Brimonidine Purite 0.15% Versus Dorzolamide 2% Used as Adjunctive Therapy to Latanoprost

NCT ID: NCT00348400

Last Updated: 2007-06-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Study Classification

INTERVENTIONAL

Brief Summary

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Evaluate the relative efficacy and tolerability of Alphagan P compared to Trusopt as adjunctive therapy

Detailed Description

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Conditions

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Glaucoma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

SINGLE

Interventions

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Brimonidine Purite 0.15%, Dorzolamide 2%, Latanoprost

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* · Male or female \> 18 years of age

* Diagnosis of open-angle glaucoma or ocular hypertension
* IOP \> 16 mm Hg in each eye at the latanoprost -treated baseline evaluation
* Presently on latanoprost monotherapy for at least 6 weeks
* Ability to provide informed consent and likely to complete all study visits

Exclusion Criteria

* · Known contraindication or allergy to brimonidine or any of its components

* Subjects must be naive to brimonidine 0.2% or brimonidine Purite 0.15% and dorzolamide 2%
* Uncontrolled systemic disease
* Active ocular disease other than glaucoma or ocular hypertension (e.g. uveitis, ocular infections, or severe dry eye). Patients with chronic mild blepharitis, cataract, age-related macular degeneration, or background diabetic retinopathy may be enrolled at the discretion of the investigator.
* Required use of ocular medications other than the study medications during the study (intermittent use of artificial tear product is allowed).
* Corneal abnormalities
* History of intraocular surgery within the last 3 months
* Female patients of childbearing potential who are pregnant, lactating, planning a pregnancy, or not using a reliable form of birth control
* Visual field loss, which in the opinion of the investigator, is functionally significant, or evidence of progressive visual field loss within the last year.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Innovative Medical

INDUSTRY

Sponsor Role lead

Principal Investigators

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Robert Noecker, MD

Role: PRINCIPAL_INVESTIGATOR

UPMC Eye Center

Locations

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Dr. Noecker

Pittsburgh, Pennsylvania, United States

Site Status

Countries

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United States

Other Identifiers

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5099

Identifier Type: -

Identifier Source: org_study_id