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This study is a Post-Marketing Surveillance study in Korea to evaluate the safety and efficacy of Combigan® (brimonidine tartrate/timolol maleate) Ophthalmic Solution in patients with Open Angle Glaucoma or Ocular hypertension with insufficient response to local beta blockers treated as per standard of care in clinical practice.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Combigan® Ophthalmic Solution | Patients treated with Combigan® Ophthalmic Solution as per local standard of care in clinical practice. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| brimonidine tartrate/timolol maleate Ophthalmic Solution | Drug | brimonidine tartrate/timolol maleate (Combigan®) Ophthalmic Solution as per local standard of care in clinical practice. |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Reporting Adverse Events | An adverse event was any unfavorable and unintended sign, symptom, or disease associated with the use of the study drug, whether or not considered related to the study drug. | Up to 2.6 Years |
| Percentage of Participants With Overall Improvement From Baseline in Intraocular Pressure (IOP) | IOP is a measurement of the fluid pressure inside the eye. The study doctor classified the overall improvement of the IOP change from Baseline into 3 categories: Improvement (effective), No Change or Exacerbation (ineffective). The percentage of participants with Improvement is reported. | Baseline, Week 4 |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with Open Angle Glaucoma or Ocular Hypertension treated with Combigan® Ophthalmic Solution in Clinical practice.
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Allergan | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul | South Korea |
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| ID | Title | Description |
|---|---|---|
| FG000 | Combigan® Ophthalmic Solution | Patients treated with Combigan® Ophthalmic Solution as per local standard of care in clinical practice. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Combigan® Ophthalmic Solution | Patients treated with Combigan® Ophthalmic Solution as per local standard of care in clinical practice. |
| 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 Participants Reporting Adverse Events | An adverse event was any unfavorable and unintended sign, symptom, or disease associated with the use of the study drug, whether or not considered related to the study drug. | Safety Population included all participants who received study drug. | Posted | Number | Percentage of participants | Up to 2.6 Years |
|
|
Adverse Events were assessed for up to 2.6 years
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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 | Combigan® Ophthalmic Solution | Patients treated with Combigan® Ophthalmic Solution as per local standard of care in clinical practice. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Vice President GSE, | Allergan, Inc | 714-246-4500 | clinicaltrials@allergan.com |
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| ID | Term |
|---|---|
| D005902 | Glaucoma, Open-Angle |
| D009798 | Ocular Hypertension |
| ID | Term |
|---|---|
| D005901 | Glaucoma |
| D005128 | Eye Diseases |
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| ID | Term |
|---|---|
| D000068438 | Brimonidine Tartrate |
| D000068599 | Brimonidine Tartrate, Timolol Maleate Drug Combination |
| ID | Term |
|---|---|
| D011810 | Quinoxalines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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|
| Participants |
|
| Sex/Gender, Customized | Number | Participants |
|
|
|
| Primary | Percentage of Participants With Overall Improvement From Baseline in Intraocular Pressure (IOP) | IOP is a measurement of the fluid pressure inside the eye. The study doctor classified the overall improvement of the IOP change from Baseline into 3 categories: Improvement (effective), No Change or Exacerbation (ineffective). The percentage of participants with Improvement is reported. | Efficacy Population included all participants who received study drug for > 4 weeks and had overall assessment data available. | Posted | Number | Percentage of participants | Baseline, Week 4 |
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| 0 |
| 732 |
| 0 |
| 732 |
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.
| D013999 | Timolol |
| D011412 | Propanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
| D020005 | Propanols |
| D000588 | Amines |
| D013830 | Thiadiazoles |
| D013844 | Thiazoles |
| D013457 | Sulfur Compounds |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D004338 | Drug Combinations |
| D004364 | Pharmaceutical Preparations |