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This study has 2 parts. Part 1 will evaluate the safety and IOP effects of 6 formulations of AGN-210961 ophthalmic solution in the study eye and bimatoprost ophthalmic solution 0.03% in the fellow eye for 7 consecutive days. Part 2 will evaluate the safety and IOP effects of a formulation (to be selected from part 1) of AGN-210961 in both eyes compared to bimatoprost ophthalmic solution 0.03% for 4 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part 1, AGN-210961 Formulation 1 | Experimental | AGN-210961 Formulation 1 in one eye and bimatoprost ophthalmic solution 0.03% in the other eye once daily for 7 days. |
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| Part 1, AGN-210961 Formulation 2 | Experimental | AGN-210961 Formulation 2 in one eye and bimatoprost ophthalmic solution 0.03% in the other eye once daily for 7 days. |
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| Part 1, AGN-210961 Formulation 3 | Experimental | AGN-210961 Formulation 3 in one eye and bimatoprost ophthalmic solution 0.03% in the other eye once daily for 7 days. |
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| Part 1, AGN-210961 Formulation 4 | Experimental | AGN-210961 Formulation 4 in one eye and bimatoprost ophthalmic solution 0.03% in the other eye once daily for 7 days. |
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| Part 1, AGN-210961 Formulation 5 | Experimental | AGN-210961 Formulation 5 in one eye and bimatoprost ophthalmic solution 0.03% in the other eye once daily for 7 days. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AGN-210961 Formulation 1 | Drug | AGN-210961 Formulation 1 in one eye once daily for 7 days. |
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| Measure | Description | Time Frame |
|---|---|---|
| Part 1: Change From Baseline in Intraocular Pressure (IOP) | IOP is a measurement of the fluid pressure inside the eye. Data are recorded at Hours 0, 2, 4, 6, 8, and 12. A negative number change from Baseline indicated a reduction in IOP (improvement). Data for bimatoprost-treated eyes are combined across groups. | Baseline, Day 7 |
| Part 2: Change From Baseline in Average Eye Intraocular Pressure (IOP) | IOP is a measurement of the fluid pressure inside the eye. Average IOP is the average of the 2 eyes for each patient at each time point. A negative number change from Baseline indicates a reduction in IOP (improvement). Data are recorded at Hours 0, 2, 4, 6, 8, and 12. | Baseline, Day 29 |
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Inclusion Criteria:
- Ocular hypertension or primary open-angle glaucoma in each eye
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 |
This was a 2-part study. Patients were enrolled in and completed Part 1 of the study. Then, based on a review of the data from Part 1, a different formulation was selected for Part 2 (Formulation 7). New patients were then enrolled in Part 2 of the study. No patients from Part 1 were enrolled in Part 2 of the study.
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| ID | Title | Description |
|---|---|---|
| FG000 | Part 1, AGN-210961 Formulation 1 | AGN-210961 Formulation 1 in one eye and bimatoprost ophthalmic solution 0.03% in the other eye once daily for 7 days. |
| FG001 | Part 1, AGN-210961 Formulation 2 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Part 1, AGN-210961 Formulation 6 | Experimental | AGN-210961 Formulation 6 in one eye and bimatoprost ophthalmic solution 0.03% in the other eye once daily for 7 days. |
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| Part 2, AGN-210961 Formulation 7 | Experimental | AGN-210961 Formulation 7 in both eyes once daily for 4 weeks. |
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| Part 2, bimatoprost ophthalmic solution 0.03% | Active Comparator | bimatoprost ophthalmic solution 0.03% in both eyes once daily for 4 weeks. |
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| AGN-210961 Formulation 2 | Drug | AGN-210961 Formulation 2 in one eye once daily for 7 days. |
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| AGN-210961 Formulation 3 | Drug | AGN-210961 Formulation 3 in one eye once daily for 7 days. |
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| AGN-210961 Formulation 4 | Drug | AGN-210961 Formulation 4 in one eye once daily for 7 days. |
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| AGN-210961 Formulation 5 | Drug | AGN-210961 Formulation 5 in one eye once daily for 7 days. |
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| AGN-210961 Formulation 6 | Drug | AGN-210961 Formulation 6 in one eye once daily for 7 days. |
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| AGN-210961 Formulation 7 | Drug | AGN-210961 Formulation 7 in both eyes once daily for 4 weeks. |
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| bimatoprost ophthalmic solution 0.03% | Drug | bimatoprost ophthalmic solution 0.03% (LUMIGAN®) in both eyes once daily for 4 weeks. |
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AGN-210961 Formulation 2 in one eye and bimatoprost ophthalmic solution 0.03% in the other eye once daily for 7 days.
| FG002 | Part 1, AGN-210961 Formulation 3 | AGN-210961 Formulation 3 in one eye and bimatoprost ophthalmic solution 0.03% in the other eye once daily for 7 days. |
| FG003 | Part 1, AGN-210961 Formulation 4 | AGN-210961 Formulation 4 in one eye and bimatoprost ophthalmic solution 0.03% in the other eye once daily for 7 days. |
| FG004 | Part 1, AGN-210961 Formulation 5 | AGN-210961 Formulation 5 in one eye and bimatoprost ophthalmic solution 0.03% in the other eye once daily for 7 days. |
| FG005 | Part 1, AGN-210961 Formulation 6 | AGN-210961 Formulation 6 in one eye and bimatoprost ophthalmic solution 0.03% in the other eye once daily for 7 days. |
| FG006 | Part 2, AGN-210961 Formulation 7 | AGN-210961 Formulation 7 (a different formulation from those used in Part 1) in both eyes once daily for 4 weeks. |
| FG007 | Part 2, Bimatoprost Ophthalmic Solution 0.03% | bimatoprost ophthalmic solution 0.03% in both eyes once daily for 4 weeks. |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Part 1, AGN-210961 Formulation 1 | AGN-210961 Formulation 1 in one eye and bimatoprost ophthalmic solution 0.03% in the other eye once daily for 7 days. |
| BG001 | Part 1, AGN-210961 Formulation 2 | AGN-210961 Formulation 2 in one eye and bimatoprost ophthalmic solution 0.03% in the other eye once daily for 7 days. |
| BG002 | Part 1, AGN-210961 Formulation 3 | AGN-210961 Formulation 3 in one eye and bimatoprost ophthalmic solution 0.03% in the other eye once daily for 7 days. |
| BG003 | Part 1, AGN-210961 Formulation 4 | AGN-210961 Formulation 4 in one eye and bimatoprost ophthalmic solution 0.03% in the other eye once daily for 7 days. |
| BG004 | Part 1, AGN-210961 Formulation 5 | AGN-210961 Formulation 5 in one eye and bimatoprost ophthalmic solution 0.03% in the other eye once daily for 7 days. |
| BG005 | Part 1, AGN-210961 Formulation 6 | AGN-210961 Formulation 6 in one eye and bimatoprost ophthalmic solution 0.03% in the other eye once daily for 7 days. |
| BG006 | Part 2, AGN-210961 Formulation 7 | AGN-210961 Formulation 7 (a different formulation from those used in Part 1) in both eyes once daily for 4 weeks. |
| BG007 | Part 2, Bimatoprost Ophthalmic Solution 0.03% | bimatoprost ophthalmic solution 0.03% in both eyes once daily for 4 weeks. |
| BG008 | 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 | Part 1: Change From Baseline in Intraocular Pressure (IOP) | IOP is a measurement of the fluid pressure inside the eye. Data are recorded at Hours 0, 2, 4, 6, 8, and 12. A negative number change from Baseline indicated a reduction in IOP (improvement). Data for bimatoprost-treated eyes are combined across groups. | Safety Population: all treated patients | Posted | Mean | Standard Deviation | Millimeters of Mercury (mmHg) | Baseline, Day 7 | Eyes | Participants |
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| Primary | Part 2: Change From Baseline in Average Eye Intraocular Pressure (IOP) | IOP is a measurement of the fluid pressure inside the eye. Average IOP is the average of the 2 eyes for each patient at each time point. A negative number change from Baseline indicates a reduction in IOP (improvement). Data are recorded at Hours 0, 2, 4, 6, 8, and 12. | Modified Intent to Treat: all randomized and treated patients who provided IOP data for baseline and at least one postbaseline hour 0 assessment | Posted | Mean | Standard Deviation | Millimeters of Mercury (mmHg) | Baseline, Day 29 |
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AEs and SAEs are reported for all treated patients. In Part 1, ocular AEs for bimatoprost treated eye are noted in "Part 1, bimatoprost 0.03% treated eye" only and those for AGN-210961 Formulations 1-6 eyes are noted in "Part 1, AGN-210961 Formulations 1-6". In Part 1, non-ocular AEs are reported only in "Part 1, AGN-210961 Formulations 1-6" arms.
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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 | Part 1, AGN-210961 Formulation 1 | AGN-210961 Formulation 1 in one eye and bimatoprost ophthalmic solution 0.03% in the other eye once daily for 7 days. | 0 | 14 | 10 | 14 | ||
| EG001 | Part 1, AGN-210961 Formulation 2 | AGN-210961 Formulation 2 in one eye and bimatoprost ophthalmic solution 0.03% in the other eye once daily for 7 days. | 0 | 14 | 9 | 14 | ||
| EG002 | Part 1, AGN-210961 Formulation 3 | AGN-210961 Formulation 3 in one eye and bimatoprost ophthalmic solution 0.03% in the other eye once daily for 7 days. | 0 | 14 | 10 | 14 | ||
| EG003 | Part 1, AGN-210961 Formulation 4 | AGN-210961 Formulation 4 in one eye and bimatoprost ophthalmic solution 0.03% in the other eye once daily for 7 days. | 0 | 14 | 6 | 14 | ||
| EG004 | Part 1, AGN-210961 Formulation 5 | AGN-210961 Formulation 5 in one eye and bimatoprost ophthalmic solution 0.03% in the other eye once daily for 7 days. | 0 | 14 | 7 | 14 | ||
| EG005 | Part 1, AGN-210961 Formulation 6 | AGN-210961 Formulation 6 in one eye and bimatoprost ophthalmic solution 0.03% in the other eye once daily for 7 days. | 0 | 14 | 5 | 14 | ||
| EG006 | Part 1, Bimatoprost Ophthalmic Solution 0.03% Treated Eye | bimatoprost ophthalmic solution 0.03% in the non-study eye once daily for 7 days (all bimatoprost ophthalmic solution 0.03% treated eyes in Part 1 combined). | 0 | 84 | 53 | 84 | ||
| EG007 | Part 2, AGN-210961 Formulation 7 | AGN-210961 Formulation 7 (a different formulation from those used in Part 1) in both eyes once daily for 4 weeks. | 1 | 39 | 29 | 39 | ||
| EG008 | Part 2, Bimatoprost Ophthalmic Solution 0.03% | bimatoprost ophthalmic solution 0.03% in both eyes once daily for 4 weeks. | 1 | 40 | 19 | 40 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA version 14.0 | Non-systematic Assessment |
| |
| Lip and/or Oral Cavity Cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 14.0 | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Conjunctival Hyperaemia | Eye disorders | MedDRA version 14.0 | Systematic Assessment |
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| Punctate Keratitis | Eye disorders | MedDRA version 14.0 | Systematic Assessment |
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| Corneal thickening | 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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| Hypercholesterolaemia | Metabolism and nutrition disorders | MedDRA version 14.0 | Systematic Assessment |
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| Vision Blurred | 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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| Iritis | Eye disorders | MedDRA version 14.0 | Systematic Assessment |
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| Lacrimation Increased | 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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| Bundle Branch Block Right | Cardiac 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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| Headache | Nervous system disorders | MedDRA version 14.0 | Non-systematic Assessment |
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| Upper Respiratory Infection | Infections and infestations | 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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| Hemicephalalgia | Nervous system disorders | MedDRA version 14.0 | Systematic Assessment |
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| Eye Discharge | Eye disorders | MedDRA version 14.0 | Non-systematic Assessment |
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| Visual Acuity Reduced | Eye disorders | MedDRA version 14.0 | 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 |
| D005902 | Glaucoma, Open-Angle |
| ID | Term |
|---|---|
| D005128 | Eye Diseases |
| D005901 | Glaucoma |
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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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| Eyes |
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| Baseline - Hour 2 |
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| Baseline - Hour 4 |
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| Baseline - Hour 6 |
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| Baseline - Hour 8 |
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| Baseline - Hour 12 |
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| Change from Baseline at Day 7- Hour 0 |
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| Change from Baseline at Day 7- Hour 2 |
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| Change from Baseline at Day 7- Hour 4 |
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| Change from Baseline at Day 7 - Hour 6 |
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| Change from Baseline at Day 7- Hour 8 |
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| Change from Baseline at Day 7- Hour 12 |
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