Back to resultsSafety and Efficacy Study of Bimatoprost in Patients With Glaucoma or Ocular Hypertension
Primary Purpose
Ocular Hypertension
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
bimatoprost
Sponsored by
About this trial
This is an interventional treatment trial for Ocular Hypertension
Eligibility Criteria
Inclusion Criteria: Clinical diagnosis of glaucoma or ocular hypertension in both eyes Patient requires IOP-lowering drug in both eyes Exclusion Criteria: Uncontrolled medical conditions Ocular seasonal allergies within the past 2 years
Sites / Locations
Outcomes
Primary Outcome Measures
Lowering intraocular pressure (IOP)
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00300443
Brief Title
Safety and Efficacy Study of Bimatoprost in Patients With Glaucoma or Ocular Hypertension
Study Type
Interventional
2. Study Status
Record Verification Date
May 2011
Overall Recruitment Status
Completed
Study Start Date
December 2005 (undefined)
Primary Completion Date
June 2007 (Actual)
Study Completion Date
June 2007 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Allergan
4. Oversight
5. Study Description
Brief Summary
The purpose of this study is to assess the safety and efficacy of bimatoprost in patients with glaucoma or ocular hypertension
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ocular Hypertension
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
561 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
bimatoprost
Primary Outcome Measure Information:
Title
Lowering intraocular pressure (IOP)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Clinical diagnosis of glaucoma or ocular hypertension in both eyes
Patient requires IOP-lowering drug in both eyes
Exclusion Criteria:
Uncontrolled medical conditions
Ocular seasonal allergies within the past 2 years
Facility Information:
City
Newport Beach
State/Province
California
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
20346780
Citation
Katz LJ, Cohen JS, Batoosingh AL, Felix C, Shu V, Schiffman RM. Twelve-month, randomized, controlled trial of bimatoprost 0.01%, 0.0125%, and 0.03% in patients with glaucoma or ocular hypertension. Am J Ophthalmol. 2010 Apr;149(4):661-671.e1. doi: 10.1016/j.ajo.2009.12.003.
Results Reference
derived
Learn more about this trial
Safety and Efficacy Study of Bimatoprost in Patients With Glaucoma or Ocular Hypertension
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