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Comparison of Brimonidine Purite, Dorzolamide, and Brinzolamide as Adjunctive Therapy to Prostaglandin Analogs

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00675207
First Posted: May 8, 2008
Last Update Posted: May 8, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Research to Prevent Blindness
Information provided by:
Northwestern Ophthalmic Institute S.C.
  Purpose
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.

Condition Intervention Phase
Primary Open Angle Glaucoma Ocular Hypertension Drug: Brimonidine purite 0.15% Drug: Dorzolamide 2% Drug: Brinzolamide 1% Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: Comparison of Brimonidine 0.15% Purite, Dorzolamide 2%, and Brinzolamide 1% as Adjunctive Therapy to Prostaglandin Analogs

Resource links provided by NLM:


Further study details as provided by Northwestern Ophthalmic Institute S.C.:

Primary Outcome Measures:
  • Intraocular pressure [ Time Frame: Measurements at peak and trough effect (10 am and 4 pm) at baseline, month 1, and month 4 ]

Enrollment: 120
Study Start Date: January 2006
Study Completion Date: July 2007
Primary Completion Date: July 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
Brimonidine purite 0.15%
Drug: Brimonidine purite 0.15%
A single drop of brimonidine purite 0.15% ophthalmic solution administered topically in the eye 3 times daily.
Other Name: Alphagan P 0.15%
Active Comparator: 2
Dorzolamide 2%
Drug: Dorzolamide 2%
A single drop of dorzolamide 2% ophthalmic solution administered topically in the eye 3 times daily.
Other Name: Trusopt
Active Comparator: 3
Brinzolamide 1%
Drug: Brinzolamide 1%
A single drop of brinzolamide 1% ophthalmic solution administered topically in the eye 3 times daily.
Other Name: Azopt

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   41 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00675207


Locations
United States, Illinois
Northwestern Ophthalmic Institute S.C.
Glenview, Illinois, United States, 60026
Sponsors and Collaborators
Northwestern Ophthalmic Institute S.C.
Research to Prevent Blindness
Investigators
Principal Investigator: Thomas E. Bournias, MD Northwestern Ophthalmic Institute S.C.
  More Information

Responsible Party: Thomas E. Bournias, Northwestern Ophthalmic Institute S.C.
ClinicalTrials.gov Identifier: NCT00675207     History of Changes
Other Study ID Numbers: NWOIADJ 2006
First Submitted: May 6, 2008
First Posted: May 8, 2008
Last Update Posted: May 8, 2008
Last Verified: May 2008

Keywords provided by Northwestern Ophthalmic Institute S.C.:
glaucoma
ocular hypertension
adjunctive treatment
prostaglandin
prostaglandin analog
brimonidine
dorzolamide
brinzolamide
alpha agonist
carbonic anhydrase inhibitor
intraocular pressure

Additional relevant MeSH terms:
Hypertension
Glaucoma
Glaucoma, Open-Angle
Ocular Hypertension
Vascular Diseases
Cardiovascular Diseases
Eye Diseases
Ophthalmic Solutions
Dorzolamide
Brimonidine Tartrate
Brinzolamide
Pharmaceutical Solutions
Antihypertensive Agents
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Carbonic Anhydrase Inhibitors
Enzyme Inhibitors