a Tears Pharmacokinetics: Terminal Elimination Half-life (T1/2) of AGN-241622 | To evaluate the systemic and local pharmacokinetics of AGN-241622 after repeat bilateral administration in participants with presbyopia | 14 Days |
| Los Angeles |
| California |
| 90041-1718 |
| United States |
| North Valley Eye Medical Group, Inc. /ID# 236686 | Mission Hills | California | 91345-1200 | United States |
| The Eye Research Foundation /ID# 234526 | Newport Beach | California | 92663-3637 | United States |
| Quantum Clinical Trials /ID# 237330 | Miami Beach | Florida | 33140 | United States |
| Kannarr Eye Care /ID# 236718 | Pittsburg | Kansas | 66762-2620 | United States |
| The Eye Care Institute /ID# 234507 | Louisville | Kentucky | 40206 | United States |
| Total Eye Care, PA /ID# 234454 | Memphis | Tennessee | 38119-5745 | United States |
| PPD Clinical Research Unit - Austin /ID# 237644 | Austin | Texas | 78744 | United States |
| Eye associates /ID# 236502 | San Antonio | Texas | 78229 | United States |
| Early termination due to PK tube failure |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
| BG002 | Cohort 2: AGN-241622 Dose 2 (Medium Dose) | Administered as single drop in one eye AGN-241622: Topical eye drop |
| BG003 | Cohort 3: AGN-241622 Dose 3 (High Dose) | Administered as single drop in one eye AGN-241622: Topical eye drop |
| BG004 | Cohort 4: AGN-241622 Dose 1 (Low Dose) | Administered as a single drop in each eye AGN-241622: Topical eye drop |
| BG005 | Cohort 5: AGN-241622 Dose 2 (Medium Dose) | Administered as a single drop in each eye AGN-241622: Topical eye drop |
| BG006 | Cohort 6: AGN-241622 Dose 3 (High Dose) | Administered as a single drop in each eye AGN-241622: Topical eye drop |
| BG007 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| OG002 | Cohort 2: AGN-241622 Dose 2 (Medium Dose) | Administered as single drop in one eye AGN-241622: Topical eye drop |
| OG003 | Cohort 3: AGN-241622 Dose 3 (High Dose) | Administered as single drop in one eye AGN-241622: Topical eye drop |
|
|
| Primary | Stage 2a: Number of Patients Experiencing a Treatment Emergent Adverse Event After Repeat Administration of AGN-241622 | The number of patients who experience one or more TEAE during the treatment period | The safety population consists of all participants who received at least 1 administration of study intervention. Participants will be summarized according to the study intervention they actually received. | Posted | Number | participants | 14 Days |
|
|
|
| Secondary | Stage 1 Plasma Pharmacokinetics: Terminal Elimination Half-life (T1/2) of AGN-241622 | To evaluate the systemic and local pharmacokinetics of AGN-241622 administered once unilaterally in healthy participants | Not Posted | Day 1 | Participants |
| Secondary | Stage 1 Plasma Pharmacokinetics: Terminal Elimination Rate Constant (λz) of AGN-241622 | To evaluate the systemic and local pharmacokinetics of AGN-241622 administered once unilaterally in healthy participants | Not Posted | Day 1 | Participants |
| Secondary | Stage 1 Plasma Pharmacokinetics: Maximum Plasma Concentrations (Cmax) of AGN-241622 | To evaluate the systemic and local pharmacokinetics of AGN-241622 administered once unilaterally in healthy participants | Not Posted | Day 1 | Participants |
| Secondary | Stage 1 Plasma Pharmacokinetics: Time of Maximum Plasma Concentrations (Tmax) of AGN-241622 | To evaluate the systemic and local pharmacokinetics of AGN-241622 administered once unilaterally in healthy participants | Not Posted | Day 1 | Participants |
| Secondary | Stage 1 Plasma Pharmacokinetics: Apparent Total Clearance of AGN-241622 From Plasma (CL/F) | To evaluate the systemic and local pharmacokinetics of AGN-241622 administered once unilaterally in healthy participants | Not Posted | Day 1 | Participants |
| Secondary | Stage 1 Plasma Pharmacokinetics: Volume of Distribution During the Terminal Elimination Phase (Vz/F) of AGN-241622 | To evaluate the systemic and local pharmacokinetics of AGN-241622 administered once unilaterally in healthy participants | Not Posted | Day 1 | Participants |
| Secondary | Stage 1 Plasma Pharmacokinetics: Area Under the Concentration-time Curve From Time 0 to Time t (AUC0-t) of AGN-241622 | To evaluate the systemic and local pharmacokinetics of AGN-241622 administered once unilaterally in healthy participants | Not Posted | Day 1 | Participants |
| Secondary | Stage 1 Plasma Pharmacokinetics: Area Under the Concentration-time Curve From Time 0 to Infinity (AUC0-inf) of AGN-241622 | To evaluate the systemic and local pharmacokinetics of AGN-241622 administered once unilaterally in healthy participants | Not Posted | Day 1 | Participants |
| Secondary | Stage 1 Tears Pharmacokinetics: Area Under the Concentration-time Curve From Time 0 to Time t (AUC0-t) of AGN-241622 | To evaluate the systemic and local pharmacokinetics of AGN-241622 administered once unilaterally in healthy participants | Not Posted | Day 1 | Participants |
| Secondary | Stage 1 Tears Pharmacokinetics: Area Under the Concentration-time Curve From Time 0 to Infinity (AUC0-inf) of AGN-241622 | To evaluate the systemic and local pharmacokinetics of AGN-241622 administered once unilaterally in healthy participants | Not Posted | Day 1 | Participants |
| Secondary | Stage 1 Tears Pharmacokinetics: Maximum Plasma Concentrations (Cmax) of AGN-241622 | To evaluate the systemic and local pharmacokinetics of AGN-241622 administered once unilaterally in healthy participants | Not Posted | Day 1 | Participants |
| Secondary | Stage 1 Tears Pharmacokinetics: Time of Maximum Plasma Concentrations (Tmax) of AGN-241622 | To evaluate the systemic and local pharmacokinetics of AGN-241622 administered once unilaterally in healthy participants | Not Posted | Day 1 | Participants |
| Secondary | Stage 1 Tears Pharmacokinetics: Terminal Elimination Rate Constant (λz) of AGN-241622 | To evaluate the systemic and local pharmacokinetics of AGN-241622 administered once unilaterally in healthy participants | Not Posted | Day 1 | Participants |
| Secondary | Stage 1 Tears Pharmacokinetics: Terminal Elimination Half-life (T1/2) of AGN-241622 | To evaluate the systemic and local pharmacokinetics of AGN-241622 administered once unilaterally in healthy participants | Not Posted | Day 1 | Participants |
| Secondary | Stage 1: Pupil Diameter Measurement | To evaluate the target receptor engagement of AGN-241622 as compared with vehicle administered once, unilaterally in healthy participants | Not Posted | Day 1 | Participants |
| Secondary | Stage 2a Plasma Pharmacokinetics: Area Under the Concentration-time Curve From Time 0 to Time t (AUC0-t) of AGN-241622 | To evaluate the systemic and local pharmacokinetics of AGN-241622 after repeat bilateral administration in participants with presbyopia | Not Posted | 14 Days | Participants |
| Secondary | Stage 2a Plasma Pharmacokinetics: Area Under the Plasma/Tear Concentration Versus Time Curve From Time 0 to the End of the Dosing Period (AUC0-tau) of AGN-241622 | To evaluate the systemic and local pharmacokinetics of AGN-241622 after repeat bilateral administration in participants with presbyopia | Not Posted | 14 Days | Participants |
| Secondary | Stage 2a Plasma Pharmacokinetics: Maximum Plasma Concentrations (Cmax) of AGN-241622 | To evaluate the systemic and local pharmacokinetics of AGN-241622 after repeat bilateral administration in participants with presbyopia | Not Posted | 14 Days | Participants |
| Secondary | Stage 2a Plasma Pharmacokinetics: Minimum Plasma Concentrations (Cmin) of AGN-241622 | To evaluate the systemic and local pharmacokinetics of AGN-241622 after repeat bilateral administration in participants with presbyopia | Not Posted | 14 Days | Participants |
| Secondary | Stage 2a Plasma Pharmacokinetics: Time of Maximum Plasma Concentrations (Tmax) of AGN-241622 | To evaluate the systemic and local pharmacokinetics of AGN-241622 after repeat bilateral administration in participants with presbyopia | Not Posted | 14 Days | Participants |
| Secondary | Stage 2a Plasma Pharmacokinetics: Terminal Elimination Rate Constant (λz) of AGN-241622 | To evaluate the systemic and local pharmacokinetics of AGN-241622 after repeat bilateral administration in participants with presbyopia | Not Posted | 14 Days | Participants |
| Secondary | Stage 2a Plasma Pharmacokinetics: Terminal Elimination Half-life (T1/2) of AGN-241622 | To evaluate the systemic and local pharmacokinetics of AGN-241622 after repeat bilateral administration in participants with presbyopia | Not Posted | 14 Days | Participants |
| Secondary | Stage 2a Plasma Pharmacokinetics: Apparent Total Clearance of AGN-241622 From Plasma (CL/F) | To evaluate the systemic and local pharmacokinetics of AGN-241622 after repeat bilateral administration in participants with presbyopia | Not Posted | 14 Days | Participants |
| Secondary | Stage 2a Plasma Pharmacokinetics: Volume of Distribution During the Terminal Elimination Phase (Vz/F) of AGN-241622 | To evaluate the systemic and local pharmacokinetics of AGN-241622 after repeat bilateral administration in participants with presbyopia | Not Posted | 14 Days | Participants |
| Secondary | Stage 2a Plasma Pharmacokinetics: Accumulation Ratio of AGN-241622 | To evaluate the systemic and local pharmacokinetics of AGN-241622 after repeat bilateral administration in participants with presbyopia | Not Posted | 14 Days | Participants |
| Secondary | Stage 2a Tears Pharmacokinetics: Area Under the Concentration-time Curve From Time 0 to Time t (AUC0-t) of AGN-241622 | To evaluate the systemic and local pharmacokinetics of AGN-241622 after repeat bilateral administration in participants with presbyopia | Not Posted | 14 Days | Participants |
| Secondary | Stage 2a Tears Pharmacokinetics: Area Under the Plasma/Tear Concentration Versus Time Curve From Time 0 to the End of the Dosing Period (AUC0-tau) of AGN-241622 | To evaluate the systemic and local pharmacokinetics of AGN-241622 after repeat bilateral administration in participants with presbyopia | Not Posted | 14 Days | Participants |
| Secondary | Stage 2a Tears Pharmacokinetics: Maximum Plasma Concentrations (Cmax) of AGN-241622 | To evaluate the systemic and local pharmacokinetics of AGN-241622 after repeat bilateral administration in participants with presbyopia | Not Posted | 14 Days | Participants |
| Secondary | Stage 2a Tears Pharmacokinetics: Time of Maximum Plasma Concentrations (Tmax) of AGN-241622 | To evaluate the systemic and local pharmacokinetics of AGN-241622 after repeat bilateral administration in participants with presbyopia | Not Posted | 14 Days | Participants |
| Secondary | Stage 2a Tears Pharmacokinetics: Terminal Elimination Rate Constant (λz) of AGN-241622 | To evaluate the systemic and local pharmacokinetics of AGN-241622 after repeat bilateral administration in participants with presbyopia | Not Posted | 14 Days | Participants |
| Secondary | Stage 2a Tears Pharmacokinetics: Terminal Elimination Half-life (T1/2) of AGN-241622 | To evaluate the systemic and local pharmacokinetics of AGN-241622 after repeat bilateral administration in participants with presbyopia | Not Posted | 14 Days | Participants |
| 0 |
| 9 |
| 0 |
| 9 |
| 3 |
| 9 |
| EG001 | Cohort 1: AGN-241622 Dose 1 | Administered as single drop in one eye AGN-241622: Topical eye drop | 0 | 8 | 0 | 8 | 7 | 8 |
| EG002 | Cohort 2: AGN-241622 Dose 2 | Administered as single drop in one eye AGN-241622: Topical eye drop | 0 | 9 | 0 | 9 | 4 | 9 |
| EG003 | Cohort 3: AGN-241622 Dose 3 | Administered as single drop in one eye AGN-241622: Topical eye drop | 0 | 9 | 0 | 9 | 0 | 9 |
| EG004 | Stage 2a Placebo Dose | Administered as single drop in each eye Vehicle: Topical eye drop | 0 | 9 | 0 | 9 | 1 | 9 |
| EG005 | Cohort 4: AGN-241622 Dose 1 | Administered as a single drop in each eye AGN-241622: Topical eye drop | 0 | 12 | 0 | 12 | 0 | 12 |
| EG006 | Cohort 5: AGN-241622 Dose 2 | Administered as a single drop in each eye AGN-241622: Topical eye drop | 0 | 11 | 0 | 11 | 3 | 11 |
| EG007 | Cohort 6: AGN-241622 Dose 3 | Administered as a single drop in each eye AGN-241622: Topical eye drop | 0 | 10 | 0 | 10 | 2 | 10 |
| EYE IRRITATION | Eye disorders | MedDRA 26.0 | Systematic Assessment |
|
| EYE PRURITUS | Eye disorders | MedDRA 26.0 | Systematic Assessment |
|
| LACRIMATION INCREASED | Eye disorders | MedDRA 26.0 | Systematic Assessment |
|
| PHOTOPHOBIA | Eye disorders | MedDRA 26.0 | Systematic Assessment |
|
| PUNCTATE KERATITIS | Eye disorders | MedDRA 26.0 | Systematic Assessment |
|
| VISION BLURRED | Eye disorders | MedDRA 26.0 | Systematic Assessment |
|
| BLOOD BILIRUBIN INCREASED | Investigations | MedDRA 26.0 | Systematic Assessment |
|
| BLOOD GLUCOSE DECREASED | Investigations | MedDRA 26.0 | Systematic Assessment |
|
| BLOOD GLUCOSE INCREASED | Investigations | MedDRA 26.0 | Systematic Assessment |
|
| BLOOD PRESSURE DIASTOLIC INCREASED | Investigations | MedDRA 26.0 | Systematic Assessment |
|
| PROTEIN URINE PRESENT | Investigations | MedDRA 26.0 | Systematic Assessment |
|
| HEADACHE | Nervous system disorders | MedDRA 26.0 | Systematic Assessment |
|
| DERMATITIS | Skin and subcutaneous tissue disorders | MedDRA 26.0 | Systematic Assessment |
|
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.
| Non-ocular |
|