Back to resultsStudy of Brimonidine and Timolol Ophthalmic Solution With Latanoprost Compared With Latanoprost in Glaucoma Patients
Primary Purpose
Glaucoma, Angle-Closure
Status
Terminated
Phase
Phase 4
Locations
Thailand
Study Type
Interventional
Intervention
brimonidine 0.2%/timolol 0.5% fixed combination ophthalmic solution
latanoprost
Sponsored by
About this trial
This is an interventional treatment trial for Glaucoma, Angle-Closure
Eligibility Criteria
Inclusion Criteria:
- Patient has been administering latanoprost eye drops in affected eye(s) for at least 12 weeks prior to study
- Patient must have at least partially responded to latanoprost and requiring further IOP lowering eye drops
- Diagnosis of chronic angle-closure glaucoma
- Patients using COMBIGAN® in the past must not have been discontinued due to adverse events or lack of efficacy.
Exclusion Criteria:
- Known allergy or hypersensitivity to COMBIGAN®
- Corneal abnormalities that would preclude accurate IOP readings
- Any other active ocular disease other than glaucoma or ocular hypertension
- Ocular surgery within the past 3 months.
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
COMBIGAN® with Latanoprost
Arm Description
Patients on current latanoprost monotherapy that qualify for study entry will have COMBIGAN® (brimonidine 0.2%/timolol 0.5% fixed combination ophthalmic solution) added to the latanoprost for 12 additional weeks.
Outcomes
Primary Outcome Measures
Change From Baseline in Intraocular Pressure (IOP)
IOP is a measure of the fluid pressure inside the eye. A negative number change from baseline indicates a reduction in IOP (improvement). Due to lack of enrollment, analysis was not performed for this outcome measure.
Secondary Outcome Measures
Change From Baseline in IOP
IOP is a measure of the fluid pressure inside the eye. A negative number change from baseline indicates a reduction in IOP (improvement). Due to lack of enrollment, analysis was not performed for this outcome measure.
Percentage of Responders With an IOP Reduction ≥20% From Baseline
IOP is a measure of the fluid pressure inside the eye. A responder is defined as a patient with a mean IOP reduction of at least 20% in the affected eye(s) from baseline. Due to lack of enrollment, analysis was not performed for this outcome measure.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01151904
Brief Title
Study of Brimonidine and Timolol Ophthalmic Solution With Latanoprost Compared With Latanoprost in Glaucoma Patients
Study Type
Interventional
2. Study Status
Record Verification Date
January 2013
Overall Recruitment Status
Terminated
Why Stopped
Difficulty with patient recruitment
Study Start Date
November 2009 (undefined)
Primary Completion Date
February 2012 (Actual)
Study Completion Date
February 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 the safety and efficacy of patients switched from latanoprost monotherapy to a combination therapy of latanoprost with COMBIGAN® (brimonidine 0.2%/timolol 0.5% fixed combination ophthalmic solution) for chronic angle closure glaucoma.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Glaucoma, Angle-Closure
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
17 (Actual)
8. Arms, Groups, and Interventions
Arm Title
COMBIGAN® with Latanoprost
Arm Type
Experimental
Arm Description
Patients on current latanoprost monotherapy that qualify for study entry will have COMBIGAN® (brimonidine 0.2%/timolol 0.5% fixed combination ophthalmic solution) added to the latanoprost for 12 additional weeks.
Intervention Type
Drug
Intervention Name(s)
brimonidine 0.2%/timolol 0.5% fixed combination ophthalmic solution
Other Intervention Name(s)
COMBIGAN®
Intervention Description
COMBIGAN® (brimonidine 0.2%/timolol 0.5% fixed combination ophthalmic solution) administered as one drop in the morning and one drop in the evening in affected eye(s) for 12 weeks.
Intervention Type
Drug
Intervention Name(s)
latanoprost
Intervention Description
Latanoprost administered in the affected eye(s) as prescribed by physician.
Primary Outcome Measure Information:
Title
Change From Baseline in Intraocular Pressure (IOP)
Description
IOP is a measure of the fluid pressure inside the eye. A negative number change from baseline indicates a reduction in IOP (improvement). Due to lack of enrollment, analysis was not performed for this outcome measure.
Time Frame
Baseline, Week 12
Secondary Outcome Measure Information:
Title
Change From Baseline in IOP
Description
IOP is a measure of the fluid pressure inside the eye. A negative number change from baseline indicates a reduction in IOP (improvement). Due to lack of enrollment, analysis was not performed for this outcome measure.
Time Frame
Baseline, Week 2, Week 6
Title
Percentage of Responders With an IOP Reduction ≥20% From Baseline
Description
IOP is a measure of the fluid pressure inside the eye. A responder is defined as a patient with a mean IOP reduction of at least 20% in the affected eye(s) from baseline. Due to lack of enrollment, analysis was not performed for this outcome measure.
Time Frame
Baseline, Week 12
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patient has been administering latanoprost eye drops in affected eye(s) for at least 12 weeks prior to study
Patient must have at least partially responded to latanoprost and requiring further IOP lowering eye drops
Diagnosis of chronic angle-closure glaucoma
Patients using COMBIGAN® in the past must not have been discontinued due to adverse events or lack of efficacy.
Exclusion Criteria:
Known allergy or hypersensitivity to COMBIGAN®
Corneal abnormalities that would preclude accurate IOP readings
Any other active ocular disease other than glaucoma or ocular hypertension
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
Bangkok
Country
Thailand
12. IPD Sharing Statement
Learn more about this trial
Study of Brimonidine and Timolol Ophthalmic Solution With Latanoprost Compared With Latanoprost in Glaucoma Patients
We'll reach out to this number within 24 hrs