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Safety and Efficacy Study of Brimonidine in Patients With Glaucoma or Ocular Hypertension

NCT ID: NCT00652483

Last Updated: 2008-04-03

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

PHASE3

Total Enrollment

433 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-05-31

Study Completion Date

2004-09-30

Brief Summary

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This study evaluates the safety and efficacy of brimonidine 0.1% ophthalmic solution compared with brimonidine 0.2% ophthalmic solution in patients with glaucoma or ocular hypertension

Detailed Description

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Conditions

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Glaucoma Ocular Hypertension

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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1

Brimonidine ophthalmic solution 0.1%

Group Type EXPERIMENTAL

Brimonidine ophthalmic solution 0.1%

Intervention Type DRUG

1 drop instilled in each eye 3 times daily (08:00, 14:00, 20:00)

2

Brimonidine ophthalmic solution 0.2%

Group Type ACTIVE_COMPARATOR

Brimonidine ophthalmic solution 0.2%

Intervention Type DRUG

1 drop instilled in each eye 3 times daily (08:00, 14:00, 20:00)

Interventions

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Brimonidine ophthalmic solution 0.1%

1 drop instilled in each eye 3 times daily (08:00, 14:00, 20:00)

Intervention Type DRUG

Brimonidine ophthalmic solution 0.2%

1 drop instilled in each eye 3 times daily (08:00, 14:00, 20:00)

Intervention Type DRUG

Other Intervention Names

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ALPHAGAN®

Eligibility Criteria

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Inclusion Criteria

* Ocular hypertension or glaucoma in both eyes

Exclusion Criteria

* Uncontrolled systemic disease
* Known allergy or sensitivity to brimonidine
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Allergan

INDUSTRY

Sponsor Role lead

Responsible Party

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Allergan

Principal Investigators

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Medical Director

Role: STUDY_DIRECTOR

Allergan

Locations

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Atlanta, Georgia, United States

Site Status

Countries

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United States

Related Links

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http://www.allerganclinicaltrials.com

Link to Clinical Trial Results

Other Identifiers

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190342-021

Identifier Type: -

Identifier Source: org_study_id