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A Safety and Efficacy Study of Bimatoprost 0.01% in Primary Open-Angle Glaucoma (POAG) or Ocular Hypertension (OH)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Allergan
ClinicalTrials.gov Identifier:
NCT01594970
First received: May 8, 2012
Last updated: January 27, 2014
Last verified: January 2014
  Purpose
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).

Condition Intervention Phase
Glaucoma, Open-Angle Ocular Hypertension Drug: Bimatoprost 0.01% Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Allergan:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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).


Other Outcome Measures:
  • 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.


Enrollment: 800
Study Start Date: March 2012
Study Completion Date: January 2013
Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
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.
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.
Drug: Bimatoprost 0.01%
1 drop in the affected eye(s), administered in the evening for 12 weeks.
Other Name: LUMIGAN® 0.01%

  Eligibility

Ages Eligible for Study:   20 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Elevated IOP due to either primary open-angle glaucoma or ocular hypertension

Exclusion Criteria:

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01594970

Locations
Korea, Republic of
Seoul, Korea, Republic of
Sponsors and Collaborators
Allergan
Investigators
Study Director: Medical Director Allergan
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Allergan
ClinicalTrials.gov Identifier: NCT01594970     History of Changes
Other Study ID Numbers: APMA-001211
Study First Received: May 8, 2012
Results First Received: January 27, 2014
Last Updated: January 27, 2014

Additional relevant MeSH terms:
Hypertension
Glaucoma
Ocular Hypertension
Glaucoma, Open-Angle
Vascular Diseases
Cardiovascular Diseases
Eye Diseases
Bimatoprost
Antihypertensive Agents

ClinicalTrials.gov processed this record on September 20, 2017