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| ID | Type | Description | Link |
|---|---|---|---|
| AGN-EPI-2009-02 | Other Identifier | Allergan |
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This is a retrospective chart review and will assess changes in IOP after treatment with any fixed combination in patients who previously received monotherapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| POAG or OHT | Patients with POAG or OHT previously treated with monotherapy and currently treated with any fixed combination therapy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Any Fixed Combination Therapy | Drug | Patients with POAG or OHT previously treated with monotherapy and currently treated with any fixed combination therapy. This was a retrospective chart review study, so no treatment was administered in this study. |
| 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 indicates an improvement. | Baseline, 12 Weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Patient Assessment of Tolerability Using a 4-Point Scale | Patient assessment of tolerability using a 4-point scale (very good, good, moderate, and poor). The percentage of patients assessed as good and very good combined are reported. | 12 Weeks |
| Physician Assessment of Tolerability Using a 4-Point Scale |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with Primary Open Angle Glaucoma or Ocular Hypertension
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Allergan | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Madrid | Spain |
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| ID | Title | Description |
|---|---|---|
| FG000 | POAG or OHT | Patients with POAG or OHT previously treated with monotherapy and currently treated with any fixed combination therapy |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | POAG or OHT | Patients with POAG or OHT previously treated with monotherapy and currently treated with any fixed combination therapy |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Mean |
| 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 Intraocular Pressure (IOP) | IOP is a measurement of the fluid pressure inside the eye. A negative change from baseline indicates an improvement. | All patients who met the study entry criteria and have data for this outcome measure | Posted | Mean | Standard Deviation | Millimeters of Mercury (mmHg) | Baseline, 12 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 | POAG or OHT | Patients with POAG or OHT previously treated with monotherapy and currently treated with any fixed combination therapy |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Vice President Medical Affairs, | 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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Physician assessment of tolerability using a 4-point scale (very good, good, moderate, and poor). The percentage of patients assessed as good and very good combined are reported. |
| 12 Weeks |
| Percentage of Patients Who Maintained Better Compliance With Treatment | Percentage of patients who maintained better compliance with treatment than prior therapy was assessed by the patient on a 3-point scale (better, equal, and worse compliance). | 12 Weeks |
| Percentage of Patients Continuing on Therapy After 12 Weeks | Percentage of patients continuing on therapy after 12 weeks was assessed as Yes or No. | 12 Weeks |
| Years |
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| Sex/Gender, Customized | Number | Participants |
|
|
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| Secondary | Patient Assessment of Tolerability Using a 4-Point Scale | Patient assessment of tolerability using a 4-point scale (very good, good, moderate, and poor). The percentage of patients assessed as good and very good combined are reported. | All patients who met the study entry criteria and have data for this outcome measure | Posted | Number | Percentage of Patients | 12 Weeks |
|
|
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| Secondary | Physician Assessment of Tolerability Using a 4-Point Scale | Physician assessment of tolerability using a 4-point scale (very good, good, moderate, and poor). The percentage of patients assessed as good and very good combined are reported. | All patients who met the study entry criteria and have data for this outcome measure | Posted | Number | Percentage of Patients | 12 Weeks |
|
|
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| Secondary | Percentage of Patients Who Maintained Better Compliance With Treatment | Percentage of patients who maintained better compliance with treatment than prior therapy was assessed by the patient on a 3-point scale (better, equal, and worse compliance). | All patients who met the study entry criteria and have data for this outcome measure | Posted | Number | Percentage of Patients | 12 Weeks |
|
|
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| Secondary | Percentage of Patients Continuing on Therapy After 12 Weeks | Percentage of patients continuing on therapy after 12 weeks was assessed as Yes or No. | All patients who met the study entry criteria and have data for this outcome measure | Posted | Number | Percentage of Patients | 12 Weeks |
|
|
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| 4 |
| 4,385 |
| 0 |
| 4,385 |
| Keratitis | Eye disorders | Systematic Assessment |
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| Keratitis Herpetic | Eye disorders | Systematic Assessment |
|
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