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

May 6, 2008 updated by: Northwestern Ophthalmic Institute S.C.

Comparison of Brimonidine 0.15% Purite, Dorzolamide 2%, and Brinzolamide 1% as Adjunctive Therapy to Prostaglandin Analogs

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

120

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Illinois
      • Glenview, Illinois, United States, 60026
        • Northwestern Ophthalmic Institute S.C.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

41 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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 Names:
  • 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 Names:
  • 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 Names:
  • Azopt

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Intraocular pressure
Time Frame: Measurements at peak and trough effect (10 am and 4 pm) at baseline, month 1, and month 4
Measurements at peak and trough effect (10 am and 4 pm) at baseline, month 1, and month 4

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Northwestern Ophthalmic Institute S.C.

Collaborators

Research to Prevent Blindness

Investigators

  • Principal Investigator: Thomas E. Bournias, MD, Northwestern Ophthalmic Institute S.C.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2006

Primary Completion (ACTUAL)

July 1, 2007

Study Completion (ACTUAL)

July 1, 2007

Study Registration Dates

First Submitted

May 6, 2008

First Submitted That Met QC Criteria

May 6, 2008

First Posted (ESTIMATE)

May 8, 2008

Study Record Updates

Last Update Posted (ESTIMATE)

May 8, 2008

Last Update Submitted That Met QC Criteria

May 6, 2008

Last Verified

May 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NWOIADJ 2006

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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