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Safety and Efficacy Study of Brimonidine/Timolol Fixed Combination in Patients With Glaucoma or Ocular Hypertension

NCT ID: NCT00652106

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

432 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-06-30

Study Completion Date

2004-03-31

Brief Summary

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This study evaluates the safety and efficacy of brimonidine 0.2%/timolol 0.5% fixed combination ophthalmic solution compared with concurrent brimonidine 0.2% and timolol ophthalmic solutions

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

0.2% brimonidine/0.5% timolol fixed combination ophthalmic solution

Group Type EXPERIMENTAL

0.2% brimonidine/0.5% timolol fixed combination ophthalmic solution

Intervention Type DRUG

0.2% brimonidine/0.5% timolol fixed combination ophthalmic solution 1 drop instilled in each eye twice daily (morning and evening)

2

Concurrent brimonidine 0.2% and Timolol 0.5% ophthalmic solution

Group Type ACTIVE_COMPARATOR

Concurrent brimonidine 0.2% and Timolol 0.5% ophthalmic solution

Intervention Type DRUG

Brimonidine 0.2% 1 drop instilled in each eye three times daily (morning, afternoon, and evening) and concurrent timolol 0.5% ophthalmic solution 1 drop instilled in each eye twice daily (morning and evening)

3

0.2% brimonidine ophthalmic solution

Group Type ACTIVE_COMPARATOR

Brimonidine 0.2% ophthalmic solution

Intervention Type DRUG

Brimonidine 0.2% ophthalmic solution 1 drop instilled in each eye three times daily (morning, afternoon, and evening)

Interventions

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0.2% brimonidine/0.5% timolol fixed combination ophthalmic solution

0.2% brimonidine/0.5% timolol fixed combination ophthalmic solution 1 drop instilled in each eye twice daily (morning and evening)

Intervention Type DRUG

Concurrent brimonidine 0.2% and Timolol 0.5% ophthalmic solution

Brimonidine 0.2% 1 drop instilled in each eye three times daily (morning, afternoon, and evening) and concurrent timolol 0.5% ophthalmic solution 1 drop instilled in each eye twice daily (morning and evening)

Intervention Type DRUG

Brimonidine 0.2% ophthalmic solution

Brimonidine 0.2% ophthalmic solution 1 drop instilled in each eye three times daily (morning, afternoon, and evening)

Intervention Type DRUG

Other Intervention Names

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COMBIGAN® ALPHAGAN®

Eligibility Criteria

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Inclusion Criteria

* Diagnosis of ocular hypertension or glaucoma
* Patient requires IOP-lowering therapy in both eyes

Exclusion Criteria

* Uncontrolled medical conditions
* Contraindication to β-adrenoceptor antagonist therapy or brimonidine therapy
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, Inc.

Principal Investigators

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Medical Director

Role: STUDY_DIRECTOR

Allergan

Locations

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El Paso, Texas, 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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190342-019T

Identifier Type: -

Identifier Source: org_study_id