Azopt (Brinzolamide 1.0%) Plus Travatan (Travoprost 0.004%) in Treating Patients With Chronic Angle-Closure Glaucoma (CACG)
Primary Purpose
Intraocular Pressure
Status
Terminated
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Travoprost 0.004% + Brinzolamide 1.0%
Travoprost 0.004% + Tears Natural
Sponsored by
About this trial
This is an interventional treatment trial for Intraocular Pressure focused on measuring IOP lowering efficacy and safety of Azopt plus Travatan
Eligibility Criteria
Inclusion Criteria:
- ≥ 18 years;
- CACG (Chronic Angle Closure Glaucoma) ≥ 1eye
- have been treated with PGA (prostaglandin analogues) once daily ≥ 2 weeks prior to the screening visit and IOP=19-32 mmHg (millimeters mercury) in at least one eye and ≤ 32 mmHg in both eyes
- clinical stability of VA (Visual Acuity) and optic nerve throughout the study
Exclusion Criteria:
- Abnormality restricts exam of the fundus or anderior chamber
- conjunctivitis, keratitis or uveitis
- unable to be discontinued from using all ocular hypotensive medication(s) except Travatan (Travoprost 0.004%) and/or Azopt (Brinzolamide 1.0%) for 12days-4weeks
- ocular surgery prior to the study
Sites / Locations
- Alcon Call Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Travoprost 0.004% + Brinzolamide 1.0%
Travoprost 0.004% + Tears Natural
Arm Description
Travoprost 0.004% (once daily) + Brinzolamide 1.0% (twice daily)
Travoprost 0.004% (once daily) + Tears Naturale (twice daily)
Outcomes
Primary Outcome Measures
Mean IOP (Intraocular Pressure)
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00758342
Brief Title
Azopt (Brinzolamide 1.0%) Plus Travatan (Travoprost 0.004%) in Treating Patients With Chronic Angle-Closure Glaucoma (CACG)
Official Title
A Double-Masked, Parallel-Group, Efficacy and Safety Study of Brinzolamide 1.0% (AZOPT) as Adjunctive Therapy to Travoprost 0.004% (TRAVATAN) in Patients With Chronic Angle-Closure Glaucoma
Study Type
Interventional
2. Study Status
Record Verification Date
February 2010
Overall Recruitment Status
Terminated
Why Stopped
difficulty of enrolling patients
Study Start Date
May 2006 (undefined)
Primary Completion Date
March 2008 (Actual)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Alcon Research
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
To evaluate the IOP (Intraocular Pressure) lowering efficacy and safety of Brinzolamide 1.0% (Azopt), dosed twice daily as adjunctive therapy in patients treated with Travoprost 0.004% (Travatan) once daily. The study is double masked. The patients will receive either treatment for 12 weeks.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Intraocular Pressure
Keywords
IOP lowering efficacy and safety of Azopt plus Travatan
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
37 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Travoprost 0.004% + Brinzolamide 1.0%
Arm Type
Experimental
Arm Description
Travoprost 0.004% (once daily) + Brinzolamide 1.0% (twice daily)
Arm Title
Travoprost 0.004% + Tears Natural
Arm Type
Active Comparator
Arm Description
Travoprost 0.004% (once daily) + Tears Naturale (twice daily)
Intervention Type
Drug
Intervention Name(s)
Travoprost 0.004% + Brinzolamide 1.0%
Intervention Description
Travoprost 0.004% (once daily) + Brinzolamide 1.0% (twice daily)
Intervention Type
Drug
Intervention Name(s)
Travoprost 0.004% + Tears Natural
Intervention Description
Travoprost 0.004% (once daily) + Tears Naturale (twice daily)
Primary Outcome Measure Information:
Title
Mean IOP (Intraocular Pressure)
Time Frame
Screening: Week 12; (At 9 am and 4 pm time points)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
≥ 18 years;
CACG (Chronic Angle Closure Glaucoma) ≥ 1eye
have been treated with PGA (prostaglandin analogues) once daily ≥ 2 weeks prior to the screening visit and IOP=19-32 mmHg (millimeters mercury) in at least one eye and ≤ 32 mmHg in both eyes
clinical stability of VA (Visual Acuity) and optic nerve throughout the study
Exclusion Criteria:
Abnormality restricts exam of the fundus or anderior chamber
conjunctivitis, keratitis or uveitis
unable to be discontinued from using all ocular hypotensive medication(s) except Travatan (Travoprost 0.004%) and/or Azopt (Brinzolamide 1.0%) for 12days-4weeks
ocular surgery prior to the study
Facility Information:
Facility Name
Alcon Call Center
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76134
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Azopt (Brinzolamide 1.0%) Plus Travatan (Travoprost 0.004%) in Treating Patients With Chronic Angle-Closure Glaucoma (CACG)
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