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

This study has been completed.
Sponsor:
Collaborator:
Research to Prevent Blindness
Information provided by:
Northwestern Ophthalmic Institute S.C.
ClinicalTrials.gov Identifier:
NCT00675207
First received: May 6, 2008
Last updated: NA
Last verified: May 2008
History: No changes posted
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (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 ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   41 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Thomas E. Bournias, Northwestern Ophthalmic Institute S.C.
ClinicalTrials.gov Identifier: NCT00675207     History of Changes
Other Study ID Numbers: NWOIADJ 2006
Study First Received: May 6, 2008
Last Updated: May 6, 2008
Health Authority: United States: Institutional Review Board

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:
Glaucoma
Glaucoma, Open-Angle
Hypertension
Ocular Hypertension
Eye Diseases
Vascular Diseases
Cardiovascular Diseases
Carbonic Anhydrase Inhibitors
Dorzolamide
Brinzolamide
Brimonidine
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antihypertensive Agents
Cardiovascular Agents
Therapeutic Uses
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on July 31, 2014