Back to resultsA Safety and Efficacy Study of Bimatoprost 0.01% in Primary Open-Angle Glaucoma (POAG) or Ocular Hypertension (OH)
Primary Purpose
Glaucoma, Open-Angle, Ocular Hypertension
Status
Completed
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Bimatoprost 0.01%
Sponsored by
About this trial
This is an interventional treatment trial for Glaucoma, Open-Angle
Eligibility Criteria
Inclusion Criteria:
- Elevated IOP due to either primary open-angle glaucoma or ocular hypertension
Exclusion Criteria:
- None
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
Bimatoprost 0.01% (Naive Monotherapy)
Bimatoprost 0.01% (Switched Monotherapy)
Bimatoprost 0.01% (with Adjunctive Therapy)
Arm Description
1 drop in the affected eye(s), administered in the evening in previously treatment naive subjects for 12 weeks.
1 drop in the affected eye(s), administered in the evening in subjects who were previously on another monotherapy treatment for 12 weeks.
1 drop in the affected eye(s), administered in the evening in subjects who are also receiving adjunctive therapy for 12 weeks.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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).
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).
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01594970
Brief Title
A Safety and Efficacy Study of Bimatoprost 0.01% in Primary Open-Angle Glaucoma (POAG) or Ocular Hypertension (OH)
Study Type
Interventional
2. Study Status
Record Verification Date
January 2014
Overall Recruitment Status
Completed
Study Start Date
March 2012 (undefined)
Primary Completion Date
January 2013 (Actual)
Study Completion Date
January 2013 (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 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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Glaucoma, Open-Angle, Ocular Hypertension
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
Outcomes Assessor
Allocation
Non-Randomized
Enrollment
800 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Bimatoprost 0.01% (Naive Monotherapy)
Arm Type
Experimental
Arm Description
1 drop in the affected eye(s), administered in the evening in previously treatment naive subjects for 12 weeks.
Arm Title
Bimatoprost 0.01% (Switched Monotherapy)
Arm Type
Experimental
Arm Description
1 drop in the affected eye(s), administered in the evening in subjects who were previously on another monotherapy treatment for 12 weeks.
Arm Title
Bimatoprost 0.01% (with Adjunctive Therapy)
Arm Type
Experimental
Arm Description
1 drop in the affected eye(s), administered in the evening in subjects who are also receiving adjunctive therapy for 12 weeks.
Intervention Type
Drug
Intervention Name(s)
Bimatoprost 0.01%
Other Intervention Name(s)
LUMIGAN® 0.01%
Intervention Description
1 drop in the affected eye(s), administered in the evening for 12 weeks.
Primary Outcome Measure Information:
Title
Severity of Ocular Hyperemia in the Study Eye on a 5-Point Scale
Description
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.
Time Frame
Week 12
Secondary Outcome Measure Information:
Title
Change From Baseline in Intraocular Pressure (IOP)
Description
IOP is a measure of the fluid pressure inside the eye. A negative number change from baseline indicates a reduction in IOP (improvement).
Time Frame
Baseline, Week 6, Week 12
Title
Overall Percent Change From Baseline in IOP
Description
IOP is a measure of the fluid pressure inside the eye. A negative number change response indicates a reduction in IOP (improvement).
Time Frame
Baseline, Week 6, Week 12
Other Pre-specified Outcome Measures:
Title
Change From Baseline in Hyperemia Severity in the Study Eye
Description
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.
Time Frame
Baseline, Week 12
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Elevated IOP due to either primary open-angle glaucoma or ocular hypertension
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
Seoul
Country
Korea, Republic of
12. IPD Sharing Statement
Citations:
PubMed Identifier
25519810
Citation
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.
Results Reference
derived
Learn more about this trial
A Safety and Efficacy Study of Bimatoprost 0.01% in Primary Open-Angle Glaucoma (POAG) or Ocular Hypertension (OH)
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