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The study will evaluate the safety and efficacy of AGN-210669 ophthalmic solution in comparison with AGN-210669 vehicle and bimatoprost ophthalmic solution dosed once-daily each morning, in subjects with ocular hypertension or primary open-angle glaucoma. Subjects will be followed for 2 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AGN-210669 ophthalmic solution, 0.075% | Experimental | AGN-210669 non-preserved ophthalmic solution, 0.075%. One drop in both eyes each morning once-daily for 2 weeks. |
|
| AGN-210669 ophthalmic solution, 0.05% | Experimental | AGN-210669 non-preserved ophthalmic solution, 0.05%. One drop in both eyes each morning once-daily for 2 weeks. |
|
| AGN-210669 ophthalmic solution, 0.025% | Experimental | AGN-210669 non-preserved ophthalmic solution, 0.025%. One drop in both eyes each morning once-daily for 2 weeks. |
|
| bimatoprost ophthalmic solution 0.03% | Active Comparator | Bimatoprost ophthalmic solution 0.03%. One drop in both eyes each morning once-daily for 2 weeks. |
|
| AGN-210669 vehicle ophthalmic solution | Placebo Comparator | AGN-210669 vehicle non-preserved ophthalmic solution. One drop in both eyes each morning once-daily for 2 weeks. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AGN-210669 ophthalmic solution, 0.075% | Drug | AGN-210669 non-preserved ophthalmic solution, 0.075%. One drop in both eyes each morning once-daily for 2 weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Average Eye Intraocular Pressure (IOP) | IOP is a measurement of the fluid pressure inside the eye. The average of the 2 eyes is 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). | Baseline, Day 14 Hour 0 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Patients With ≥ 20% Reduction From Baseline in Diurnal IOP | IOP is a measurement of the fluid pressure inside the eye. Diurnal IOP is the average of the IOP values of both eyes at each time point measured at protocol-specified times throughout the day. | Baseline, Day 14 |
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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 |
|---|---|---|---|---|---|---|
| Artesia | California | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | AGN-210669 Ophthalmic Solution, 0.075% | AGN-210669 non-preserved ophthalmic solution, 0.075%. One drop in both eyes each morning once-daily for 2 weeks. |
| FG001 | AGN-210669 Ophthalmic Solution, 0.05% |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| AGN-210669 ophthalmic solution, 0.05% | Drug | AGN-210669 non-preserved ophthalmic solution, 0.05%. One drop in both eyes each morning once-daily for 2 weeks. |
|
| AGN-210669 ophthalmic solution, 0.025% | Drug | AGN-210669 non-preserved ophthalmic solution, 0.025%. One drop in both eyes each morning once-daily for 2 weeks. |
|
| bimatoprost ophthalmic solution 0.03% | Drug | Bimatoprost ophthalmic solution 0.03%. One drop in both eyes each morning once-daily for 2 weeks. |
|
|
| AGN-210669 vehicle ophthalmic solution | Drug | AGN-210669 vehicle non-preserved ophthalmic solution. One drop in both eyes each morning once-daily for 2 weeks. |
|
AGN-210669 non-preserved ophthalmic solution, 0.05%. One drop in both eyes each morning once-daily for 2 weeks.
| FG002 | AGN-210669 Ophthalmic Solution, 0.025% | AGN-210669 non-preserved ophthalmic solution, 0.025%. One drop in both eyes each morning once-daily for 2 weeks. |
| FG003 | Bimatoprost Ophthalmic Solution 0.03% | Bimatoprost ophthalmic solution 0.03%. One drop in both eyes each morning once-daily for 2 weeks. |
| FG004 | AGN-210669 Vehicle Ophthalmic Solution | AGN-210669 vehicle non-preserved ophthalmic solution. One drop in both eyes each morning once-daily for 2 weeks. |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | AGN-210669 Ophthalmic Solution, 0.075% | AGN-210669 non-preserved ophthalmic solution, 0.075%. One drop in both eyes each morning once-daily for 2 weeks. |
| BG001 | AGN-210669 Ophthalmic Solution, 0.05% | AGN-210669 non-preserved ophthalmic solution, 0.05%. One drop in both eyes each morning once-daily for 2 weeks. |
| BG002 | AGN-210669 Ophthalmic Solution, 0.025% | AGN-210669 non-preserved ophthalmic solution, 0.025%. One drop in both eyes each morning once-daily for 2 weeks. |
| BG003 | Bimatoprost Ophthalmic Solution 0.03% | Bimatoprost ophthalmic solution 0.03%. One drop in both eyes each morning once-daily for 2 weeks. |
| BG004 | AGN-210669 Vehicle Ophthalmic Solution | AGN-210669 vehicle non-preserved ophthalmic solution. One drop in both eyes each morning once-daily for 2 weeks. |
| BG005 | 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, 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 Intraocular Pressure (IOP) | IOP is a measurement of the fluid pressure inside the eye. The average of the 2 eyes is 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). | Modified Intent to Treat: all randomized and treated patients who had at least a baseline visit and 1 postbaseline IOP evaluation | Posted | Mean | Standard Deviation | Millimeters of Mercury (mmHg) | Baseline, Day 14 Hour 0 |
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| Secondary | Percentage of Patients With ≥ 20% Reduction From Baseline in Diurnal IOP | IOP is a measurement of the fluid pressure inside the eye. Diurnal IOP is the average of the IOP values of both eyes at each time point measured at protocol-specified times throughout the day. | Modified Intent to Treat: all randomized and treated patients who had at least a baseline visit and 1 postbaseline IOP evaluation | Posted | Number | Percentage of Patients | Baseline, Day 14 |
|
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The Safety Population was used to assess adverse events (AEs) and serious adverse events (SAEs), and included all patients who were randomized and received at least 1 dose of study drug.
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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 Ophthalmic Solution, 0.075% | AGN-210669 non-preserved ophthalmic solution, 0.075%. One drop in both eyes each morning once-daily for 2 weeks. | 0 | 36 | 17 | 36 | ||
| EG001 | AGN-210669 Ophthalmic Solution, 0.05% | AGN-210669 non-preserved ophthalmic solution, 0.05%. One drop in both eyes each morning once-daily for 2 weeks. | 0 | 34 | 18 | 34 | ||
| EG002 | AGN-210669 Ophthalmic Solution, 0.025% | AGN-210669 non-preserved ophthalmic solution, 0.025%. One drop in both eyes each morning once-daily for 2 weeks. | 0 | 34 | 9 | 34 | ||
| EG003 | Bimatoprost Ophthalmic Solution 0.03% | Bimatoprost ophthalmic solution 0.03%. One drop in both eyes each morning once-daily for 2 weeks. | 0 | 31 | 20 | 31 | ||
| EG004 | AGN-210669 Vehicle Ophthalmic Solution | AGN-210669 vehicle non-preserved ophthalmic solution. One drop in both eyes each morning once-daily for 2 weeks. | 0 | 37 | 5 | 37 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Conjunctival Hyperaemia | Eye disorders | MedDRA version 10.0 | Systematic Assessment |
| |
| Photophobia | Eye disorders | MedDRA version 10.0 | Non-systematic Assessment |
| |
| Eye Pain | Eye disorders | MedDRA version 10.0 | Non-systematic Assessment |
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| Vision Blurred | Eye disorders | MedDRA version 10.0 | Non-systematic Assessment |
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| Punctate Keratitis | Eye disorders | MedDRA version 10.0 | Systematic Assessment |
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| Lacrimation Increased | Eye disorders | MedDRA version 10.0 | Non-systematic Assessment |
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| Eye Irritation | Eye disorders | MedDRA version 10.0 | Non-systematic Assessment |
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| Dry Eye | Eye disorders | MedDRA version 10.0 | 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 |
|---|---|
| D009798 | Ocular Hypertension |
| D005901 | Glaucoma |
| ID | Term |
|---|---|
| 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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| Between 45 and 65 years |
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| >65 years |
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| Male |
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| Change from Baseline at Day 14 - Hour 0 |
|
Bimatoprost ophthalmic solution 0.03%. One drop in both eyes each morning once-daily for 2 weeks. |
| OG004 | AGN-210669 Vehicle Ophthalmic Solution | AGN-210669 vehicle non-preserved ophthalmic solution. One drop in both eyes each morning once-daily for 2 weeks. |
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