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This safety study will evaluate bimatoprost 0.01% and 0.03% in patients with glaucoma or ocular hypertension (OHT).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Bimatoprost 0.01% | Experimental | Bimatoprost 0.01% (LUMIGAN® 0.01%) administered each evening in both eyes for 6 weeks. |
|
| Bimatoprost 0.03% | Active Comparator | Bimatoprost 0.03% (LUMIGAN® 0.03%) administered each evening in both eyes for 6 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bimatoprost 0.01% | Drug | Bimatoprost 0.01% (LUMIGAN® 0.01%) administered each evening in both eyes for 6 weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Patients With an Increase in Macroscopic Conjunctival Hyperemia in Either Eye | Macroscopic conjunctival hyperemia (eye redness) is graded in each eye on a 5-point scale (Scale 0 to +3: none, trace, mild, moderate, severe). An increase (worsening) in macroscopic conjunctival hyperemia is defined as an increase in macroscopic conjunctival hyperemia grade of at least 1 from baseline in either eye. | Baseline, 6 Weeks |
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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 | Bimatoprost 0.01% | Bimatoprost 0.01% (LUMIGAN® 0.01%) administered each evening in both eyes for 6 weeks. |
| FG001 | Bimatoprost 0.03% | Bimatoprost 0.03% (LUMIGAN® 0.03%) administered each evening in both eyes for 6 weeks. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Bimatoprost 0.01% | Bimatoprost 0.01% (LUMIGAN® 0.01%) administered each evening in both eyes for 6 weeks. |
| BG001 | Bimatoprost 0.03% | Bimatoprost 0.03% (LUMIGAN® 0.03%) administered each evening in both eyes for 6 weeks. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Number |
| 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 | Percentage of Patients With an Increase in Macroscopic Conjunctival Hyperemia in Either Eye | Macroscopic conjunctival hyperemia (eye redness) is graded in each eye on a 5-point scale (Scale 0 to +3: none, trace, mild, moderate, severe). An increase (worsening) in macroscopic conjunctival hyperemia is defined as an increase in macroscopic conjunctival hyperemia grade of at least 1 from baseline in either eye. | Intent-to-Treat: all randomized patients | Posted | Number | Percentage of Patients | Baseline, 6 Weeks |
|
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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 | Bimatoprost 0.01% | Bimatoprost 0.01% (LUMIGAN® 0.01%) administered each evening in both eyes for 6 weeks. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Arthritis | Musculoskeletal and connective tissue disorders | MedDRA version 17.0 | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Eye Pruritus | Eye disorders | MedDRA version 17.0 | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Therapeutic Area Head, | Allergan, Inc | 714-246-4500 | clinicaltrials@allergan.com |
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| ID | Term |
|---|---|
| D005901 | Glaucoma |
| D009798 | Ocular Hypertension |
| ID | Term |
|---|---|
| D005128 | Eye Diseases |
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| Bimatoprost 0.03% | Drug | Bimatoprost 0.03% (LUMIGAN® 0.03%) administered each evening in both eyes for 6 weeks. |
|
|
| El Paso |
| Texas |
| United States |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
Bimatoprost 0.03% (LUMIGAN® 0.03%) administered each evening in both eyes for 6 weeks.
|
|
| 2 |
| 233 |
| 49 |
| 233 |
| EG001 | Bimatoprost 0.03% | Bimatoprost 0.03% (LUMIGAN® 0.03%) administered each evening in both eyes for 6 weeks. | 2 | 233 | 66 | 233 |
| Cerebrovascular Accident | Nervous system disorders | MedDRA version 17.0 | Systematic Assessment |
|
| Monoplegia | Nervous system disorders | MedDRA version 17.0 | Non-systematic Assessment |
|
| Cholecystitis | Hepatobiliary disorders | MedDRA version 17.0 | Systematic Assessment |
|
| Prostate Cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 17.0 | Systematic Assessment |
|
| Conjunctival Hyperaemia | Eye disorders | MedDRA version 17.0 | 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.