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This study is a Post-Marketing Surveillance study to evaluate the safety and efficacy of bimatoprost/timolol (Ganfort®) Ophthalmic Solution to treat open-angle glaucoma or ocular hypertension in Korea.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ganfort® | Patients who received treatment with bimatoprost/timolol (Ganfort®) for open-angle glaucoma or ocular hypertension as per local standard of care in clinical practice. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| bimatoprost/timolol | Drug | Bimatoprost/timolol (Ganfort®) treatment for open-angle glaucoma or ocular hypertension as per local standard of care in clinical practice. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Adverse Events and Adverse Drug Reactions | An Adverse Event was considered 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. An Adverse Drug Reaction was a harmful and unintended reaction that is incurred during routine administration or use of the drug, whose causal relationship with the drug cannot be excluded. | Up to 51 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Intraocular Pressure (IOP) | IOP is a measurement of the fluid pressure inside the eye. A negative change from Baseline indicated an improvement. The median total treatment duration for participants was 63.0 days. | Baseline, Week 4 |
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Inclusion Criteria:
Exclusion Criteria:
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Patients treated with Ganfort® for open-angle glaucoma or ocular hypertension 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 | Ganfort® | Patients who received treatment with bimatoprost/timolol (Ganfort®) for open-angle glaucoma or ocular hypertension as per local standard of care in clinical practice. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Safety population included all participants treated for on-label indications.
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| ID | Title | Description |
|---|---|---|
| BG000 | Ganfort® | Patients who received treatment with bimatoprost/timolol (Ganfort®) for open-angle glaucoma or ocular hypertension 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 | Number of Participants With Adverse Events and Adverse Drug Reactions | An Adverse Event was considered 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. An Adverse Drug Reaction was a harmful and unintended reaction that is incurred during routine administration or use of the drug, whose causal relationship with the drug cannot be excluded. | Safety population included all participants treated for on-label indications. | Posted | Number | participants | Up to 51 months |
|
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The Safety Population, all participants treated for on-label indications, was used to determine the number of participants at risk for Serious Adverse Events and Adverse Events.
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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 | Ganfort® | Patients who received treatment with bimatoprost/timolol (Ganfort®) for open-angle glaucoma or ocular hypertension as per local standard of care in clinical practice. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Neoplasm metastatic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (11.1) | Systematic Assessment | Investigator determined not-related to study medication. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Conjunctival hyperaemia | Eye disorders | MedDRA (11.1) | Systematic Assessment |
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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 |
|---|---|
| D000069580 | Bimatoprost |
| D013999 | Timolol |
| C571755 | Ganfort |
| ID | Term |
|---|---|
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D003008 | Cloprostenol |
| D011461 | Prostaglandins F, Synthetic |
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|
| participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Secondary | Change From Baseline in Intraocular Pressure (IOP) | IOP is a measurement of the fluid pressure inside the eye. A negative change from Baseline indicated an improvement. The median total treatment duration for participants was 63.0 days. | Efficacy population included all participants who were treated for on-label indications with data available for analysis. | Posted | Mean | Standard Deviation | mmHg | Baseline, Week 4 |
|
|
|
| 1 |
| 742 |
| 86 |
| 742 |
|
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 at least 30 days from the time submitted to the sponsor for review. The sponsor cannot require changes to the communication and cannot extend the embargo.
| D011465 |
| Prostaglandins, Synthetic |
| D011453 | Prostaglandins |
| D015777 | Eicosanoids |
| D005231 | Fatty Acids, Unsaturated |
| D005227 | Fatty Acids |
| D008055 | Lipids |
| D012898 | Autacoids |
| D018836 | Inflammation Mediators |
| D001685 | Biological Factors |
| D011412 | Propanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D020005 | Propanols |
| D000588 | Amines |
| D013830 | Thiadiazoles |
| D013844 | Thiazoles |
| D013457 | Sulfur Compounds |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D009025 | Morpholines |
| D010078 | Oxazines |
|
| Left Eye: Change from Baseline (n=616) |
|