24-Hour Intraocular Pressure With Brinzolamide/Timolol Versus Brimonidine/Timolol
Primary Purpose
Glaucoma
Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Brimonidine/timolol fixed combination drops added to travoprost
Brinzolamide/timolol fixed combination drops added to travoprost
Sponsored by

About this trial
This is an interventional treatment trial for Glaucoma focused on measuring 24-hour IOP control, brinzolamide/timolol, brimonidine/timolol, travoprost
Eligibility Criteria
Inclusion Criteria:
- Patient has open-angle glaucoma and is older than 29 years
- Patients should exhibit typical disc, or field changes and an untreated morning IOP greater than 25 mm Hg
- Patients are treated for at least 3 months with travoprost and should have demonstrated at least a 20% morning IOP reduction
- Patient deemed by PI to require adjunctive therapy to obtain desired target IOP
- Patient should exhibit IOP greater than 18 mm Hg on travoprost monotherapy (2 separate IOP readings at 10:00)
- Patient has mild to moderate glaucoma (field loss more than 16 dB; cupping 0.8 or less)
- Distance best corrected Snellen visual acuity at least 0.1
- No contraindications to travoprost, brimonidine, brinzolamide and β-blockers
- No history of lack of response (<10% morning IOP reduction) to any medication
- Patient can understand the instructions and adhere to medications
Exclusion Criteria:
- Female patient of childbearing potential or lactating mother
- History of trauma, inflammation, surgery
- History of past use of steroids (within 2 months), severe dry eyes and use of contact lenses
- Signs of ocular infection, except blepharitis
- Evidence of corneal abnormality that may affect IOP measurements etc
- Closed angle
- History of non-compliance
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Brinzolamide/Timolol therapy
Brimonidine/Timolol therapy
Arm Description
Chronic therapy for 3 months with brinzolamide/timolol drops given twice daily added to travoprost drops
Chronic therapy for 3 months with brimonidine/timolol drops given twice daily added to travoprost drops
Outcomes
Primary Outcome Measures
Mean 24-hour intraocular pressure
Secondary Outcome Measures
Fluctuation of 24-hour intraocular pressure
Full Information
NCT ID
NCT00981786
First Posted
September 16, 2009
Last Updated
December 16, 2020
Sponsor
Aristotle University Of Thessaloniki
Collaborators
Alcon Research
1. Study Identification
Unique Protocol Identification Number
NCT00981786
Brief Title
24-Hour Intraocular Pressure With Brinzolamide/Timolol Versus Brimonidine/Timolol
Official Title
Quality of 24-hour Intraocular Pressure Control Obtained With the Brinzolamide/Timolol Fixed Combination Compared With the Brimonidine/Timolol Fixed Combination When Added to Travoprost Monotherapy in Subjects With Open-angle Glaucoma
Study Type
Interventional
2. Study Status
Record Verification Date
December 2020
Overall Recruitment Status
Completed
Study Start Date
August 2009 (Actual)
Primary Completion Date
September 2010 (Actual)
Study Completion Date
December 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Aristotle University Of Thessaloniki
Collaborators
Alcon Research
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The proposed crossover study will compare for the first time the quality of 24-hour intraocular pressure control with the combination of travoprost and brinzolamide/timolol compared with travoprost and brimonidine/timolol in glaucoma patients insufficiently controlled with travoprost. This comparison may determine the real efficacy of the two fixed combinations when added to the prostaglandin. The design of the proposed study should facilitate a better understanding of the role of these medications in glaucoma management.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Glaucoma
Keywords
24-hour IOP control, brinzolamide/timolol, brimonidine/timolol, travoprost
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
51 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Brinzolamide/Timolol therapy
Arm Type
Active Comparator
Arm Description
Chronic therapy for 3 months with brinzolamide/timolol drops given twice daily added to travoprost drops
Arm Title
Brimonidine/Timolol therapy
Arm Type
Active Comparator
Arm Description
Chronic therapy for 3 months with brimonidine/timolol drops given twice daily added to travoprost drops
Intervention Type
Drug
Intervention Name(s)
Brimonidine/timolol fixed combination drops added to travoprost
Other Intervention Name(s)
Combigan
Intervention Description
twice daily administration
Intervention Type
Drug
Intervention Name(s)
Brinzolamide/timolol fixed combination drops added to travoprost
Other Intervention Name(s)
Azarga
Intervention Description
twice daily dosing
Primary Outcome Measure Information:
Title
Mean 24-hour intraocular pressure
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Fluctuation of 24-hour intraocular pressure
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
29 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patient has open-angle glaucoma and is older than 29 years
Patients should exhibit typical disc, or field changes and an untreated morning IOP greater than 25 mm Hg
Patients are treated for at least 3 months with travoprost and should have demonstrated at least a 20% morning IOP reduction
Patient deemed by PI to require adjunctive therapy to obtain desired target IOP
Patient should exhibit IOP greater than 18 mm Hg on travoprost monotherapy (2 separate IOP readings at 10:00)
Patient has mild to moderate glaucoma (field loss more than 16 dB; cupping 0.8 or less)
Distance best corrected Snellen visual acuity at least 0.1
No contraindications to travoprost, brimonidine, brinzolamide and β-blockers
No history of lack of response (<10% morning IOP reduction) to any medication
Patient can understand the instructions and adhere to medications
Exclusion Criteria:
Female patient of childbearing potential or lactating mother
History of trauma, inflammation, surgery
History of past use of steroids (within 2 months), severe dry eyes and use of contact lenses
Signs of ocular infection, except blepharitis
Evidence of corneal abnormality that may affect IOP measurements etc
Closed angle
History of non-compliance
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anastasios G Konstas, MD, PhD
Organizational Affiliation
Glaucoma Unit, 1st University Department of Ophthalmology
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
24-Hour Intraocular Pressure With Brinzolamide/Timolol Versus Brimonidine/Timolol
We'll reach out to this number within 24 hrs