Ocular Hypertension Clinical Trial
Verified date | January 2014 |
Source | Allergan |
Contact | n/a |
Is FDA regulated | No |
Health authority | Korea: Food and Drug Administration |
Study type | Interventional |
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).
Status | Completed |
Enrollment | 800 |
Est. completion date | January 2013 |
Est. primary completion date | January 2013 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 20 Years and older |
Eligibility |
Inclusion Criteria: - Elevated IOP due to either primary open-angle glaucoma or ocular hypertension Exclusion Criteria: |
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Allergan |
Korea, Republic of,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | 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. | Baseline, Week 12 | No |
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. | Week 12 | No |
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). | Baseline, Week 6, Week 12 | No |
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). | Baseline, Week 6, Week 12 | No |
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