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This study will identify the optimum concentrations of AGN-199201 and AGN-190584 when dosed in combination once a day for the improvement of uncorrected near visual acuity in participants with presbyopia (inability to focus on items close-up).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AGN-199201 and AGN-190584 Vehicle | Experimental | Participants will receive 5 different treatments as per protocol for 2 days each. Treatment 1: nondominant eye--1 drop AGN-199201 vehicle followed by 1 drop AGN-190584 vehicle, dominant eye--2 drops AGN-190584 vehicle; Treatment 2: nondominant eye--1 drop AGN-199201 Dose A followed by 1 drop AGN-190584 vehicle, dominant eye--2 drops AGN-190584 vehicle; Treatment 3: nondominant eye--1 drop AGN-199201 Dose B followed by 1 drop AGN-190584 vehicle, dominant eye--2 drops AGN-190584 vehicle; Treatment 4: nondominant eye--1 drop AGN-199201 Dose C followed by 1 drop AGN-190584 vehicle, dominant eye--2 drops AGN-190584 vehicle; Treatment 5: nondominant eye--1 drop fixed combination of AGN-199201 and AGN-190584 followed by 1 drop AGN-190584 vehicle, dominant eye--2 drops AGN-190584 vehicle. |
|
| AGN-199201 and AGN-190584 Dose A | Experimental | Participants will receive 5 different treatments as per protocol for 2 days each. Treatment 1: nondominant eye--1 drop AGN-199201 vehicle followed by 1 drop AGN-190584 Dose A, dominant eye--2 drops AGN-190584 vehicle; Treatment 2: nondominant eye--1 drop AGN-199201 Dose A followed by 1 drop AGN-190584 Dose A, dominant eye--2 drops AGN-190584 vehicle; Treatment 3: nondominant eye--1 drop AGN-199201 Dose B followed by 1 drop AGN-190584 Dose A, dominant eye--2 drops AGN-190584 vehicle; Treatment 4: nondominant eye--1 drop AGN-199201 Dose C followed by 1 drop AGN-190584 Dose A, dominant eye--2 drops AGN-190584 vehicle; Treatment 5: nondominant eye--1 drop fixed combination of AGN-199201 and AGN-190584 followed by 1 drop AGN-190584 vehicle, dominant eye--2 drops AGN-190584 vehicle. |
|
| 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. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Weighted Average Change From Baseline in Mesopic, High Contrast Uncorrected Near Visual Acuity (UNVA) Letters | 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, Between hour 1 and hour 10 of each of the five 2-day dosing periods |
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Inclusion Criteria:
-Normal vision at distance, either natural or post corneal laser refractive surgery, with presbyopia in each eye and complaints of poor near vision that impacts activities of daily living.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Haixia Liu | Allergan | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sall Research Medical Center | Artesia | California | 90701 | United States | ||
| Milton M. Hom, OD, FAAO |
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 | AGN-190584 Vehicle and AGN-199201 | Participants will receive 5 different treatments as per protocol for 2 days each. Treatment 1: nondominant eye--1 drop AGN-199201 vehicle followed by 1 drop AGN-190584 vehicle, dominant eye--2 drops AGN-190584 vehicle; Treatment 2: nondominant eye--1 drop AGN-199201 Lower Dose followed by 1 drop AGN-190584 vehicle, dominant eye--2 drops AGN-190584 vehicle; Treatment 3: nondominant eye--1 drop AGN-199201 Medium Dose followed by 1 drop AGN-190584 vehicle, dominant eye--2 drops AGN-190584 vehicle; Treatment 4: nondominant eye--1 drop AGN-199201 Higher Dose followed by 1 drop AGN-190584 vehicle, dominant eye--2 drops AGN-190584 vehicle; Treatment 5: nondominant eye--1 drop fixed combination of AGN-199201 and AGN-190584 followed by 1 drop AGN-190584 vehicle, dominant eye--2 drops AGN-190584 vehicle. |
| 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 | Nov 9, 2017 | Oct 16, 2020 |
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| AGN-199201 and AGN-190584 Dose B | Experimental | Participants will receive 5 different treatments as per protocol for 2 days each. Treatment 1: nondominant eye--1 drop AGN-199201 vehicle followed by 1 drop AGN-190584 Dose B, dominant eye--2 drops AGN-190584 vehicle; Treatment 2: nondominant eye--1 drop AGN-199201 Dose A followed by 1 drop AGN-190584 Dose B, dominant eye--2 drops AGN-190584 vehicle; Treatment 3: nondominant eye--1 drop AGN-199201 Dose B followed by 1 drop AGN-190584 Dose B, dominant eye--2 drops AGN-190584 vehicle; Treatment 4: nondominant eye--1 drop AGN-199201 Dose C followed by 1 drop AGN-190584 Dose B, dominant eye--2 drops AGN-190584 vehicle; Treatment 5: nondominant eye--1 drop fixed combination of AGN-199201 and AGN-190584 followed by 1 drop AGN-190584 vehicle, dominant eye--2 drops AGN-190584 vehicle. |
|
| AGN-199201 and AGN-190584 Dose C | Experimental | Participants will receive 5 different treatments as per protocol for 2 days each. Treatment 1: nondominant eye--1 drop AGN-199201 vehicle followed by 1 drop AGN-190584 Dose C, dominant eye--2 drops AGN-190584 vehicle; Treatment 2: nondominant eye--1 drop AGN-199201 Dose A followed by 1 drop AGN-190584 Dose C, dominant eye--2 drops AGN-190584 vehicle; Treatment 3: nondominant eye--1 drop AGN-199201 Dose B followed by 1 drop AGN-190584 Dose C, dominant eye--2 drops AGN-190584 vehicle; Treatment 4: nondominant eye--1 drop AGN-199201 Dose C followed by 1 drop AGN-190584 Dose C, dominant eye--2 drops AGN-190584 vehicle; Treatment 5: nondominant eye--1 drop fixed combination of AGN-199201 and AGN-190584 followed by 1 drop AGN-190584 vehicle, dominant eye--2 drops AGN-190584 vehicle. |
|
| AGN-190584 ophthalmic solution | Drug | 1 drop AGN-190584 ophthalmic solution doses A, B and C in the eye. |
|
| AGN-190584 vehicle | Drug | Vehicle to AGN-190584 |
|
| AGN-199201 + AGN-190584 Combination | Drug | 1 drop AGN-199201 and AGN-190584 fixed combination ophthalmic solution in the eye. |
|
| AGN-199201 vehicle | Drug | Vehicle to AGN-199201 |
|
| Azusa |
| California |
| 91702 |
| United States |
| WCCT Global, LLC | Costa Mesa | California | 92626 | United States |
| The Eye Research Foundation | Newport Beach | California | 92663 | United States |
| North Bay Eye Associates, Inc. | Petaluma | California | 94954 | United States |
| Martel Eye Medical Group | Rancho Cordova | California | 95670 | United States |
| West Coast Eye Care | San Diego | California | 92115 | United States |
| Corneal Consultants of Colorado, P.C. | Littleton | Colorado | 80120 | United States |
| Mid Florida Eye Center | Mt. Dora | Florida | 32757 | United States |
| Clayton Eye Center | Morrow | Georgia | 30260 | United States |
| Price Vision Group | Indianapolis | Indiana | 46260 | United States |
| Specialized Eye Care | Baltimore | Maryland | 21210 | United States |
| Comprehensive Eye Care, Ltd | Washington | Missouri | 63090 | United States |
| Cleveland Eye Clinic | Brecksville | Ohio | 44141 | United States |
| Scott & Christie and Associates, PC | Cranberry Township | Pennsylvania | 16066 | United States |
| Total Eye Care, PA | Memphis | Tennessee | 38119 | United States |
| Cataract and Glaucoma Center | El Paso | Texas | 79902 | United States |
| Medical Center Ophthalmology Associates | San Antonio | Texas | 78240 | United States |
| Hoopes Durrie Rivera Research, LLC | Draper | Utah | 84020 | United States |
| The Eye Centers of Racine & Kenosha | Kenosha | Wisconsin | 53142 | United States |
| FG001 | AGN-190584 Lower Dose and AGN-199201 | Participants will receive 5 different treatments as per protocol for 2 days each. Treatment 1: nondominant eye--1 drop AGN-199201 vehicle followed by 1 drop AGN-190584 Lower Dose, dominant eye--2 drops AGN-190584 vehicle; Treatment 2: nondominant eye--1 drop AGN-199201 Lower Dose followed by 1 drop AGN-190584 Lower Dose, dominant eye--2 drops AGN-190584 vehicle; Treatment 3: nondominant eye--1 drop AGN-199201 Medium Dose followed by 1 drop AGN-190584 Lower Dose, dominant eye--2 drops AGN-190584 vehicle; Treatment 4: nondominant eye--1 drop AGN-199201 Higher Dose followed by 1 drop AGN-190584 Lower Dose, dominant eye--2 drops AGN-190584 vehicle; Treatment 5: nondominant eye--1 drop fixed combination of AGN-199201 and AGN-190584 followed by 1 drop AGN-190584 vehicle, dominant eye--2 drops AGN-190584 vehicle. |
| FG002 | AGN-190584 Medium Dose and AGN-199201 | Participants will receive 5 different treatments as per protocol for 2 days each. Treatment 1: nondominant eye--1 drop AGN-199201 vehicle followed by 1 drop AGN-190584 Medium Dose, dominant eye--2 drops AGN-190584 vehicle; Treatment 2: nondominant eye--1 drop AGN-199201 Lower Dose followed by 1 drop AGN-190584 Medium Dose, dominant eye--2 drops AGN-190584 vehicle; Treatment 3: nondominant eye--1 drop AGN-199201 Medium Dose followed by 1 drop AGN-190584 Medium Dose, dominant eye--2 drops AGN-190584 vehicle; Treatment 4: nondominant eye--1 drop AGN-199201 Higher Dose followed by 1 drop AGN-190584 Medium Dose, dominant eye--2 drops AGN-190584 vehicle; Treatment 5: nondominant eye--1 drop fixed combination of AGN-199201 and AGN-190584 followed by 1 drop AGN-190584 vehicle, dominant eye--2 drops AGN-190584 vehicle. |
| FG003 | AGN-190584 Higher Dose and AGN-199201 | Participants will receive 5 different treatments as per protocol for 2 days each. Treatment 1: nondominant eye--1 drop AGN-199201 vehicle followed by 1 drop AGN-190584 Higher Dose, dominant eye--2 drops AGN-190584 vehicle; Treatment 2: nondominant eye--1 drop AGN-199201 Lower Dose followed by 1 drop AGN-190584 Higher Dose, dominant eye--2 drops AGN-190584 vehicle; Treatment 3: nondominant eye--1 drop AGN-199201 Medium Dose followed by 1 drop AGN-190584 Higher Dose, dominant eye--2 drops AGN-190584 vehicle; Treatment 4: nondominant eye--1 drop AGN-199201 Higher Dose followed by 1 drop AGN-190584 Higher Dose, dominant eye--2 drops AGN-190584 vehicle; Treatment 5: nondominant eye--1 drop fixed combination of AGN-199201 and AGN-190584 followed by 1 drop AGN-190584 vehicle, dominant eye--2 drops AGN-190584 vehicle. |
| COMPLETED |
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| NOT COMPLETED |
|
|
Safety Population: all subjects who received ≥ 1 administration of study treatment
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| ID | Title | Description |
|---|---|---|
| BG000 | AGN-190584 Vehicle and AGN-199201 | Participants will receive 5 different treatments as per protocol for 2 days each. Treatment 1: nondominant eye--1 drop AGN-199201 vehicle followed by 1 drop AGN-190584 vehicle, dominant eye--2 drops AGN-190584 vehicle; Treatment 2: nondominant eye--1 drop AGN-199201 Lower Dose followed by 1 drop AGN-190584 vehicle, dominant eye--2 drops AGN-190584 vehicle; Treatment 3: nondominant eye--1 drop AGN-199201 Medium Dose followed by 1 drop AGN-190584 vehicle, dominant eye--2 drops AGN-190584 vehicle; Treatment 4: nondominant eye--1 drop AGN-199201 Higher Dose followed by 1 drop AGN-190584 vehicle, dominant eye--2 drops AGN-190584 vehicle; Treatment 5: nondominant eye--1 drop fixed combination of AGN-199201 and AGN-190584 followed by 1 drop AGN-190584 vehicle, dominant eye--2 drops AGN-190584 vehicle. |
| BG001 | AGN-190584 Lower Dose and AGN-199201 | Participants will receive 5 different treatments as per protocol for 2 days each. Treatment 1: nondominant eye--1 drop AGN-199201 vehicle followed by 1 drop AGN-190584 Lower Dose, dominant eye--2 drops AGN-190584 vehicle; Treatment 2: nondominant eye--1 drop AGN-199201 Lower Dose followed by 1 drop AGN-190584 Lower Dose, dominant eye--2 drops AGN-190584 vehicle; Treatment 3: nondominant eye--1 drop AGN-199201 Medium Dose followed by 1 drop AGN-190584 Lower Dose, dominant eye--2 drops AGN-190584 vehicle; Treatment 4: nondominant eye--1 drop AGN-199201 Higher Dose followed by 1 drop AGN-190584 Lower Dose, dominant eye--2 drops AGN-190584 vehicle; Treatment 5: nondominant eye--1 drop fixed combination of AGN-199201 and AGN-190584 followed by 1 drop AGN-190584 vehicle, dominant eye--2 drops AGN-190584 vehicle. |
| BG002 | AGN-190584 Medium Dose and AGN-199201 | Participants will receive 5 different treatments as per protocol for 2 days each. Treatment 1: nondominant eye--1 drop AGN-199201 vehicle followed by 1 drop AGN-190584 Medium Dose, dominant eye--2 drops AGN-190584 vehicle; Treatment 2: nondominant eye--1 drop AGN-199201 Lower Dose followed by 1 drop AGN-190584 Medium Dose, dominant eye--2 drops AGN-190584 vehicle; Treatment 3: nondominant eye--1 drop AGN-199201 Medium Dose followed by 1 drop AGN-190584 Medium Dose, dominant eye--2 drops AGN-190584 vehicle; Treatment 4: nondominant eye--1 drop AGN-199201 Higher Dose followed by 1 drop AGN-190584 Medium Dose, dominant eye--2 drops AGN-190584 vehicle; Treatment 5: nondominant eye--1 drop fixed combination of AGN-199201 and AGN-190584 followed by 1 drop AGN-190584 vehicle, dominant eye--2 drops AGN-190584 vehicle. |
| BG003 | AGN-190584 Higher Dose and AGN-199201 | Participants will receive 5 different treatments as per protocol for 2 days each. Treatment 1: nondominant eye--1 drop AGN-199201 vehicle followed by 1 drop AGN-190584 Higher Dose, dominant eye--2 drops AGN-190584 vehicle; Treatment 2: nondominant eye--1 drop AGN-199201 Lower Dose followed by 1 drop AGN-190584 Higher Dose, dominant eye--2 drops AGN-190584 vehicle; Treatment 3: nondominant eye--1 drop AGN-199201 Medium Dose followed by 1 drop AGN-190584 Higher Dose, dominant eye--2 drops AGN-190584 vehicle; Treatment 4: nondominant eye--1 drop AGN-199201 Higher Dose followed by 1 drop AGN-190584 Higher Dose, dominant eye--2 drops AGN-190584 vehicle; Treatment 5: nondominant eye--1 drop fixed combination of AGN-199201 and AGN-190584 followed by 1 drop AGN-190584 vehicle, dominant eye--2 drops AGN-190584 vehicle. |
| BG004 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| 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 |
|
| 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 | Weighted Average Change From Baseline in Mesopic, High Contrast Uncorrected Near Visual Acuity (UNVA) Letters | 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, Between hour 1 and hour 10 of each of the five 2-day dosing periods |
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Adverse events were collected for 112 days.
Safety Population: all subjects who received ≥ 1 administration of study treatment.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | AGN-190584 Vehicle and AGN-199201 | Participants will receive 5 different treatments as per protocol for 2 days each. Treatment 1: nondominant eye--1 drop AGN-199201 vehicle followed by 1 drop AGN-190584 vehicle, dominant eye--2 drops AGN-190584 vehicle; Treatment 2: nondominant eye--1 drop AGN-199201 Lower Dose followed by 1 drop AGN-190584 vehicle, dominant eye--2 drops AGN-190584 vehicle; Treatment 3: nondominant eye--1 drop AGN-199201 Medium Dose followed by 1 drop AGN-190584 vehicle, dominant eye--2 drops AGN-190584 vehicle; Treatment 4: nondominant eye--1 drop AGN-199201 Higher Dose followed by 1 drop AGN-190584 vehicle, dominant eye--2 drops AGN-190584 vehicle; Treatment 5: nondominant eye--1 drop fixed combination of AGN-199201 and AGN-190584 followed by 1 drop AGN-190584 vehicle, dominant eye--2 drops AGN-190584 vehicle. | 0 | 41 | 1 | 41 | 9 | 41 |
| EG001 | AGN-190584 Lower Dose and AGN-199201 | Participants will receive 5 different treatments as per protocol for 2 days each. Treatment 1: nondominant eye--1 drop AGN-199201 vehicle followed by 1 drop AGN-190584 Lower Dose, dominant eye--2 drops AGN-190584 vehicle; Treatment 2: nondominant eye--1 drop AGN-199201 Lower Dose followed by 1 drop AGN-190584 Lower Dose, dominant eye--2 drops AGN-190584 vehicle; Treatment 3: nondominant eye--1 drop AGN-199201 Medium Dose followed by 1 drop AGN-190584 Lower Dose, dominant eye--2 drops AGN-190584 vehicle; Treatment 4: nondominant eye--1 drop AGN-199201 Higher Dose followed by 1 drop AGN-190584 Lower Dose, dominant eye--2 drops AGN-190584 vehicle; Treatment 5: nondominant eye--1 drop fixed combination of AGN-199201 and AGN-190584 followed by 1 drop AGN-190584 vehicle, dominant eye--2 drops AGN-190584 vehicle. | 0 | 39 | 1 | 39 | 9 | 39 |
| EG002 | AGN-190584 Medium Dose and AGN-199201 | Participants will receive 5 different treatments as per protocol for 2 days each. Treatment 1: nondominant eye--1 drop AGN-199201 vehicle followed by 1 drop AGN-190584 Medium Dose, dominant eye--2 drops AGN-190584 vehicle; Treatment 2: nondominant eye--1 drop AGN-199201 Lower Dose followed by 1 drop AGN-190584 Medium Dose, dominant eye--2 drops AGN-190584 vehicle; Treatment 3: nondominant eye--1 drop AGN-199201 Medium Dose followed by 1 drop AGN-190584 Medium Dose, dominant eye--2 drops AGN-190584 vehicle; Treatment 4: nondominant eye--1 drop AGN-199201 Higher Dose followed by 1 drop AGN-190584 Medium Dose, dominant eye--2 drops AGN-190584 vehicle; Treatment 5: nondominant eye--1 drop fixed combination of AGN-199201 and AGN-190584 followed by 1 drop AGN-190584 vehicle, dominant eye--2 drops AGN-190584 vehicle. | 0 | 42 | 0 | 42 | 16 | 42 |
| EG003 | AGN-190584 Higher Dose and AGN-199201 | Participants will receive 5 different treatments as per protocol for 2 days each. Treatment 1: nondominant eye--1 drop AGN-199201 vehicle followed by 1 drop AGN-190584 Higher Dose, dominant eye--2 drops AGN-190584 vehicle; Treatment 2: nondominant eye--1 drop AGN-199201 Lower Dose followed by 1 drop AGN-190584 Higher Dose, dominant eye--2 drops AGN-190584 vehicle; Treatment 3: nondominant eye--1 drop AGN-199201 Medium Dose followed by 1 drop AGN-190584 Higher Dose, dominant eye--2 drops AGN-190584 vehicle; Treatment 4: nondominant eye--1 drop AGN-199201 Higher Dose followed by 1 drop AGN-190584 Higher Dose, dominant eye--2 drops AGN-190584 vehicle; Treatment 5: nondominant eye--1 drop fixed combination of AGN-199201 and AGN-190584 followed by 1 drop AGN-190584 vehicle, dominant eye--2 drops AGN-190584 vehicle. | 0 | 39 | 1 | 39 | 17 | 39 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cervix carcinoma stage 0 | Investigations | MedDRA Version 20.0 | Systematic Assessment |
| |
| Cholecystitis | Hepatobiliary disorders | MedDRA Version 20.0 | Systematic Assessment |
| |
| Malignant melanoma | Musculoskeletal and connective tissue disorders | MedDRA Version 20.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Instillation site pain | General disorders | MedDRA Version 20.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA Version 20.0 | Systematic Assessment |
| |
| Lacrimation increased | Eye disorders | MedDRA Version 20.0 | Systematic Assessment |
| |
| Foreign body sensation in eyes | Eye disorders | MedDRA Version 20.0 | Systematic Assessment |
| |
| Punctate keratitis | Eye disorders | MedDRA Version 20.0 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA Version 20.0 | Systematic Assessment |
| |
| Visual impairment | Eye disorders | MedDRA Version 20.0 | Systematic Assessment |
| |
| Visual acuity reduced | Eye disorders | MedDRA Version 20.0 | Systematic Assessment |
| |
| Vitreous floaters | Eye disorders | MedDRA Version 20.0 | Systematic Assessment |
|
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, Inc | 714-246-4500 | IR-CTRegistration@allergan.com |
| SAP_000.pdf |
| Prot | Yes | No | No | Study Protocol | Apr 4, 2016 | Oct 16, 2020 | Prot_001.pdf |
| ID | Term |
|---|---|
| D011305 | Presbyopia |
| ID | Term |
|---|---|
| D012030 | Refractive Errors |
| D005128 | Eye Diseases |
Not provided
Not provided
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| > 20/80 |
|
|
| AGN-199201 Lower Dose |
|
|
| AGN-199201 Medium Dose |
|
|
| AGN-199201 Higher Dose |
|
|
| Mixed model for repeated measures |
| <0.0001 |
| Least Squares (LS) |
| 6.6961 |
| Superiority |
| AGN-199201 Quadratic | Mixed model for repeated measures | 0.4126 | Least Squares (LS) | -69.890 | Superiority |
| AGN-199201 Linear | Mixed model for repeated measures | 0.3752 | Least Squares (LS) | 10.5017 | Superiority |