Back to resultsA Safety Study of Bimatoprost in Patients With Glaucoma or Ocular Hypertension
Primary Purpose
Glaucoma, Ocular Hypertension
Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Bimatoprost 0.01%
Bimatoprost 0.03%
Sponsored by
About this trial
This is an interventional treatment trial for Glaucoma
Eligibility Criteria
Inclusion Criteria:
- Diagnosis of glaucoma or ocular hypertension
Exclusion Criteria:
- Active ocular disease other than glaucoma or ocular hypertension
- Require chronic use of ocular medications other than the study medication during the study (intermittent use of artificial tear solution will be permitted)
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Bimatoprost 0.01%
Bimatoprost 0.03%
Arm Description
Bimatoprost 0.01% (LUMIGAN® 0.01%) administered each evening in both eyes for 6 weeks.
Bimatoprost 0.03% (LUMIGAN® 0.03%) administered each evening in both eyes for 6 weeks.
Outcomes
Primary Outcome Measures
Percentage of Patients With an Increase in Macroscopic Conjunctival Hyperemia in Either Eye
Macroscopic conjunctival hyperemia (eye redness) is graded in each eye on a 5-point scale (Scale 0 to +3: none, trace, mild, moderate, severe). An increase (worsening) in macroscopic conjunctival hyperemia is defined as an increase in macroscopic conjunctival hyperemia grade of at least 1 from baseline in either eye.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01830140
Brief Title
A Safety Study of Bimatoprost in Patients With Glaucoma or Ocular Hypertension
Study Type
Interventional
2. Study Status
Record Verification Date
April 2015
Overall Recruitment Status
Completed
Study Start Date
July 2013 (undefined)
Primary Completion Date
May 2014 (Actual)
Study Completion Date
May 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Allergan
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
This safety study will evaluate bimatoprost 0.01% and 0.03% in patients with glaucoma or ocular hypertension (OHT).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Glaucoma, Ocular Hypertension
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
466 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Bimatoprost 0.01%
Arm Type
Experimental
Arm Description
Bimatoprost 0.01% (LUMIGAN® 0.01%) administered each evening in both eyes for 6 weeks.
Arm Title
Bimatoprost 0.03%
Arm Type
Active Comparator
Arm Description
Bimatoprost 0.03% (LUMIGAN® 0.03%) administered each evening in both eyes for 6 weeks.
Intervention Type
Drug
Intervention Name(s)
Bimatoprost 0.01%
Other Intervention Name(s)
LUMIGAN® 0.01%
Intervention Description
Bimatoprost 0.01% (LUMIGAN® 0.01%) administered each evening in both eyes for 6 weeks.
Intervention Type
Drug
Intervention Name(s)
Bimatoprost 0.03%
Other Intervention Name(s)
LUMIGAN® 0.03%
Intervention Description
Bimatoprost 0.03% (LUMIGAN® 0.03%) administered each evening in both eyes for 6 weeks.
Primary Outcome Measure Information:
Title
Percentage of Patients With an Increase in Macroscopic Conjunctival Hyperemia in Either Eye
Description
Macroscopic conjunctival hyperemia (eye redness) is graded in each eye on a 5-point scale (Scale 0 to +3: none, trace, mild, moderate, severe). An increase (worsening) in macroscopic conjunctival hyperemia is defined as an increase in macroscopic conjunctival hyperemia grade of at least 1 from baseline in either eye.
Time Frame
Baseline, 6 Weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Diagnosis of glaucoma or ocular hypertension
Exclusion Criteria:
Active ocular disease other than glaucoma or ocular hypertension
Require chronic use of ocular medications other than the study medication during the study (intermittent use of artificial tear solution will be permitted)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Director
Organizational Affiliation
Allergan
Official's Role
Study Director
Facility Information:
City
Artesia
State/Province
California
Country
United States
City
El Paso
State/Province
Texas
Country
United States
12. IPD Sharing Statement
Learn more about this trial
A Safety Study of Bimatoprost in Patients With Glaucoma or Ocular Hypertension
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