Back to resultsSafety and Efficacy Study of Bimatoprost in Ethnically Japanese Patients With Open-Angle Glaucoma or Ocular Hypertension
Primary Purpose
Glaucoma, Ocular Hypertension
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Bimatoprost 0.01% Ophthalmic Solution
Bimatoprost 0.03% Ophthalmic Solution
Bimatoprost Vehicle Ophthalmic Solution
Sponsored by
About this trial
This is an interventional treatment trial for Glaucoma
Eligibility Criteria
Inclusion Criteria:
- Ethnically Japanese patients with glaucoma or ocular hypertension in each eye who require IOP-lowering therapy in both eyes
Exclusion Criteria:
- Uncontrolled systemic disease
- Use of bimatoprost or an ocular prostaglandin (eg, latanoprost, travoprost) within 6 weeks prior to baseline (Day 0)
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Placebo Comparator
Arm Label
1
2
3
Arm Description
Bimatoprost 0.01% Ophthalmic Solution
Bimatoprost 0.03% Ophthalmic Solution
Bimatoprost Vehicle Ophthalmic Solution
Outcomes
Primary Outcome Measures
Intraocular pressure (IOP)
Secondary Outcome Measures
IOP
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00651859
Brief Title
Safety and Efficacy Study of Bimatoprost in Ethnically Japanese Patients With Open-Angle Glaucoma or Ocular Hypertension
Study Type
Interventional
2. Study Status
Record Verification Date
April 2008
Overall Recruitment Status
Completed
Study Start Date
November 2002 (undefined)
Primary Completion Date
January 2004 (Actual)
Study Completion Date
January 2004 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Allergan
4. Oversight
5. Study Description
Brief Summary
This study evaluates the safety and efficacy of once-daily bimatoprost 0.03% and 0.01% ophthalmic solutions compared with once-daily administered bimatoprost vehicle ophthalmic solution for 2 weeks in ethnically Japanese patients with open-angle glaucoma or ocular hypertension
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 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
111 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
Bimatoprost 0.01% Ophthalmic Solution
Arm Title
2
Arm Type
Experimental
Arm Description
Bimatoprost 0.03% Ophthalmic Solution
Arm Title
3
Arm Type
Placebo Comparator
Arm Description
Bimatoprost Vehicle Ophthalmic Solution
Intervention Type
Drug
Intervention Name(s)
Bimatoprost 0.01% Ophthalmic Solution
Intervention Description
Bimatoprost 0.01% ophthalmic solution 1 drop instilled in each eye once daily in the evening between 19:00 and 21:00
Intervention Type
Drug
Intervention Name(s)
Bimatoprost 0.03% Ophthalmic Solution
Other Intervention Name(s)
LUMIGAN®
Intervention Description
Bimatoprost 0.03% ophthalmic solution 1 drop instilled in each eye once daily in the evening between 19:00 and 21:00
Intervention Type
Drug
Intervention Name(s)
Bimatoprost Vehicle Ophthalmic Solution
Intervention Description
Bimatoprost vehicle ophthalmic solution 1 drop instilled in each eye once daily in the evening between 19:00 and 21:00
Primary Outcome Measure Information:
Title
Intraocular pressure (IOP)
Time Frame
Day 14
Secondary Outcome Measure Information:
Title
IOP
Time Frame
Days 2 and 7
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Ethnically Japanese patients with glaucoma or ocular hypertension in each eye who require IOP-lowering therapy in both eyes
Exclusion Criteria:
Uncontrolled systemic disease
Use of bimatoprost or an ocular prostaglandin (eg, latanoprost, travoprost) within 6 weeks prior to baseline (Day 0)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Director
Organizational Affiliation
Allergan
Official's Role
Study Director
Facility Information:
City
San Francisco
State/Province
California
Country
United States
12. IPD Sharing Statement
Links:
URL
http://www.allerganclinicaltrials.com
Description
Link to Clinical Trial Results
Learn more about this trial
Safety and Efficacy Study of Bimatoprost in Ethnically Japanese Patients With Open-Angle Glaucoma or Ocular Hypertension
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