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Assessing the Efficacy and Tolerability of AZARGA® (Brinzolamide 1%/Timolol 0.5% Fixed Combination) as Replacement Therapy in Patients on COMBIGAN® (Brimonidine 0.2%/Timolol 0.5% Fixed Combination) Therapy in Brazil

NCT ID: NCT01514734

Last Updated: 2013-10-21

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE4

Total Enrollment

9 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-03-31

Study Completion Date

2012-08-31

Brief Summary

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The purpose of this study was to assess the efficacy and tolerability of changing to AZARGA® from prior COMBIGAN® pharmacotherapy in patients with open-angle glaucoma or ocular hypertension.

Detailed Description

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Conditions

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Glaucoma

Keywords

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Primary open-angle glaucoma Ocular hypertension Pigment dispersion glaucoma

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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AZARGA

Brinzolamide/timolol maleate fixed combination, one drop self-administered in study eye(s) twice a day for 8 weeks

Group Type EXPERIMENTAL

Brinzolamide/timolol maleate fixed combination

Intervention Type DRUG

Commercially marketed topical ocular agent for the treatment of open-angle glaucoma (OAG) or ocular hypertension.

Interventions

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Brinzolamide/timolol maleate fixed combination

Commercially marketed topical ocular agent for the treatment of open-angle glaucoma (OAG) or ocular hypertension.

Intervention Type DRUG

Other Intervention Names

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AZARGA®

Eligibility Criteria

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Inclusion Criteria

* 18 years of age or older.
* Clinical diagnosis of ocular hypertension, exfoliative open-angle glaucoma, or pigment dispersion glaucoma in at least one eye (study eye).
* Be on a stable intraocular pressure (IOP) lowering regimen within 30 days of the Screening Visit.
* IOP considered safe in both eyes in such a way that should assure clinical stability of vision and optic nerve throughout the study period.
* Best corrected visual acuity of 6/60 (20/200 Snellen; 1.0 LogMAR) or better in each eye.
* IOP between 19 and 35 mmHg in at least one eye (which would be the study eye) while on brimonidine/timolol fixed combination therapy.

* History of ocular herpes simplex.
* Abnormality preventing reliable applanation tonometry.
* Corneal dystrophies.
* Concurrent infectious/noninfectious conjunctivitis, keratitis, or uveitis in either eye. Blepharitis or non-clinically significant conjunctival injection is allowed.
* Intraocular conventional surgery or laser surgery in study eye(s) less than three months prior to the Screening Visit.
* Risk of visual field or visual acuity worsening as a consequence of participation in the study, in the investigator's best judgment.
* Progressive retinal or optic nerve disease from any cause.
* Use of systemic medications known to affect IOP which have not been on a stable course for 7 days prior to the Screening Visit or an anticipated change in the dosage during the course of the study.
* Pregnant or lactating.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Alcon Research

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Doug Hubatsch, M.Sc.

Role: STUDY_DIRECTOR

Alcon Research

Locations

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São Paulo, , Brazil

Site Status

Countries

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United States Brazil

Other Identifiers

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RDG-11-191

Identifier Type: -

Identifier Source: org_study_id