Back to resultsA Study of LUMIGAN® RC in the Clinical Setting
Primary Purpose
Glaucoma, Primary Open Angle, Ocular Hypertension
Status
Completed
Phase
Phase 4
Locations
Canada
Study Type
Interventional
Intervention
Bimatoprost 0.01%
Sponsored by
About this trial
This is an interventional treatment trial for Glaucoma, Primary Open Angle
Eligibility Criteria
Inclusion Criteria:
- Elevated IOP due to either primary open-angle glaucoma or ocular hypertension
- Determined by the treating physician to require treatment with LUMIGAN® RC
Exclusion Criteria:
- None
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Bimatoprost 0.01%
Arm Description
Bimatoprost 0.01% (LUMIGAN® RC) administered as one drop in the study eye(s) each evening for 12 weeks.
Outcomes
Primary Outcome Measures
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.
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.
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.
Secondary Outcome Measures
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).
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).
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).
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).
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).
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).
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01833741
Brief Title
A Study of LUMIGAN® RC in the Clinical Setting
Study Type
Interventional
2. Study Status
Record Verification Date
September 2013
Overall Recruitment Status
Completed
Study Start Date
December 2009 (undefined)
Primary Completion Date
March 2011 (Actual)
Study Completion Date
March 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Allergan
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Glaucoma, Primary Open Angle, Ocular Hypertension
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
1137 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Bimatoprost 0.01%
Arm Type
Experimental
Arm Description
Bimatoprost 0.01% (LUMIGAN® RC) administered as one drop in the study eye(s) each evening for 12 weeks.
Intervention Type
Drug
Intervention Name(s)
Bimatoprost 0.01%
Other Intervention Name(s)
LUMIGAN® RC
Intervention Description
Bimatoprost 0.01% (LUMIGAN® RC) administered as one drop in the study eye(s) each evening for 12 weeks.
Primary Outcome Measure Information:
Title
Percentage of Treatment-Naive Patients With Ocular Hyperemia
Description
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.
Time Frame
Week 12
Title
Percentage of Previously Treated (Switched) Patients With Ocular Hyperemia
Description
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.
Time Frame
Week 12
Title
Percentage of Patients Treated With Adjunctive Therapy With Ocular Hyperemia
Description
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.
Time Frame
Week 12
Secondary Outcome Measure Information:
Title
Percent Change From Baseline in Intraocular Pressure (IOP) in the Study Eye of Treatment-Naive Patients
Description
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).
Time Frame
Baseline, 12 Weeks
Title
Percent Change From Baseline in IOP in the Study Eye of Previously Treated (Switched) Patients
Description
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).
Time Frame
Baseline, 12 Weeks
Title
Percent Change From Baseline in IOP in the Study Eye of Patients Treated With Adjunctive Therapy
Description
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).
Time Frame
Baseline, 12 Weeks
Title
Change From Baseline in IOP in the Study Eye of Treatment-Naive Patients
Description
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).
Time Frame
Baseline, Week 6, Week 12
Title
Change From Baseline in IOP in the Study Eye of Previously Treated (Switched) Patients
Description
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).
Time Frame
Baseline, Week 6, Week 12
Title
Change From Baseline in IOP in the Study Eye of Patients Treated With Adjunctive Therapy
Description
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).
Time Frame
Baseline, Week 6, Week 12
Title
Percentage of Patients Discontinuing Due to Ocular Adverse Events
Description
Ocular adverse events are defined as any untoward medical occurrence in a patient's eye(s) during study participation, regardless of relationship to treatment.
Time Frame
12 Weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Elevated IOP due to either primary open-angle glaucoma or ocular hypertension
Determined by the treating physician to require treatment with LUMIGAN® RC
Exclusion Criteria:
None
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Director
Organizational Affiliation
Allergan
Official's Role
Study Director
Facility Information:
City
Barrie
State/Province
Ontario
Country
Canada
12. IPD Sharing Statement
Learn more about this trial
A Study of LUMIGAN® RC in the Clinical Setting
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