Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This study will evaluate bimatoprost 0.01% (LUMIGAN® RC) in patients with elevated intraocular pressure (IOP) due to primary open angle glaucoma (POAG) or ocular hypertension (OHT) in a clinical setting.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Bimatoprost 0.01% | Experimental | Bimatoprost 0.01% (LUMIGAN® RC) administered as one drop in the study eye(s) each evening for 12 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bimatoprost 0.01% | Drug | Bimatoprost 0.01% (LUMIGAN® RC) administered as one drop in the study eye(s) each evening for 12 weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Treatment-Naive Patients With Ocular Hyperemia | Hyperemia is engorgement of the blood vessels (redness) of the bulbar conjunctiva of the eye (the clear membrane covering the white surface of the eye). Hyperemia is graded on a 5 point scale where 0=none (normal), 0.5=trace (trace flush reddish pink), 1=Mild (mild flush reddish color), 2=Moderate (bright red color) and 3=severe (deep bright diffuse redness). Naive patients did not use glaucoma medication prior to study entry. | Week 12 |
| Percentage of Previously Treated (Switched) Patients With Ocular Hyperemia | Hyperemia is engorgement of the blood vessels (redness) of the bulbar conjunctiva of the eye (the clear membrane covering the white surface of the eye). Hyperemia is graded on a 5 point scale where 0=none (normal), 0.5=trace (trace flush reddish pink), 1=Mild (mild flush reddish color), 2=Moderate (bright red color) and 3=severe (deep bright diffuse redness). Previously treated patients used glaucoma medication prior to study entry and were switched from their previous therapy to study treatment. | Week 12 |
| Percentage of Patients Treated With Adjunctive Therapy With Ocular Hyperemia | Hyperemia is engorgement of the blood vessels (redness) of the bulbar conjunctiva of the eye (the clear membrane covering the white surface of the eye). Hyperemia is graded on a 5 point scale where 0=none (normal), 0.5=trace (trace flush reddish pink), 1=Mild (mild flush reddish color), 2=Moderate (bright red color) and 3=severe (deep bright diffuse redness). Previously treated patients used glaucoma medication prior to study entry and added study treatment as adjunctive therapy. | Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Percent Change From Baseline in Intraocular Pressure (IOP) in the Study Eye of Treatment-Naive Patients | IOP is a measurement of the fluid pressure inside the eye. Naive patients did not use glaucoma medication prior to study entry. A negative number change from baseline indicates a reduction in IOP (improvement), and a positive number change from baseline indicates an increase (worsening). | Baseline, 12 Weeks |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Allergan | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Barrie | Ontario | Canada |
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Bimatoprost 0.01% | Bimatoprost 0.01% (LUMIGAN® RC) administered as one drop in the study eye(s) each evening for 12 weeks. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Bimatoprost 0.01% | Bimatoprost 0.01% (LUMIGAN® RC) administered as one drop in the study eye(s) each evening for 12 weeks. |
| 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 | Percentage of Treatment-Naive Patients With Ocular Hyperemia | Hyperemia is engorgement of the blood vessels (redness) of the bulbar conjunctiva of the eye (the clear membrane covering the white surface of the eye). Hyperemia is graded on a 5 point scale where 0=none (normal), 0.5=trace (trace flush reddish pink), 1=Mild (mild flush reddish color), 2=Moderate (bright red color) and 3=severe (deep bright diffuse redness). Naive patients did not use glaucoma medication prior to study entry. | All patients who were consented and completed the Baseline visit, and who had data for Week 12 | Posted | Number | Percentage of Patients | Week 12 |
|
Not provided
Not provided
Not provided
| 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% | Bimatoprost 0.01% (LUMIGAN® RC) administered as one drop in the study eye(s) each evening for 12 weeks. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cerebrovascular Accident | Cardiac disorders | MedDRA version 14.0 | Systematic Assessment |
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Vice President Medical Affairs, | Allergan, Inc | 714-246-4500 | clinicaltrials@allergan.com |
Not provided
| ID | Term |
|---|---|
| D005902 | Glaucoma, Open-Angle |
| D009798 | Ocular Hypertension |
| ID | Term |
|---|---|
| D005901 | Glaucoma |
| D005128 | Eye Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Percent Change From Baseline in IOP in the Study Eye of Previously Treated (Switched) Patients | IOP is a measurement of the fluid pressure inside the eye. Previously treated patients used glaucoma medication prior to study entry and were switched from their previous therapy to study treatment. A negative number change from baseline indicates a reduction in IOP (improvement), and a positive number change from baseline indicates an increase (worsening). | Baseline, 12 Weeks |
| Percent Change From Baseline in IOP in the Study Eye of Patients Treated With Adjunctive Therapy | IOP is a measurement of the fluid pressure inside the eye. Previously treated patients used glaucoma medication prior to study entry and added study treatment as adjunctive therapy. A negative number change from baseline indicates a reduction in IOP (improvement), and a positive number change from baseline indicates an increase (worsening). | Baseline, 12 Weeks |
| Change From Baseline in IOP in the Study Eye of Treatment-Naive Patients | IOP is a measurement 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 (worsening). | Baseline, Week 6, Week 12 |
| Change From Baseline in IOP in the Study Eye of Previously Treated (Switched) Patients | IOP is a measurement 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 (worsening). | Baseline, Week 6, Week 12 |
| Change From Baseline in IOP in the Study Eye of Patients Treated With Adjunctive Therapy | IOP is a measurement 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 (worsening). | Baseline, Week 6, Week 12 |
| Percentage of Patients Discontinuing Due to Ocular Adverse Events | Ocular adverse events are defined as any untoward medical occurrence in a patient's eye(s) during study participation, regardless of relationship to treatment. | 12 Weeks |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Secondary | Percent Change From Baseline in Intraocular Pressure (IOP) in the Study Eye of Treatment-Naive Patients | IOP is a measurement of the fluid pressure inside the eye. Naive patients did not use glaucoma medication prior to study entry. A negative number change from baseline indicates a reduction in IOP (improvement), and a positive number change from baseline indicates an increase (worsening). | Intent to Treat: all patients who were consented and completed the Baseline visit | Posted | Mean | Standard Deviation | Percent Change | Baseline, 12 Weeks |
|
|
|
| Secondary | Percent Change From Baseline in IOP in the Study Eye of Previously Treated (Switched) Patients | IOP is a measurement of the fluid pressure inside the eye. Previously treated patients used glaucoma medication prior to study entry and were switched from their previous therapy to study treatment. A negative number change from baseline indicates a reduction in IOP (improvement), and a positive number change from baseline indicates an increase (worsening). | Intent to Treat: all patients who were consented and completed the Baseline visit | Posted | Mean | Standard Deviation | Percent Change | Baseline, 12 Weeks |
|
|
|
| Secondary | Percent Change From Baseline in IOP in the Study Eye of Patients Treated With Adjunctive Therapy | IOP is a measurement of the fluid pressure inside the eye. Previously treated patients used glaucoma medication prior to study entry and added study treatment as adjunctive therapy. A negative number change from baseline indicates a reduction in IOP (improvement), and a positive number change from baseline indicates an increase (worsening). | Intent to Treat: all patients who were consented and completed the Baseline visit | Posted | Mean | Standard Deviation | Percent Change | Baseline, 12 Weeks |
|
|
|
| Secondary | Change From Baseline in IOP in the Study Eye of Treatment-Naive Patients | IOP is a measurement 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 (worsening). | Intent to Treat: all patients who were consented and completed the Baseline visit | Posted | Mean | Standard Deviation | Millimeters of Mercury (mmHg) | Baseline, Week 6, Week 12 |
|
|
|
| Secondary | Change From Baseline in IOP in the Study Eye of Previously Treated (Switched) Patients | IOP is a measurement 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 (worsening). | Intent to Treat: all patients who were consented and completed the Baseline visit | Posted | Mean | Standard Deviation | Millimeters of Mercury (mmHg) | Baseline, Week 6, Week 12 |
|
|
|
| Secondary | Change From Baseline in IOP in the Study Eye of Patients Treated With Adjunctive Therapy | IOP is a measurement 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 (worsening). | Intent to Treat: all patients who were consented and completed the Baseline visit | Posted | Mean | Standard Deviation | Millimeters of Mercury (mmHg) | Baseline, Week 6, Week 12 |
|
|
|
| Secondary | Percentage of Patients Discontinuing Due to Ocular Adverse Events | Ocular adverse events are defined as any untoward medical occurrence in a patient's eye(s) during study participation, regardless of relationship to treatment. | Intent to Treat: all patients who were consented and completed the Baseline visit | Posted | Number | Percentage of Patients | 12 Weeks |
|
|
|
| Primary | Percentage of Previously Treated (Switched) Patients With Ocular Hyperemia | Hyperemia is engorgement of the blood vessels (redness) of the bulbar conjunctiva of the eye (the clear membrane covering the white surface of the eye). Hyperemia is graded on a 5 point scale where 0=none (normal), 0.5=trace (trace flush reddish pink), 1=Mild (mild flush reddish color), 2=Moderate (bright red color) and 3=severe (deep bright diffuse redness). Previously treated patients used glaucoma medication prior to study entry and were switched from their previous therapy to study treatment. | All patients who were consented and completed the Baseline visit, and who had data for Week 12 | Posted | Number | Percentage of Patients | Week 12 |
|
|
|
| Primary | Percentage of Patients Treated With Adjunctive Therapy With Ocular Hyperemia | Hyperemia is engorgement of the blood vessels (redness) of the bulbar conjunctiva of the eye (the clear membrane covering the white surface of the eye). Hyperemia is graded on a 5 point scale where 0=none (normal), 0.5=trace (trace flush reddish pink), 1=Mild (mild flush reddish color), 2=Moderate (bright red color) and 3=severe (deep bright diffuse redness). Previously treated patients used glaucoma medication prior to study entry and added study treatment as adjunctive therapy. | All patients who were consented and completed the Baseline visit, and who had data for Week 12 | Posted | Number | Percentage of Patients | Week 12 |
|
|
|
| 3 |
| 1,137 |
| 0 |
| 1,137 |
| Malaise | General disorders | MedDRA version 14.0 | Non-systematic Assessment |
|
| Myocardial Infarction | Cardiac disorders | MedDRA version 14.0 | Systematic Assessment |
|
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.
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| +2 (moderate) |
|
| +3 (severe) |
|
| Title | Measurements |
|---|---|
|
| +2 (moderate) |
|
| +3 (severe) |
|