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This is an exploratory study that will evaluate the safety and pharmacodynamics of up to 3 doses of AGN-207281 based on an ongoing review of data during the study period compared with timolol ophthalmic solution or placebo in patients with ocular hypertension or primary open-angle glaucoma.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AGN-207281 ophthalmic solution | Other | AGN-207281 0.1% ophthalmic solution on Days 1-7 and AGN-207281 0.3% ophthalmic solution on Days 8-14 |
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| Timolol ophthalmic solution 0.5% | Active Comparator | timolol ophthalmic solution 0.5% |
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| Placebo | Placebo Comparator | AGN-207281 vehicle ophthalmic solution (Placebo) |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AGN-207281 ophthalmic solutions (0.1% and 0.3%); AGN-207281 vehicle ophthalmic solution (placebo) | Drug | One drop of AGN-207281 ophthalmic solutions (0.1% on Days 1-7 and 0.3% on Days 8-14) instilled to both eyes in the morning followed by one drop of AGN-207281 vehicle ophthalmic solution (placebo) instilled to both eyes in the evening for 13 days. |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Worse Eye Intraocular Pressure (IOP) at Day 14 | Change from baseline in worse eye IOP at day 14. Worse eye IOP refers to the eye with the worse (highest) baseline IOP (a measurement of the fluid pressure inside the eye). A negative number change from baseline indicates a reduction in IOP (improvement). | Baseline, Day 14 |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Concentration of AGN-207281 in Plasma at Day 7 | Mean concentration of AGN-207281 in plasma at day 7. Plasma is the liquid component of the blood in which the blood cells are suspended. On day 7, the plasma sample collected 15 minutes post-morning dose from each patient receiving AGN-207281 was analyzed to determine the average drug concentration levels of AGN-207281. | Day 7 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Allergan | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Newport Beach | California | United States |
Patients in the AGN-207281 ophthalmic solution arm received AGN-207281 ophthalmic solution 0.1% on Days 1 to 7 and AGN-207281 ophthalmic solution 0.3% on Days 8 to 14.
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| ID | Title | Description |
|---|---|---|
| FG000 | AGN-207281 Ophthalmic Solution | AGN-207281 0.1% ophthalmic solution on Days 1-7 and AGN-207281 0.3% ophthalmic solution on Days 8-14 |
| FG001 | Timolol Ophthalmic Solution 0.5% | timolol ophthalmic solution 0.5% |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| timolol ophthalmic solution 0.5% | Drug | One drop of timolol ophthalmic solution 0.5% instilled to both eyes, in the morning for 14 days, and in the evening for 13 days |
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| AGN-207281 vehicle ophthalmic solution (Placebo) | Drug | One drop of AGN-207281 vehicle ophthalmic solution instilled to both eyes, in the morning for 14 days and in the evening for 13 days. |
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| Mean Concentration of AGN-207281 in Plasma at Day 14 | Mean concentration of AGN-207281 in plasma at day 14. Plasma is the liquid component of the blood in which the blood cells are suspended. On day 14, the plasma sample collected 15 minutes post-morning dose from each patient receiving AGN-207281 was analyzed to determine the average drug concentration levels of AGN-207281. | Day 14 |
| FG002 | Placebo | AGN-207281 vehicle ophthalmic solution (Placebo) |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | AGN-207281 Ophthalmic Solution | AGN-207281 0.1% ophthalmic solution on Days 1-7 and AGN-207281 0.3% ophthalmic solution on Days 8-14 |
| BG001 | Timolol Ophthalmic Solution 0.5% | timolol ophthalmic solution 0.5% |
| BG002 | Placebo | AGN-207281 vehicle ophthalmic solution (Placebo) |
| BG003 | 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, Customized | Number | participants |
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| Sex: Female, Male | 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 | Change From Baseline in Worse Eye Intraocular Pressure (IOP) at Day 14 | Change from baseline in worse eye IOP at day 14. Worse eye IOP refers to the eye with the worse (highest) baseline IOP (a measurement of the fluid pressure inside the eye). A negative number change from baseline indicates a reduction in IOP (improvement). | Safety population, which consisted of all patients who started the study and received treatment. | Posted | Mean | Standard Deviation | Millimeters of mercury (mm Hg) | Baseline, Day 14 |
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| Secondary | Mean Concentration of AGN-207281 in Plasma at Day 7 | Mean concentration of AGN-207281 in plasma at day 7. Plasma is the liquid component of the blood in which the blood cells are suspended. On day 7, the plasma sample collected 15 minutes post-morning dose from each patient receiving AGN-207281 was analyzed to determine the average drug concentration levels of AGN-207281. | The analysis population included all patients that started the study and were treated with AGN-207281. | Posted | Mean | Standard Deviation | Picograms per milliliter (pg/mL) | Day 7 |
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| Secondary | Mean Concentration of AGN-207281 in Plasma at Day 14 | Mean concentration of AGN-207281 in plasma at day 14. Plasma is the liquid component of the blood in which the blood cells are suspended. On day 14, the plasma sample collected 15 minutes post-morning dose from each patient receiving AGN-207281 was analyzed to determine the average drug concentration levels of AGN-207281. | The analysis population included all patients that started the study and were treated with AGN-207281. | Posted | Mean | Standard Deviation | Picograms per milliliter (pg/mL) | Day 14 |
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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 | AGN-207281 Ophthalmic Solution | AGN-207281 0.1% ophthalmic solution on Days 1-7 and AGN-207281 0.3% ophthalmic solution on Days 8-14 | 0 | 21 | 9 | 21 | ||
| EG001 | Timolol Ophthalmic Solution 0.5% | timolol ophthalmic solution 0.5% | 0 | 19 | 19 | 19 | ||
| EG002 | Placebo | AGN-207281 vehicle ophthalmic solution (Placebo) | 0 | 10 | 2 | 10 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Eye irritation | Eye disorders | MedDRA (13.1) | Non-systematic Assessment |
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| Eye pain | Eye disorders | MedDRA (13.1) | Non-systematic Assessment |
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| Lacrimation increased | Eye disorders | MedDRA (13.1) | Non-systematic Assessment |
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| Punctate keratitis | Eye disorders | MedDRA (13.1) | Systematic Assessment |
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| Eye discharge | Eye disorders | MedDRA (13.1) | Non-systematic Assessment |
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| Vision blurred | Eye disorders | MedDRA (13.1) | Non-systematic Assessment |
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| Joint sprain | Injury, poisoning and procedural complications | MedDRA (13.1) | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA (13.1) | Non-systematic Assessment |
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| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (13.1) | Non-systematic Assessment |
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| Foreign body sensation in eyes | Eye disorders | MedDRA (13.1) | Non-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, Inc. | 714-246-4500 | clinicaltrials@allergan.com |
| ID | Term |
|---|---|
| D005902 | Glaucoma, Open-Angle |
| D009798 | Ocular Hypertension |
| ID | Term |
|---|---|
| D005901 | Glaucoma |
| D005128 | Eye Diseases |
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| Between 45 and 65 years |
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| >65 years |
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| Male |
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| Baseline, Hour 8 |
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| Change from Baseline at Day 14, Hour 0 |
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| Change from Baseline at Day 14, Hour 2 |
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| Change from Baseline at Day 14, Hour 8 |
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