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This study will evaluate the safety and efficacy of bimatoprost 0.01% in subjects with elevated intraocular pressure (IOP) due to primary open-angle glaucoma (POAG) or ocular hypertension (OH).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Bimatoprost 0.01% (Naive Monotherapy) | Experimental | 1 drop in the affected eye(s), administered in the evening in previously treatment naive subjects for 12 weeks. |
|
| Bimatoprost 0.01% (Switched Monotherapy) | Experimental | 1 drop in the affected eye(s), administered in the evening in subjects who were previously on another monotherapy treatment for 12 weeks. |
|
| Bimatoprost 0.01% (with Adjunctive Therapy) | Experimental | 1 drop in the affected eye(s), administered in the evening in subjects who are also receiving adjunctive therapy for 12 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bimatoprost 0.01% | Drug | 1 drop in the affected eye(s), administered in the evening for 12 weeks. |
|
| 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 participants in each severity grade are presented. | Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Intraocular Pressure (IOP) | IOP is a measure of the fluid pressure inside the eye. A negative number change from baseline indicates a reduction in IOP (improvement). | Baseline, Week 6, Week 12 |
| Overall Percent Change From Baseline in IOP |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Hyperemia Severity in the Study Eye | Hyperemia is the engorgement of the blood vessels (redness) of the eye. Hyperemia was 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). 'Lower' categories refer to grades 0, 0.5 and 1, and 'higher' categories refer to grades 2 and 3. Change in hyperemia severity was classified as improved, no change or worsened based on the change in the hyperemia grading category from higher to lower, no change in category or lower to higher, respectively. The numbers of participants in each category are presented. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Allergan | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25519810 | Derived | Park KH, Simonyi S, Kim CY, Sohn YH, Kook MS. Bimatoprost 0.01% in treatment-naive patients with open-angle glaucoma or ocular hypertension: an observational study in the Korean clinical setting. BMC Ophthalmol. 2014 Dec 17;14:160. doi: 10.1186/1471-2415-14-160. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Bimatoprost 0.01% (Naive Monotherapy) | 1 drop in the affected eye(s), administered in the evening in previously treatment naive subjects for 12 weeks. |
| FG001 | Bimatoprost 0.01% (Switched Monotherapy) | 1 drop in the affected eye(s), administered in the evening in subjects who were previously on another monotherapy treatment for 12 weeks. |
| FG002 | Bimatoprost 0.01% (With Adjunctive Therapy) | 1 drop in the affected eye(s), administered in the evening in subjects who are also receiving adjunctive therapy for 12 weeks. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Bimatoprost 0.01% (Naive Monotherapy) | 1 drop in the affected eye(s), administered in the evening in previously treatment naive subjects for 12 weeks. |
| BG001 | Bimatoprost 0.01% (Switched Monotherapy) |
| 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 | 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 participants in each severity grade are presented. | Intent to Treat: all treated subjects with data at this time point | Posted | Number | Participants | Week 12 |
|
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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% (Naive Monotherapy) | 1 drop in the affected eye(s), administered in the evening in previously treatment naive subjects for 12 weeks. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Glaucoma | Eye disorders | MedDRA version 14.1 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Conjunctival Hyperaemia | Eye disorders | MedDRA version 14.1 | 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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IOP is a measure of the fluid pressure inside the eye. A negative number change response indicates a reduction in IOP (improvement). |
| Baseline, Week 6, Week 12 |
| Baseline, Week 12 |
| Lost to Follow-up |
|
1 drop in the affected eye(s), administered in the evening in subjects who were previously on another monotherapy treatment for 12 weeks.
| BG002 | Bimatoprost 0.01% (With Adjunctive Therapy) | 1 drop in the affected eye(s), administered in the evening in subjects who are also receiving adjunctive therapy for 12 weeks. |
| BG003 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Bimatoprost 0.01% (Switched Monotherapy) |
1 drop in the affected eye(s), administered in the evening in subjects who were previously on another monotherapy treatment for 12 weeks. |
| OG002 | Bimatoprost 0.01% (With Adjunctive Therapy) | 1 drop in the affected eye(s), administered in the evening in subjects who are also receiving adjunctive therapy for 12 weeks. |
|
|
| Secondary | Change From Baseline in Intraocular Pressure (IOP) | IOP is a measure of the fluid pressure inside the eye. A negative number change from baseline indicates a reduction in IOP (improvement). | Intent to Treat: all treated subjects | Posted | Mean | Standard Deviation | Millimeters of Mercury (mmHg) | Baseline, Week 6, Week 12 |
|
|
|
| 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). | Intent to Treat: all treated subjects with data at this time point | Posted | Mean | Standard Deviation | Percent Change | Baseline, Week 6, Week 12 |
|
|
|
| Other Pre-specified | Change From Baseline in Hyperemia Severity in the Study Eye | Hyperemia is the engorgement of the blood vessels (redness) of the eye. Hyperemia was 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). 'Lower' categories refer to grades 0, 0.5 and 1, and 'higher' categories refer to grades 2 and 3. Change in hyperemia severity was classified as improved, no change or worsened based on the change in the hyperemia grading category from higher to lower, no change in category or lower to higher, respectively. The numbers of participants in each category are presented. | Intent to Treat: all treated subjects with data at this time point | Posted | Number | Participants | Baseline, Week 12 |
|
|
|
| 1 |
| 295 |
| 7 |
| 295 |
| EG001 | Bimatoprost 0.01% (Switched Monotherapy) | 1 drop in the affected eye(s), administered in the evening in subjects who were previously on another monotherapy treatment for 12 weeks. | 0 | 248 | 9 | 248 |
| EG002 | Bimatoprost 0.01% (With Adjunctive Therapy) | 1 drop in the affected eye(s), administered in the evening in subjects who are also receiving adjunctive therapy for 12 weeks. | 1 | 257 | 14 | 257 |
| Lung Neoplasm Malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 14.1 | 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 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.
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| Change from Baseline at Week 12 (N=220, 165, 191) |
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| Title | Measurements |
|---|---|
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| Worsened |
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