Comparison of Brimonidine Purite, Dorzolamide, and Brinzolamide as Adjunctive Therapy to Prostaglandin Analogs
Information source: Northwestern Ophthalmic Institute S.C.
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Primary Open Angle Glaucoma; Ocular Hypertension
Intervention: Brimonidine purite 0.15% (Drug); Dorzolamide 2% (Drug); Brinzolamide 1% (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: Northwestern Ophthalmic Institute S.C. Official(s) and/or principal investigator(s): Thomas E. Bournias, MD, Principal Investigator, Affiliation: Northwestern Ophthalmic Institute S.C.
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.
Clinical Details
Official title: Comparison of Brimonidine 0.15% Purite, Dorzolamide 2%, and Brinzolamide 1% as Adjunctive Therapy to Prostaglandin Analogs
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment
Primary outcome: Intraocular pressure
Eligibility
Minimum age: 41 Years.
Maximum age: N/A.
Gender(s): Both.
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.
Locations and Contacts
Northwestern Ophthalmic Institute S.C., Glenview, Illinois 60026, United States
Additional Information
Starting date: January 2006
Last updated: May 6, 2008
|