Back to resultsA Study of 0.03% Bimatoprost in the Treatment of Primary Open Angle Glaucoma and Ocular Hypertension (LOTUSDI)
Primary Purpose
Glaucoma, Open-Angle, Ocular Hypertension
Status
Completed
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
0.03% Bimatoprost
Sponsored by
About this trial
This is an interventional treatment trial for Glaucoma, Open-Angle
Eligibility Criteria
Inclusion Criteria:
- Diagnosis of open-angle glaucoma or ocular hypertension
- No use of Lumigan® in the past 3 months
Exclusion Criteria:
- Received laser therapy, glaucoma surgery, cataract surgery, or other ocular surgery within the past 3 months
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
0.03% Bimatoprost
Arm Description
0.03% bimatoprost (LUMIGAN®) 1 drop in the affected eye once daily in the evening as monotherapy or adjunctive therapy for 5 weeks.
Outcomes
Primary Outcome Measures
Change From Baseline in Intraocular Pressure (IOP) in the Study Eye
IOP is a measurement of the fluid pressure inside the eye. A negative number change from baseline indicates a reduction in IOP (improvement), and a positive number change from baseline indicates an increase (worsening).
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02020512
Brief Title
A Study of 0.03% Bimatoprost in the Treatment of Primary Open Angle Glaucoma and Ocular Hypertension
Acronym
LOTUSDI
Study Type
Interventional
2. Study Status
Record Verification Date
June 2014
Overall Recruitment Status
Completed
Study Start Date
July 2011 (undefined)
Primary Completion Date
December 2012 (Actual)
Study Completion Date
December 2012 (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 study will evaluate 0.03% bimatoprost in the treatment of primary open angle glaucoma and ocular hypertension.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Glaucoma, Open-Angle, Ocular Hypertension
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
87 (Actual)
8. Arms, Groups, and Interventions
Arm Title
0.03% Bimatoprost
Arm Type
Experimental
Arm Description
0.03% bimatoprost (LUMIGAN®) 1 drop in the affected eye once daily in the evening as monotherapy or adjunctive therapy for 5 weeks.
Intervention Type
Drug
Intervention Name(s)
0.03% Bimatoprost
Other Intervention Name(s)
LUMIGAN®
Intervention Description
0.03% bimatoprost (LUMIGAN®) 1 drop in the affected eye once daily in the evening as monotherapy or adjunctive therapy for 5 weeks.
Primary Outcome Measure Information:
Title
Change From Baseline in Intraocular Pressure (IOP) in the Study Eye
Description
IOP is a measurement of the fluid pressure inside the eye. A negative number change from baseline indicates a reduction in IOP (improvement), and a positive number change from baseline indicates an increase (worsening).
Time Frame
Baseline, Week 5
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Diagnosis of open-angle glaucoma or ocular hypertension
No use of Lumigan® in the past 3 months
Exclusion Criteria:
Received laser therapy, glaucoma surgery, cataract surgery, or other ocular surgery within the past 3 months
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Director
Organizational Affiliation
Allergan
Official's Role
Study Director
Facility Information:
City
Guangzhou
Country
China
12. IPD Sharing Statement
Learn more about this trial
A Study of 0.03% Bimatoprost in the Treatment of Primary Open Angle Glaucoma and Ocular Hypertension
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