Back to resultsA Study of Bimatoprost in the Treatment of Primary Open Angle Glaucoma and Ocular Hypertension (LOTUS)
Primary Purpose
Glaucoma, Open-Angle, Ocular Hypertension
Status
Completed
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Bimatoprost 0.03%
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
Bimatoprost 0.03%
Arm Description
Bimatoprost 0.03% (LUMIGAN®) 1 drop in the affected eye(s) once daily as monotherapy or adjunctive therapy for 3 months.
Outcomes
Primary Outcome Measures
Intraocular Pressure (IOP) in the Study Eye
IOP is a measure of the fluid pressure inside the study eye. Patients were categorized by pre-study therapies and the bimatoprost-containing study therapy into the following 5 groups: Group A (pre-study: treatment naïve; during study: bimatoprost monotherapy); Group B (pre-study: prostaglandin analog [PGA] monotherapy, excluding bimatoprost; during study: bimatoprost monotherapy); Group C (pre-study: non-PGA monotherapy or combination therapy; during study: bimatoprost monotherapy); Group D (pre-study: combination therapy including PGA, without bimatoprost; during study: pre-study combination therapy with PGA switched to bimatoprost); and Group E (pre-study: non-PGA monotherapy or combination therapy; during study: bimatoprost adjunctive to pre-study therapy).
Secondary Outcome Measures
Percentage of Patients With an Adverse Event of Conjunctival Hyperemia
Conjunctival hyperemia is engorgement of the blood vessels (redness) of the bulbar conjunctiva of the eye (the clear membrane covering the white surface of the eye). An adverse event is any unfavorable and unintended sign, symptom, or disease associated with the use of the study drug, whether or not considered related to the study drug.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02061683
Brief Title
A Study of Bimatoprost in the Treatment of Primary Open Angle Glaucoma and Ocular Hypertension
Acronym
LOTUS
Study Type
Interventional
2. Study Status
Record Verification Date
April 2019
Overall Recruitment Status
Completed
Study Start Date
April 19, 2010 (Actual)
Primary Completion Date
June 24, 2011 (Actual)
Study Completion Date
June 24, 2011 (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 is a study of bimatoprost as initial, replacement, or adjunctive intraocular pressure (IOP)-lowering therapy in patients with 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
263 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Bimatoprost 0.03%
Arm Type
Experimental
Arm Description
Bimatoprost 0.03% (LUMIGAN®) 1 drop in the affected eye(s) once daily as monotherapy or adjunctive therapy for 3 months.
Intervention Type
Drug
Intervention Name(s)
Bimatoprost 0.03%
Other Intervention Name(s)
LUMIGAN®
Intervention Description
Bimatoprost 0.03% (LUMIGAN®) 1 drop in the affected eye(s) once daily as monotherapy or adjunctive therapy for 3 months.
Primary Outcome Measure Information:
Title
Intraocular Pressure (IOP) in the Study Eye
Description
IOP is a measure of the fluid pressure inside the study eye. Patients were categorized by pre-study therapies and the bimatoprost-containing study therapy into the following 5 groups: Group A (pre-study: treatment naïve; during study: bimatoprost monotherapy); Group B (pre-study: prostaglandin analog [PGA] monotherapy, excluding bimatoprost; during study: bimatoprost monotherapy); Group C (pre-study: non-PGA monotherapy or combination therapy; during study: bimatoprost monotherapy); Group D (pre-study: combination therapy including PGA, without bimatoprost; during study: pre-study combination therapy with PGA switched to bimatoprost); and Group E (pre-study: non-PGA monotherapy or combination therapy; during study: bimatoprost adjunctive to pre-study therapy).
Time Frame
Month 3
Secondary Outcome Measure Information:
Title
Percentage of Patients With an Adverse Event of Conjunctival Hyperemia
Description
Conjunctival hyperemia is engorgement of the blood vessels (redness) of the bulbar conjunctiva of the eye (the clear membrane covering the white surface of the eye). An adverse event is any unfavorable and unintended sign, symptom, or disease associated with the use of the study drug, whether or not considered related to the study drug.
Time Frame
3 Months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
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
Shanghai
Country
China
12. IPD Sharing Statement
Citations:
PubMed Identifier
24568617
Citation
Wang K, Xu L, Yuan Z, Yao K, Zhao J, Xu L, Fang A, Zhang M, Wu L, Ji J, Hou J, Liu Q, Sun X. Intraocular pressure-lowering efficacy and safety of bimatoprost 0.03% therapy for primary open-angle glaucoma and ocular hypertension patients in China. BMC Ophthalmol. 2014 Feb 25;14:21. doi: 10.1186/1471-2415-14-21.
Results Reference
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A Study of Bimatoprost in the Treatment of Primary Open Angle Glaucoma and Ocular Hypertension
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