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

NCT ID: NCT01229462

Last Updated: 2012-09-14

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

238 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-10-31

Study Completion Date

2011-09-30

Brief Summary

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This study will evaluate the safety and efficacy of brimonidine tartrate/timolol fixed combination (Combigan®) compared with brimonidine tartrate (Alphagan®) and timolol in patients with glaucoma or ocular hypertension who do not respond well to topical beta blockers.

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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Combigan®

One drop of brimonidine tartrate/timolol combination ophthalmic solution (Combigan®) and one drop of brimonidine tartrate/timolol fixed combination vehicle administered to the affected eye(s) twice daily (morning and evening) for four weeks.

Group Type OTHER

brimonidine tartrate/timolol fixed combination ophthalmic solution

Intervention Type DRUG

One drop of brimonidine tartrate/timolol fixed combination ophthalmic solution (Combigan®) administered to the affected eye(s) twice daily (morning and evening) for four weeks.

fixed combination vehicle

Intervention Type OTHER

Fixed combination vehicle administered to the affected eye(s) twice daily (morning and evening) for four weeks.

Alphagan® and Timolol Concurrent

One drop of brimonidine tartrate ophthalmic solution (Alphagan®) and one drop of timolol ophthalmic solution administered to the affected eye(s) twice daily (morning and evening) for four weeks.

Group Type ACTIVE_COMPARATOR

brimonidine tartrate ophthalmic solution

Intervention Type DRUG

One drop of brimonidine tartrate ophthalmic solution (Alphagan®) administered to the affected eye(s) twice daily (morning and evening) for four weeks.

timolol ophthalmic solution

Intervention Type DRUG

One drop of timolol ophthalmic solution administered to the affected eye(s) twice daily (morning and evening) for four weeks.

Interventions

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brimonidine tartrate/timolol fixed combination ophthalmic solution

One drop of brimonidine tartrate/timolol fixed combination ophthalmic solution (Combigan®) administered to the affected eye(s) twice daily (morning and evening) for four weeks.

Intervention Type DRUG

brimonidine tartrate ophthalmic solution

One drop of brimonidine tartrate ophthalmic solution (Alphagan®) administered to the affected eye(s) twice daily (morning and evening) for four weeks.

Intervention Type DRUG

timolol ophthalmic solution

One drop of timolol ophthalmic solution administered to the affected eye(s) twice daily (morning and evening) for four weeks.

Intervention Type DRUG

fixed combination vehicle

Fixed combination vehicle administered to the affected eye(s) twice daily (morning and evening) for four weeks.

Intervention Type OTHER

Other Intervention Names

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Combigan® Alphagan®

Eligibility Criteria

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Inclusion Criteria

* Open-angle glaucoma or ocular hypertension in at least one eye that is not responsive to topical beta blockers
* No anticipated wearing of contact lenses during study

Exclusion Criteria

* Active ocular disease other than glaucoma or ocular hypertension (eg, uveitis, ocular infections or severe dry eye)
* Any intraocular surgery or laser (eg, cataract surgery or Lasik) within 3 months
* Required regular use of other ocular medications except for occasional use of artificial tears
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Allergan

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Medical Director

Role: STUDY_DIRECTOR

Allergan

Locations

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Guangzhou, Guangdong, China

Site Status

Countries

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China

Other Identifiers

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190342-035

Identifier Type: -

Identifier Source: org_study_id