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This study will evaluate the safety and efficacy of AGN-210669 ophthalmic solution compared with bimatoprost ophthalmic solution (Lumigan®) as monotherapy and adjunctive therapy in patients with primary open-angle glaucoma or ocular hypertension.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AGN-210669 | Experimental | AGN-210669 0.05% applied as 1 drop in both eyes every evening during Month 1. |
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| AGN-210669 + bimatoprost | Experimental | AGN-210669 0.05% + bimatoprost ophthalmic solution 0.03% applied as 1 drop of each treatment in both eyes every evening during Month 2. |
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| AGN-210669 + bimatoprost vehicle | Experimental | AGN-210669 0.05% + bimatoprost ophthalmic solution 0.03% vehicle applied as 1 drop of each treatment in both eyes every evening during Month 2. |
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| bimatoprost | Active Comparator | bimatoprost ophthalmic solution 0.03% applied as 1 drop in both eyes every evening during Month 1. |
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| bimatoprost + AGN-210669 | Experimental | bimatoprost ophthalmic solution 0.03% + AGN-210669 0.05% applied as 1 drop of each treatment in both eyes every evening during Month 2. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AGN-210669 | Drug | AGN-210669 0.05% applied as 1 drop in both eyes every evening during Month 1 or Month 2. |
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| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Average Eye IOP | IOP is a measurement of the fluid pressure inside the eye. The average of the 2 eyes are used for the analyses. A negative number change from baseline indicates a reduction in IOP (improvement) and a positive number change from baseline indicates an increase in IOP (worsening). Data are recorded at Hours 0, 4, 8, and 12. | Baseline, Day 57 |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Worse Eye IOP | IOP is a measurement of the fluid pressure inside the eye. The worse eye IOP refers to eye with the worse baseline IOP, which is determined as the eye with the higher mean diurnal IOP at baseline. If both eyes have the same mean diurnal IOP at baseline, the right eye is designated as the worse eye. A negative number change from baseline indicates a reduction in IOP (improvement) and a positive number change from baseline indicates an increase in IOP (worsening). Data are recorded at Hours 0, 4, 8, and 12. |
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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 |
|---|---|---|---|---|---|---|
| Austin | Texas | United States |
Pts were randomized at Baseline for the entire study. At Mo 1, pts received either AGN-210669 or bimatoprost. At Mo 2, pts who had received AGN-210669, then received either AGN-210669+bimatoprost or AGN-210669+bimatoprost vehicle and pts who had received bimatoprost, then received either bimatoprost+AGN-210669 or bimatoprost+bimatoprost vehicle.
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| ID | Title | Description |
|---|---|---|
| FG000 | AGN-210669 | AGN-210669 0.05% applied as 1 drop in both eyes every evening during Month 1. |
| FG001 | AGN-210669 + Bimatoprost | AGN-210669 0.05% + bimatoprost ophthalmic solution 0.03% applied as 1 drop of each treatment in both eyes every evening during Month 2. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Month 1 (Monotherapy) |
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| bimatoprost + bimatoprost vehicle | Other | bimatoprost ophthalmic solution 0.03% + bimatoprost ophthalmic solution 0.03% vehicle applied as 1 drop of each treatment in both eyes every evening during Month 2. |
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| bimatoprost | Drug | bimatoprost ophthalmic solution 0.03% applied as 1 drop in both eyes every evening during Month 1 or Month 2. |
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| bimatoprost vehicle | Drug | bimatoprost ophthalmic solution 0.03% vehicle applied as 1 drop in both eyes every evening during Month 2. |
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| Baseline, Day 57 |
| FG002 | AGN-210669 + Bimatoprost Vehicle | AGN-210669 0.05% + bimatoprost ophthalmic solution 0.03% vehicle applied as 1 drop of each treatment in both eyes every evening during Month 2. |
| FG003 | Bimatoprost | bimatoprost ophthalmic solution 0.03% applied as 1 drop in both eyes every evening during Month 1. |
| FG004 | Bimatoprost + AGN-210669 | bimatoprost ophthalmic solution 0.03% + AGN-210669 0.05% applied as 1 drop of each treatment in both eyes every evening during Month 2. |
| FG005 | Bimatoprost + Bimatoprost Vehicle | bimatoprost ophthalmic solution 0.03% + bimatoprost ophthalmic solution 0.03% vehicle applied as 1 drop of each treatment in both eyes every evening during Month 2. |
| COMPLETED |
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| NOT COMPLETED |
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| Month 2 (Adjunctive Therapy) |
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| ID | Title | Description |
|---|---|---|
| BG000 | AGN-210669 Followed by AGN-210669 + Bimatoprost | AGN-210669 0.05% applied as 1 drop in each eye every evening for Month 1 followed by AGN-210669 0.05% + bimatoprost 0.03% applied as 1 drop of each treatment in both eyes every evening for Month 2. |
| BG001 | AGN-210669 Followed by AGN-210669 + Bimatoprost Vehicle | AGN-210669 0.05% applied as 1 drop in each eye every evening for Month 1 followed by AGN-210669 0.05% + bimatoprost 0.03% vehicle applied as 1 drop of each treatment in both eyes every evening for Month 2. |
| BG002 | Bimatoprost Followed by Bimatoprost + AGN-210669 | bimatoprost 0.03% applied as 1 drop in each eye every evening for Month 1 followed by bimatoprost 0.03% + AGN-210669 applied as 1 drop of each treatment in both eyes every evening for Month 2. |
| BG003 | Bimatoprost Followed by Bimatoprost + Bimatoprost Vehicle | bimatoprost 0.03% applied as 1 drop in each eye every evening for Month 1 followed by bimatoprost 0.03% + bimatoprost 0.03% vehicle applied as 1 drop of each treatment in both eyes every evening for Month 2. |
| BG004 | 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 |
| ||||||||||||||||
| 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 | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change From Baseline in Average Eye IOP | IOP is a measurement of the fluid pressure inside the eye. The average of the 2 eyes are used for the analyses. A negative number change from baseline indicates a reduction in IOP (improvement) and a positive number change from baseline indicates an increase in IOP (worsening). Data are recorded at Hours 0, 4, 8, and 12. | Modified Intent to Treat: all randomized and treated patients who had a baseline and at least 1 post-baseline IOP measurement | Posted | Mean | Standard Deviation | Millimeters of Mercury (mmHg) | Baseline, Day 57 |
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| Secondary | Change From Baseline in Worse Eye IOP | IOP is a measurement of the fluid pressure inside the eye. The worse eye IOP refers to eye with the worse baseline IOP, which is determined as the eye with the higher mean diurnal IOP at baseline. If both eyes have the same mean diurnal IOP at baseline, the right eye is designated as the worse eye. A negative number change from baseline indicates a reduction in IOP (improvement) and a positive number change from baseline indicates an increase in IOP (worsening). Data are recorded at Hours 0, 4, 8, and 12. | Modified Intent to Treat: all randomized and treated patients who had a baseline and at least 1 post-baseline IOP measurement | Posted | Mean | Standard Deviation | Millimeters of Mercury (mmHg) | Baseline, Day 57 |
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The Safety Population was used to assess adverse events (AEs) and serious adverse events (SAEs) and included all treated patients. SAEs and AEs are presented by treatment arm not necessarily by individual treatment received.
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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-210669 | AGN-210669 0.05% applied as 1 drop in both eyes every evening during Month 1. | 0 | 65 | 43 | 65 | ||
| EG001 | AGN-210669 + Bimatoprost | AGN-210669 0.05% + bimatoprost ophthalmic solution 0.03% applied as 1 drop of each treatment in both eyes every evening during Month 2. | 0 | 40 | 31 | 40 | ||
| EG002 | AGN-210669 + Bimatoprost Vehicle | AGN-210669 0.05% + bimatoprost ophthalmic solution 0.03% vehicle applied as 1 drop of each treatment in both eyes every evening during Month 2. | 0 | 24 | 11 | 24 | ||
| EG003 | Bimatoprost | bimatoprost ophthalmic solution 0.03% applied as 1 drop in both eyes every evening during Month 1. | 0 | 60 | 41 | 60 | ||
| EG004 | Bimatoprost + AGN-210669 | bimatoprost ophthalmic solution 0.03% + AGN-210669 0.05% applied as 1 drop of each treatment in both eyes every evening during Month 2. | 0 | 34 | 26 | 34 | ||
| EG005 | Bimatoprost + Bimatoprost Vehicle | bimatoprost ophthalmic solution 0.03% + bimatoprost ophthalmic solution 0.03% vehicle applied as 1 drop of each treatment in both eyes every evening during Month 2. | 1 | 26 | 15 | 26 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Uveal Prolapse | Injury, poisoning and procedural complications | MedDRA version 14.0 | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Corneal Thickening | Eye disorders | MedDRA version 14.0 | Systematic Assessment |
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| Conjunctival Hyperaemia | Eye disorders | MedDRA version 14.0 | Systematic Assessment |
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| Eye Irritation | Eye disorders | MedDRA version 14.0 | Non-systematic Assessment |
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| Eye Discharge | Eye disorders | MedDRA version 14.0 | Non-systematic Assessment |
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| Vision Blurred | Eye disorders | MedDRA version 14.0 | Non-systematic Assessment |
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| Eye Pruritus | Eye disorders | MedDRA version 14.0 | Non-systematic Assessment |
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| Punctate Keratitis | Eye disorders | MedDRA version 14.0 | Systematic Assessment |
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| Photophobia | Eye disorders | MedDRA version 14.0 | Non-systematic Assessment |
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| Foreign Body Sensation in Eyes | Eye disorders | MedDRA version 14.0 | Non-systematic Assessment |
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| Eye Pain | Eye disorders | MedDRA version 14.0 | Non-systematic Assessment |
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| Lacrimation Increased | Eye disorders | MedDRA version 14.0 | Non-systematic Assessment |
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| Iritis | Eye disorders | MedDRA version 14.0 | Systematic Assessment |
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| Anterior Chamber Cell | Eye disorders | MedDRA version 14.0 | Systematic Assessment |
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| Asthenopia | Eye disorders | MedDRA version 14.0 | Non-systematic Assessment |
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| Keratitis | Eye disorders | MedDRA version 14.0 | 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, 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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| ID | Term |
|---|---|
| D000069580 | Bimatoprost |
| ID | Term |
|---|---|
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D003008 | Cloprostenol |
| D011461 | Prostaglandins F, Synthetic |
| D011465 | Prostaglandins, Synthetic |
| D011453 | Prostaglandins |
| D015777 | Eicosanoids |
| D005231 | Fatty Acids, Unsaturated |
| D005227 | Fatty Acids |
| D008055 | Lipids |
| D012898 | Autacoids |
| D018836 | Inflammation Mediators |
| D001685 | Biological Factors |
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| 45 to 65 years |
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| >65 years |
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| Male |
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| Baseline - Hour 8 |
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| Baseline - Hour 12 |
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| Change from Baseline at Day 57-Hr 0 (n=24,25,72) |
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| Change from Baseline at Day 57-Hr 4 (n=24,25,72) |
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| Change from Baseline at Day 57-Hr 8 (n=24,25,72) |
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| Change from Baseline at Day 57-Hr 12 (n=16,17,56) |
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Combined adjunctives refer to the combined groups of 'AGN-210669 0.05% + bimatoprost' and 'bimatoprost + AGN-210669 0.05%'. The first treatment is applied as 1 drop in each eye every evening for Month 1 followed by AGN-210669 0.05% + bimatoprost 0.03% applied as 1 drop of each treatment in both eyes every evening for Month 2.
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