Back to resultsSafety and Efficacy of Triple Combination Therapy in Patients With Glaucoma or Ocular Hypertension
Primary Purpose
Glaucoma, Ocular Hypertension
Status
Completed
Phase
Phase 3
Locations
India
Study Type
Interventional
Intervention
bimatoprost/brimonidine tartrate/timolol fixed combination ophthalmic solution
Sponsored by
About this trial
This is an interventional treatment trial for Glaucoma
Eligibility Criteria
Inclusion Criteria:
- Glaucoma and/or ocular hypertension in both eyes
- Requires IOP-lowering treatment in both eyes
Exclusion Criteria:
- Other active ocular disease other than glaucoma or ocular hypertension (eg, uveitis, ocular infections or severe dry eye)
- Current or anticipated use of ocular medications other than study medications, except for intermittent use of artificial tears
- Use of oral, injectable or topical corticosteroids within 21 days
- Iridectomy or laser peripheral iridotomy in the study eye within 3 months
- Uncomplicated cataract surgery in the study eye within 6 months
- Incisional glaucoma surgery in the study eye within 12 months
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Triple Combination Therapy
Arm Description
One drop of Triple Combination Therapy (bimatoprost/brimonidine tartrate/timolol fixed combination ophthalmic solution) administered to each eye, twice daily for 12 weeks.
Outcomes
Primary Outcome Measures
Change From Baseline in Mean Diurnal Intraocular Pressure (IOP) in the Study Eye
IOP is a measurement of the fluid pressure inside the eye. Mean diurnal IOP is the mean of the IOP values at hour 0, hour 2 and hour 8 at each visit in the study eye. A negative number change from baseline indicates a reduction in IOP (improvement), and a positive number change from baseline indicates an increase in IOP (worsening).
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01216943
Brief Title
Safety and Efficacy of Triple Combination Therapy in Patients With Glaucoma or Ocular Hypertension
Official Title
A Multicenter, Open-label Study to Evaluate the Safety and Efficacy of Twice-daily 0.01% Bimatoprost/0.15% Brimonidine/0.5% Timolol Ophthalmic Solution (Triple Combination) in Patients in India, Who Have Glaucoma or Ocular Hypertension With Elevated IOP, and Are on Twice-daily 0.2% Brimonidine/0.5% Timolol Ophthalmic Solution (Dual Combination) Therapy
Study Type
Interventional
2. Study Status
Record Verification Date
July 2013
Overall Recruitment Status
Completed
Study Start Date
November 2010 (undefined)
Primary Completion Date
August 2012 (Actual)
Study Completion Date
August 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 investigate the safety and efficacy of Triple Combination Therapy (bimatoprost/brimonidine tartrate/timolol fixed combination ophthalmic solution) in patients with glaucoma or ocular hypertension who have elevated intraocular pressure (IOP) on brimonidine/timolol ophthalmic solution.
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 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
126 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Triple Combination Therapy
Arm Type
Experimental
Arm Description
One drop of Triple Combination Therapy (bimatoprost/brimonidine tartrate/timolol fixed combination ophthalmic solution) administered to each eye, twice daily for 12 weeks.
Intervention Type
Drug
Intervention Name(s)
bimatoprost/brimonidine tartrate/timolol fixed combination ophthalmic solution
Intervention Description
One drop of Triple Combination Therapy (bimatoprost/brimonidine tartrate/timolol fixed combination ophthalmic solution) administered to each eye, twice daily for 12 weeks.
Primary Outcome Measure Information:
Title
Change From Baseline in Mean Diurnal Intraocular Pressure (IOP) in the Study Eye
Description
IOP is a measurement of the fluid pressure inside the eye. Mean diurnal IOP is the mean of the IOP values at hour 0, hour 2 and hour 8 at each visit in the study eye. A negative number change from baseline indicates a reduction in IOP (improvement), and a positive number change from baseline indicates an increase in IOP (worsening).
Time Frame
Baseline, Week 12
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Glaucoma and/or ocular hypertension in both eyes
Requires IOP-lowering treatment in both eyes
Exclusion Criteria:
Other active ocular disease other than glaucoma or ocular hypertension (eg, uveitis, ocular infections or severe dry eye)
Current or anticipated use of ocular medications other than study medications, except for intermittent use of artificial tears
Use of oral, injectable or topical corticosteroids within 21 days
Iridectomy or laser peripheral iridotomy in the study eye within 3 months
Uncomplicated cataract surgery in the study eye within 6 months
Incisional glaucoma surgery in the study eye within 12 months
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Director
Organizational Affiliation
Allergan
Official's Role
Study Director
Facility Information:
City
Coimbatore
State/Province
Tamil Nadu
Country
India
12. IPD Sharing Statement
Learn more about this trial
Safety and Efficacy of Triple Combination Therapy in Patients With Glaucoma or Ocular Hypertension
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