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

May 8, 2012
January 27, 2014
March 2012
January 2013   (final data collection date for primary outcome measure)
Severity of Ocular Hyperemia in the Study Eye on a 5-Point Scale [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
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.
Number of Subjects with Ocular Hyperaemia [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01594970 on ClinicalTrials.gov Archive Site
  • Change From Baseline in Intraocular Pressure (IOP) [ Time Frame: Baseline, Week 6, Week 12 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 IOP [ Time Frame: Baseline, Week 6 ] [ Designated as safety issue: No ]
  • Percentage Change from Baseline in IOP [ Time Frame: Baseline, Week 12 ] [ Designated as safety issue: No ]
  • Change from Baseline in IOP [ Time Frame: Baseline, Week 12 ] [ Designated as safety issue: No ]
Change From Baseline in Hyperemia Severity in the Study Eye [ Time Frame: Baseline, Week 12 ] [ Designated as safety issue: No ]
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.
Not Provided
 
A Safety and Efficacy Study of Bimatoprost 0.01% in Primary Open-Angle Glaucoma (POAG) or Ocular Hypertension (OH)
Not Provided

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).

Not Provided
Interventional
Phase 4
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
  • Glaucoma, Open-Angle
  • Ocular Hypertension
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% (Naive Monotherapy)
    1 drop in the affected eye(s), administered in the evening in previously treatment naive subjects for 12 weeks.
    Intervention: Drug: Bimatoprost 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.
    Intervention: Drug: Bimatoprost 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.
    Intervention: Drug: Bimatoprost 0.01%
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
800
January 2013
January 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

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

Exclusion Criteria:

  • None
Both
20 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Korea, Republic of
 
NCT01594970
APMA-001211
No
Allergan
Allergan
Not Provided
Study Director: Medical Director Allergan
Allergan
January 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP