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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01594970
Other study ID # APMA-001211
Secondary ID
Status Completed
Phase Phase 4
First received May 8, 2012
Last updated January 27, 2014
Start date March 2012
Est. completion date January 2013

Study information

Verified date January 2014
Source Allergan
Contact n/a
Is FDA regulated No
Health authority Korea: Food and Drug Administration
Study type Interventional

Clinical Trial 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).


Recruitment information / eligibility

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:

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment


Intervention

Drug:
Bimatoprost 0.01%
1 drop in the affected eye(s), administered in the evening for 12 weeks.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Allergan

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

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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