A Safety and Efficacy Study of Bimatoprost 0.01% in Primary Open-Angle Glaucoma (POAG) or Ocular Hypertension (OH)
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ClinicalTrials.gov Identifier: NCT01594970 |
Recruitment Status :
Completed
First Posted : May 9, 2012
Results First Posted : January 28, 2014
Last Update Posted : January 28, 2014
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Glaucoma, Open-Angle Ocular Hypertension | Drug: Bimatoprost 0.01% | Phase 4 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 800 participants |
Allocation: | Non-Randomized |
Intervention Model: | Single Group Assignment |
Masking: | Single (Outcomes Assessor) |
Primary Purpose: | Treatment |
Study Start Date : | March 2012 |
Actual Primary Completion Date : | January 2013 |
Actual Study Completion Date : | January 2013 |

Arm | Intervention/treatment |
---|---|
Experimental: Bimatoprost 0.01% (Naive Monotherapy)
1 drop in the affected eye(s), administered in the evening in previously treatment naive subjects for 12 weeks.
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Drug: Bimatoprost 0.01%
1 drop in the affected eye(s), administered in the evening for 12 weeks.
Other Name: LUMIGAN® 0.01% |
Experimental: Bimatoprost 0.01% (Switched Monotherapy)
1 drop in the affected eye(s), administered in the evening in subjects who were previously on another monotherapy treatment for 12 weeks.
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Drug: Bimatoprost 0.01%
1 drop in the affected eye(s), administered in the evening for 12 weeks.
Other Name: LUMIGAN® 0.01% |
Experimental: Bimatoprost 0.01% (with Adjunctive Therapy)
1 drop in the affected eye(s), administered in the evening in subjects who are also receiving adjunctive therapy for 12 weeks.
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Drug: Bimatoprost 0.01%
1 drop in the affected eye(s), administered in the evening for 12 weeks.
Other Name: LUMIGAN® 0.01% |
- Severity of Ocular Hyperemia in the Study Eye on a 5-Point Scale [ Time Frame: Week 12 ]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.
- Change From Baseline in Intraocular Pressure (IOP) [ Time Frame: Baseline, Week 6, Week 12 ]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 [ Time Frame: Baseline, Week 6, Week 12 ]IOP is a measure of the fluid pressure inside the eye. A negative number change response indicates a reduction in IOP (improvement).
- Change From Baseline in Hyperemia Severity in the Study Eye [ Time Frame: Baseline, Week 12 ]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.

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Ages Eligible for Study: | 20 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Elevated IOP due to either primary open-angle glaucoma or ocular hypertension
Exclusion Criteria:
- None

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01594970
Korea, Republic of | |
Seoul, Korea, Republic of |
Study Director: | Medical Director | Allergan |
Responsible Party: | Allergan |
ClinicalTrials.gov Identifier: | NCT01594970 |
Other Study ID Numbers: |
APMA-001211 |
First Posted: | May 9, 2012 Key Record Dates |
Results First Posted: | January 28, 2014 |
Last Update Posted: | January 28, 2014 |
Last Verified: | January 2014 |
Glaucoma Ocular Hypertension Glaucoma, Open-Angle Hypertension Vascular Diseases |
Cardiovascular Diseases Eye Diseases Bimatoprost Antihypertensive Agents |