Back to resultsComparison of Brimonidine Purite, Dorzolamide, and Brinzolamide as Adjunctive Therapy to Prostaglandin Analogs
Primary Purpose
Primary Open Angle Glaucoma, Ocular Hypertension
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Brimonidine purite 0.15%
Dorzolamide 2%
Brinzolamide 1%
Sponsored by
About this trial
This is an interventional treatment trial for Primary Open Angle Glaucoma focused on measuring glaucoma, ocular hypertension, adjunctive treatment, prostaglandin, prostaglandin analog, brimonidine, dorzolamide, brinzolamide, alpha agonist, carbonic anhydrase inhibitor, intraocular pressure
Eligibility Criteria
Inclusion Criteria:
- Diagnosis of primary open-angle glaucoma or ocular hypertension.
- Must be over 40 years of age.
- Intraocular pressure must be 18 mm Hg or higher after 6 weeks of treatment (run-in) with a prostaglandin analog (bimatoprost, latanoprost, or travoprost).
Exclusion Criteria:
- History of angle closure or narrow angle.
- Previous intraocular surgery.
- Laser trabeculoplasty within 3 months prior to screening.
- History of uveitis or intraocular inflammation.
- Use of medications other than the study medications that are known to affect IOP (e.g., beta-blockers, steroids, or angiotensin II blockers) within 3 months of study entry or during the study.
- Intolerance of or hypersensitivity to prostaglandin analogs, sulfonamides, alpha-agonists, or the preservative benzalkonium chloride.
- Women of childbearing age who are pregnant or not using contraception.
Sites / Locations
- Northwestern Ophthalmic Institute S.C.
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
Active Comparator
Arm Label
1
2
3
Arm Description
Brimonidine purite 0.15%
Dorzolamide 2%
Brinzolamide 1%
Outcomes
Primary Outcome Measures
Intraocular pressure
Secondary Outcome Measures
Full Information
NCT ID
NCT00675207
First Posted
May 6, 2008
Last Updated
May 6, 2008
Sponsor
Northwestern Ophthalmic Institute S.C.
Collaborators
Research to Prevent Blindness
1. Study Identification
Unique Protocol Identification Number
NCT00675207
Brief Title
Comparison of Brimonidine Purite, Dorzolamide, and Brinzolamide as Adjunctive Therapy to Prostaglandin Analogs
Official Title
Comparison of Brimonidine 0.15% Purite, Dorzolamide 2%, and Brinzolamide 1% as Adjunctive Therapy to Prostaglandin Analogs
Study Type
Interventional
2. Study Status
Record Verification Date
May 2008
Overall Recruitment Status
Completed
Study Start Date
January 2006 (undefined)
Primary Completion Date
July 2007 (Actual)
Study Completion Date
July 2007 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Northwestern Ophthalmic Institute S.C.
Collaborators
Research to Prevent Blindness
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of this study is to compare the efficacy of brimonidine Purite, dorzolamide, and brinzolamide in reducing intraocular pressure when added to prostaglandin analog therapy (bimatoprost, latanoprost, or travoprost) in patients with glaucoma or ocular hypertension.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Primary Open Angle Glaucoma, Ocular Hypertension
Keywords
glaucoma, ocular hypertension, adjunctive treatment, prostaglandin, prostaglandin analog, brimonidine, dorzolamide, brinzolamide, alpha agonist, carbonic anhydrase inhibitor, intraocular pressure
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
120 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Active Comparator
Arm Description
Brimonidine purite 0.15%
Arm Title
2
Arm Type
Active Comparator
Arm Description
Dorzolamide 2%
Arm Title
3
Arm Type
Active Comparator
Arm Description
Brinzolamide 1%
Intervention Type
Drug
Intervention Name(s)
Brimonidine purite 0.15%
Other Intervention Name(s)
Alphagan P 0.15%
Intervention Description
A single drop of brimonidine purite 0.15% ophthalmic solution administered topically in the eye 3 times daily.
Intervention Type
Drug
Intervention Name(s)
Dorzolamide 2%
Other Intervention Name(s)
Trusopt
Intervention Description
A single drop of dorzolamide 2% ophthalmic solution administered topically in the eye 3 times daily.
Intervention Type
Drug
Intervention Name(s)
Brinzolamide 1%
Other Intervention Name(s)
Azopt
Intervention Description
A single drop of brinzolamide 1% ophthalmic solution administered topically in the eye 3 times daily.
Primary Outcome Measure Information:
Title
Intraocular pressure
Time Frame
Measurements at peak and trough effect (10 am and 4 pm) at baseline, month 1, and month 4
10. Eligibility
Sex
All
Minimum Age & Unit of Time
41 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Diagnosis of primary open-angle glaucoma or ocular hypertension.
Must be over 40 years of age.
Intraocular pressure must be 18 mm Hg or higher after 6 weeks of treatment (run-in) with a prostaglandin analog (bimatoprost, latanoprost, or travoprost).
Exclusion Criteria:
History of angle closure or narrow angle.
Previous intraocular surgery.
Laser trabeculoplasty within 3 months prior to screening.
History of uveitis or intraocular inflammation.
Use of medications other than the study medications that are known to affect IOP (e.g., beta-blockers, steroids, or angiotensin II blockers) within 3 months of study entry or during the study.
Intolerance of or hypersensitivity to prostaglandin analogs, sulfonamides, alpha-agonists, or the preservative benzalkonium chloride.
Women of childbearing age who are pregnant or not using contraception.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thomas E. Bournias, MD
Organizational Affiliation
Northwestern Ophthalmic Institute S.C.
Official's Role
Principal Investigator
Facility Information:
Facility Name
Northwestern Ophthalmic Institute S.C.
City
Glenview
State/Province
Illinois
ZIP/Postal Code
60026
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Comparison of Brimonidine Purite, Dorzolamide, and Brinzolamide as Adjunctive Therapy to Prostaglandin Analogs
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