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This is a study of bimatoprost 0.01% (LUMIGAN® 0.01%) in subjects with primary open-angle glaucoma (POAG) or ocular hypertension (OH) who require further treatment for elevated intraocular pressure (IOP).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pts with POAG or OH (Previously Treatment Naive) | Previously treatment naïve patients with Primary Open-Angle Glaucoma (POAG) or Ocular Hypertension (OH) who require treatment with bimatoprost 0.01% (Lumigan® 0.01%). |
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| Pts with POAG or OH (Switched Monotherapy) | Patients previously on another monotherapy treatment with Primary Open-Angle Glaucoma (POAG) or Ocular Hypertension (OH) who require treatment with bimatoprost 0.01% (Lumigan® 0.01%). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bimatoprost 0.01% | Drug | One drop of bimatoprost 0.01% (Lumigan® 0.01%) in the affected eye(s) every evening for 12 weeks. |
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| Measure | Description | Time Frame |
|---|---|---|
| Severity of Ocular Hyperemia in the Study Eye on a 5-Point Scale | Hyperemia is the engorgement of the blood vessels (redness) of the eye. Hyperemia is graded in the study eye on a 5-point scale where 0=None (Normal), 0.5=Trace (Trace reddish pink with no more than slight perilimbal injection), 1=Mild (Mild flush reddish color), 2=Moderate (Bright red color), and 3=Severe (Deep, bright, diffuse redness). The numbers of patients in each severity grade are presented. | 12 Weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Intraocular Pressure (IOP) in the Study Eye | IOP is a measure of the fluid pressure inside the eye. A negative number change from baseline indicates a reduction in IOP (improvement) and a positive number change from baseline indicates an increase in IOP (worsening). | Baseline, Week 12 |
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Inclusion Criteria:
Exclusion Criteria:
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Subjects 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 |
|---|---|---|---|---|---|---|
| Taichung | Taiwan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27633513 | Derived | Chen YY, Wang TH, Liu C, Wu KY, Chiu SL, Simonyi S, Lu DW. Tolerability and efficacy of bimatoprost 0.01 % in patients with open-angle glaucoma or ocular hypertension evaluated in the Taiwanese clinical setting: the Asia Pacific Patterns from Early Access of Lumigan 0.01 % (APPEAL Taiwan) study. BMC Ophthalmol. 2016 Sep 15;16(1):162. doi: 10.1186/s12886-016-0338-6. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Pts With POAG or OH (Previously Treatment Naive) | Previously treatment naïve patients with Primary Open-Angle Glaucoma (POAG) or Ocular Hypertension (OH) who require treatment with bimatoprost 0.01% (Lumigan® 0.01%). |
| FG001 | Pts With POAG or OH (Switched Monotherapy) | Patients previously on another monotherapy treatment with Primary Open-Angle Glaucoma (POAG) or Ocular Hypertension (OH) who require treatment with bimatoprost 0.01% (Lumigan® 0.01%). |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Pts With POAG or OH (Previously Treatment Naive) | Previously treatment naïve patients with Primary Open-Angle Glaucoma (POAG) or Ocular Hypertension (OH) who require treatment with bimatoprost 0.01% (Lumigan® 0.01%). |
| BG001 | Pts With POAG or OH (Switched Monotherapy) |
| 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, 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 | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Secondary | Change From Baseline in Intraocular Pressure (IOP) in the Study Eye | IOP is a measure of the fluid pressure inside the eye. A negative number change from baseline indicates a reduction in IOP (improvement) and a positive number change from baseline indicates an increase in IOP (worsening). | Intent-to-Treat: Enrolled patients who received at least one dose of study medication and who were not currently treated with Bimatoprost 0.01% at the time of enrollment | Posted | Mean | Standard Deviation | Millimeters of Mercury (mmHg) | Baseline, Week 12 |
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The Safety Population is used to assess serious adverse events (SAEs) and adverse events (AEs) and included all enrolled patients who received at least one dose of study medication and who were not currently treated with Bimatoprost 0.01% at the time of enrollment (same as the intent-to-treat population)
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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 | Pts With POAG or OH (Previously Treatment Naive) | Previously treatment naïve patients with Primary Open-Angle Glaucoma (POAG) or Ocular Hypertension (OH) who require treatment with bimatoprost 0.01% (Lumigan® 0.01%). |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Urinary Tract Infection | Infections and infestations | MedDRA version 16.0 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Ocular Hyperaemia | Eye disorders | MedDRA version 16.0 | 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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|
| Percentage of Patients Who Discontinue Due to an Adverse Event |
An adverse event is any untoward medical occurrence associated with the use of a drug, whether or not considered drug related. |
| 12 Weeks |
| Overall Percent Change From Baseline in IOP | IOP is a measure of the fluid pressure inside the eye. A negative number change response indicates a reduction in IOP (improvement) and a positive number change response indicates an increase in IOP (worsening). | Baseline, Week 12 |
| Lost to Follow-up |
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Patients previously on another monotherapy treatment with Primary Open-Angle Glaucoma (POAG) or Ocular Hypertension (OH) who require treatment with bimatoprost 0.01% (Lumigan® 0.01%). |
| BG002 | Total | Total of all reporting groups |
| Years |
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| Sex: Female, Male | Count of Participants | Participants |
|
| Pts With POAG or OH (Switched Monotherapy) |
Patients previously on another monotherapy treatment with Primary Open-Angle Glaucoma (POAG) or Ocular Hypertension (OH) who require treatment with bimatoprost 0.01% (Lumigan® 0.01%). |
|
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| Secondary | Percentage of Patients Who Discontinue Due to an Adverse Event | An adverse event is any untoward medical occurrence associated with the use of a drug, whether or not considered drug related. | Intent-to-Treat: Enrolled patients who received at least one dose of study medication and who were not currently treated with Bimatoprost 0.01% at the time of enrollment | Posted | Number | Percentage of Patients | 12 Weeks |
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| Primary | Severity of Ocular Hyperemia in the Study Eye on a 5-Point Scale | Hyperemia is the engorgement of the blood vessels (redness) of the eye. Hyperemia is graded in the study eye on a 5-point scale where 0=None (Normal), 0.5=Trace (Trace reddish pink with no more than slight perilimbal injection), 1=Mild (Mild flush reddish color), 2=Moderate (Bright red color), and 3=Severe (Deep, bright, diffuse redness). The numbers of patients in each severity grade are presented. | Intent-to-Treat: Enrolled patients who received at least one dose of study medication and who were not currently treated with Bimatoprost 0.01% at the time of enrollment | Posted | Number | Patients | 12 Weeks |
|
|
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| Secondary | Overall Percent Change From Baseline in IOP | IOP is a measure of the fluid pressure inside the eye. A negative number change response indicates a reduction in IOP (improvement) and a positive number change response indicates an increase in IOP (worsening). | Intent-to-Treat: Enrolled patients who received at least one dose of study medication and who were not currently treated with Bimatoprost 0.01% at the time of enrollment | Posted | Mean | 95% Confidence Interval | Percentage Change | Baseline, Week 12 |
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| 1 |
| 42 |
| 10 |
| 42 |
| EG001 | Pts With POAG or OH (Switched Monotherapy) | Patients previously on another monotherapy treatment with Primary Open-Angle Glaucoma (POAG) or Ocular Hypertension (OH) who require treatment with bimatoprost 0.01% (Lumigan® 0.01%). | 2 | 270 | 16 | 270 |
| Fall | Injury, poisoning and procedural complications | MedDRA version 16.0 | Non-systematic Assessment |
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| Traumatic Intracranial Haemorrhage | Injury, poisoning and procedural complications | MedDRA version 16.0 | Systematic Assessment |
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| Dry Eye | Eye disorders | MedDRA version 16.0 | 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.
| Mild |
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| Moderate |
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| Severe |
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| Missing |
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