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This is a safety, efficacy and pharmacokinetics study of the fixed combination of AGN-199201 and AGN-190584 in participants with presbyopia (inability to focus on items close-up).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1: Vehicle Control | Experimental | Vehicle dosed in both eyes administered once daily during office visits 1 through 5. |
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| Cohort 2: AGN-199201 Dose A and AGN-190584 Dose A | Experimental | Fixed combinations of AGN-199201 Dose A and AGN-190584 Dose A dosed in both eyes administered once daily during office visits 1 through 5. |
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| Cohort 3: AGN-199201 Dose B and AGN-190584 Dose B | Experimental | Fixed combinations of AGN-199201 Dose B and AGN-190584 Dose B dosed in both eyes administered once daily during office visits 1 through 5. |
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| Cohort 4: AGN-199201 Dose C and AGN-190584 Dose C | Experimental | Fixed combinations of AGN-199201 Dose C and AGN-190584 Dose C dosed in both eyes administered once daily during office visits 1 through 5. |
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| Cohort 5: Vehicle, AGN-199201 Dose C and AGN-190584 Dose C | Experimental |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AGN-199201 ophthalmic solution | Drug | 1 drop of AGN-199201 ophthalmic solution Doses A, B, C in the eye. |
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| Measure | Description | Time Frame |
|---|---|---|
| Weighted Average Change From Baseline in Uncorrected Near Visual Acuity (UNVA) Letters in the Nondominant Eye | UNVA is assessed without corrective lenses in the non-dominant eye. UNVA is measured using an eye chart and is reported as the number of lines read correctly. The lower the number of lines read correctly on the eye chart, the worse the vision (or visual acuity). An increase in the number of lines read correctly means that vision has improved. | Baseline, Day 28 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Experiencing One or More Treatment Emergent Adverse Events (TEAEs) | A Treatment Emergent Adverse Event was considered any unfavorable and unintended sign, symptom, or disease associated with the use of the study drug, whether or not considered related to the study drug. An Adverse Drug Reaction was a harmful and unintended reaction that is incurred during routine administration or use of the drug, whose causal relationship with the drug cannot be excluded. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Haixia Liu | Allergan | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Retina Institute of California Medical Group | Arcadia | California | 91007 | United States | ||
| Sall Research Medical Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34855038 | Derived | Shirneshan E, Coon CD, Johnson N, Stokes J, Wells T, Lundy JJ, Andrae DA, Evans CJ, Campbell J. Development of the Near Vision Presbyopia Task-based Questionnaire for use in evaluating the impact of presbyopia. J Patient Rep Outcomes. 2021 Dec 2;5(1):125. doi: 10.1186/s41687-021-00378-y. | |
| 34643894 | Derived |
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Randomization and treatment assignment were based on a randomization scheme prepared by Allergan Biostatistics prior to the start of the study.
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| ID | Title | Description |
|---|---|---|
| FG000 | Cohort 1: Vehicle Control | Vehicle dosed in both eyes administered once daily during office visits 1 through 5. |
| FG001 | Cohort 2: AGN-199201 Lower Dose and AGN-190584 Lower Dose |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| SAP | No | Yes | No | Statistical Analysis Plan | Dec 15, 2017 | Oct 16, 2020 |
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Dominant eye dosed with Vehicle. Fixed combinations of AGN-199201 Dose C and AGN-190584 Dose C dosed in nondominant eye. Treatment administered once daily during office visits 1 through 5.
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| AGN-190584 ophthalmic solution | Drug | 1 drop of AGN-190584 ophthalmic solution Doses A, B, C in the eye. |
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| AGN-199201 Vehicle | Drug | Vehicle to AGN-199201 |
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| AGN-190584 Vehicle | Drug | Vehicle to AGN-190584 |
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| up to 65 days |
| Artesia |
| California |
| 90701 |
| United States |
| WCCT Global, LLC | Cypress | California | 90630 | United States |
| Specialty Eye Care Medical Center | Glendale | California | 91203 | United States |
| Lugene Eye Institute | Glendale | California | 91204 | United States |
| The Eye Research Foundation | Newport Beach | California | 92663 | United States |
| Stanford Eye and Laser Center | Palo Alto | California | 94303 | United States |
| Wolstan and Golberg Eye Associates | Torrance | California | 90505 | United States |
| MedEye Associates | Miami | Florida | 33143 | United States |
| Central Florida Eye Institute | Ocala | Florida | 34474 | United States |
| Center for Sight | Sarasota | Florida | 34239 | United States |
| Clayton Eye Center | Morrow | Georgia | 30260 | United States |
| Silverstein Eye Centers | Louisville | Kentucky | 40206 | United States |
| The Eye Care Institute | Louisville | Kentucky | 40206 | United States |
| Specialized Eye Care | Baltimore | Maryland | 21210 | United States |
| James D. Branch | Winston-Salem | North Carolina | 27101 | United States |
| Devers Eye Institute | Portland | Oregon | 97210 | United States |
| Scott & Christie and Associates, PC | Cranberry Township | Pennsylvania | 16066 | United States |
| Medical University of South Carolina | Charleston | South Carolina | 29425 | United States |
| Total Eye Care, PA | Memphis | Tennessee | 38119 | United States |
| Cataract and Glaucoma Center | El Paso | Texas | 79902 | United States |
| University of Texas Medical Branch | Galveston | Texas | 77555 | United States |
| R and R Eye Research, LLC | San Antonio | Texas | 78229 | United States |
| Medical Center Ophthalmology Associates | San Antonio | Texas | 78240 | United States |
| Hoopes Durrie Rivera Research, LLC | Draper | Utah | 84020 | United States |
| Johnson N, Shirneshan E, Coon CD, Stokes J, Wells T, Lundy JJ, Andrae DA, Evans CJ, Campbell J. Development of the Presbyopia Impact and Coping Questionnaire. Ophthalmol Ther. 2021 Dec;10(4):1057-1075. doi: 10.1007/s40123-021-00391-w. Epub 2021 Oct 13. |
Fixed combinations of AGN-199201 Lower Dose and AGN-190584 Lower Dose dosed in both eyes administered once daily during office visits 1 through 5.
| FG002 | Cohort 3: AGN-199201 Medium Dose and AGN-190584 Medium Dose | Fixed combinations of AGN-199201 Medium Dose and AGN-190584 Medium Dose dosed in both eyes administered once daily during office visits 1 through 5. |
| FG003 | Cohort 4: AGN-199201 Higher Dose and AGN-190584 Higher Dose | Fixed combinations of AGN-199201 Higher Dose and AGN-190584 Higher Dose dosed in both eyes administered once daily during office visits 1 through 5. |
| FG004 | Cohort 5: Vehicle, AGN-199201 Higher Dose and AGN-190584 Higher Dose | Dominant eye dosed with Vehicle. Fixed combinations of AGN-199201 Higher Dose and AGN-190584 Higher Dose dosed in nondominant eye. Treatment administered once daily during office visits 1 through 5. |
| COMPLETED |
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| NOT COMPLETED |
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Safety population: All patients who received ≥ 1 administration of study treatment
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| ID | Title | Description |
|---|---|---|
| BG000 | Cohort 1: Vehicle Control | Vehicle dosed in both eyes administered once daily during office visits 1 through 5. |
| BG001 | Cohort 2: AGN-199201 Lower Dose and AGN-190584 Lower Dose | Fixed combinations of AGN-199201 Lower Dose and AGN-190584 Lower Dose dosed in both eyes administered once daily during office visits 1 through 5. |
| BG002 | Cohort 3: AGN-199201 Medium Dose and AGN-190584 Medium Dose | Fixed combinations of AGN-199201 Medium Dose and AGN-190584 Medium Dose dosed in both eyes administered once daily during office visits 1 through 5. |
| BG003 | Cohort 4: AGN-199201 Higher Dose and AGN-190584 Higher Dose | Fixed combinations of AGN-199201 Higher Dose and AGN-190584 Higher Dose dosed in both eyes administered once daily during office visits 1 through 5. |
| BG004 | Cohort 5: Vehicle, AGN-199201 Higher Dose and AGN-190584 Higher Dose | Dominant eye dosed with Vehicle. Fixed combinations of AGN-199201 Higher Dose and AGN-190584 Higher Dose dosed in nondominant eye. Treatment administered once daily during office visits 1 through 5. |
| BG005 | Total | Total of all reporting groups |
| 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, Continuous | Median | 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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| Baseline UNVA severity | Baseline UNVA measured visual acuity using Snellen Scores. Worse "severity" meant poorer visual acuity as measured by baseline UNVA (uncorrected near visual acuity). This graded measure was used to stratify participants into two groups: UNVA at baseline (≤ 20/80 and > 20/80). | Count of Participants | Participants |
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| 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 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Primary | Weighted Average Change From Baseline in Uncorrected Near Visual Acuity (UNVA) Letters in the Nondominant Eye | UNVA is assessed without corrective lenses in the non-dominant eye. UNVA is measured using an eye chart and is reported as the number of lines read correctly. The lower the number of lines read correctly on the eye chart, the worse the vision (or visual acuity). An increase in the number of lines read correctly means that vision has improved. | Modified Intent-to-Treat (mITT) population: all randomized patients who were randomized with a baseline and at least 1 post baseline assessment of mesopic, high contrast, UNVA. | Posted | Least Squares Mean | Standard Error | letters correctly read | Baseline, Day 28 |
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| Secondary | Number of Participants Experiencing One or More Treatment Emergent Adverse Events (TEAEs) | A Treatment Emergent Adverse Event was considered any unfavorable and unintended sign, symptom, or disease associated with the use of the study drug, whether or not considered related to the study drug. An Adverse Drug Reaction was a harmful and unintended reaction that is incurred during routine administration or use of the drug, whose causal relationship with the drug cannot be excluded. | Modified Intent-to-Treat (mITT) population: all randomized patients who were randomized with a baseline and at least 1 post baseline assessment of mesopic, high contrast, UNVA. | Posted | Count of Participants | Participants | up to 65 days |
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Adverse Events were collected for up to 65 days.
Safety population: All patients who received ≥ 1 administration of study treatment
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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 | Cohort 1: Vehicle Control | Vehicle dosed in both eyes administered once daily during office visits 1 through 5. | 0 | 28 | 0 | 28 | 7 | 28 |
| EG001 | Cohort 2: AGN-199201 Lower Dose and AGN-190584 Lower Dose | Fixed combinations of AGN-199201 Lower Dose and AGN-190584 Lower Dose dosed in both eyes administered once daily during office visits 1 through 5. | 0 | 30 | 0 | 30 | 8 | 30 |
| EG002 | Cohort 3: AGN-199201 Medium Dose and AGN-190584 Medium Dose | Fixed combinations of AGN-199201 Medium Dose and AGN-190584 Medium Dose dosed in both eyes administered once daily during office visits 1 through 5. | 0 | 30 | 0 | 30 | 10 | 30 |
| EG003 | Cohort 4: AGN-199201 Higher Dose and AGN-190584 Higher Dose | Fixed combinations of AGN-199201 Higher Dose and AGN-190584 Higher Dose dosed in both eyes administered once daily during office visits 1 through 5. | 0 | 32 | 0 | 32 | 11 | 32 |
| EG004 | Cohort 5: Vehicle, AGN-199201 Higher Dose and AGN-190584 Higher Dose | Dominant eye dosed with Vehicle. Fixed combinations of AGN-199201 Higher Dose and AGN-190584 Higher Dose dosed in nondominant eye. Treatment administered once daily during office visits 1 through 5. | 0 | 31 | 0 | 31 | 7 | 31 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Vision blurred | Eye disorders | MedDRA Version 20.0 | Systematic Assessment |
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| Instillation site pruritus | General disorders | MedDRA Version 20.0 | Systematic Assessment |
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| Instillation site foreign body sensation | General disorders | MedDRA Version 20.0 | Systematic Assessment |
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| Instillation site pain | General disorders | MedDRA Version 20.0 | Systematic Assessment |
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| Instillation site lacrimation | General disorders | MedDRA Version 20.0 | Systematic Assessment |
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| Upper respiratory tract infection | Infections and infestations | MedDRA Version 20.0 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA Version 20.0 | Systematic Assessment |
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A disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 90 days from the time submitted to the sponsor for review. The sponsor cannot require changes to the communication and cannot extend the embargo
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Therapeutic Area Head | Allergan | 714-246-4500 | IR-CTRegistration@allergan.com |
| SAP_000.pdf |
| Prot | Yes | No | No | Study Protocol | Aug 18, 2016 | Oct 16, 2020 | Prot_001.pdf |
| ID | Term |
|---|---|
| D011305 | Presbyopia |
| ID | Term |
|---|---|
| D012030 | Refractive Errors |
| D005128 | Eye Diseases |
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| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| > 20/80 |
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| 4.77 |
| 2-Sided |
| 95 |
| 1.98 |
| 7.56 |
| Superiority |
| ANCOVA | 0.0014 | LS Mean Diff | 4.54 | 2-Sided | 95 | 1.79 | 7.29 | Superiority |
| ANCOVA | 0.0008 | LS Mean Diff | 4.81 | 2-Sided | 95 | 2.03 | 7.58 | Superiority |
| OG003 | Cohort 4: AGN-199201 Higher Dose and AGN-190584 Higher Dose | Fixed combinations of AGN-199201 Higher Dose and AGN-190584 Higher Dose dosed in both eyes administered once daily during office visits 1 through 5. |
| OG004 | Cohort 5: Vehicle, AGN-199201 Higher Dose and AGN-190584 Higher Dose | Dominant eye dosed with Vehicle. Fixed combinations of AGN-199201 Higher Dose and AGN-190584 Higher Dose dosed in nondominant eye. Treatment administered once daily during office visits 1 through 5. |
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