Comparing Efficacy and Safety of Combigan With Timolol Adjunctive to Xalatan in Glaucoma or Ocular Hypertension Subjects

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

204 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-07-31

Study Completion Date

2009-12-31

Brief Summary

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Efficacy and safety evaluation of Combigan with timolol when each is used as adjunctive therapy to Xalatan in subjects with glaucoma or ocular hypertension.

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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

SINGLE

Investigators

Study Groups

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Combigan ®

Combigan® (fixed combination of brimonidine tartrate 0.2% timolol maleate 0.5%) adjunctive to Xalatan® (latanoprost 0.005%)

Group Type ACTIVE_COMPARATOR

Fixed combination of brimonidine tartrate 0.2% timolol maleate 0.5%

Intervention Type DRUG

1 drop of fixed combination of brimonidine tartrate 0.2% timolol maleate 0.5% taken approximately 12 hours apart, up to 2 times a day.

latanoprost 0.005%

Intervention Type DRUG

1 drop of latanoprost 0.005% once nightly.

Timolol Maleate 0.5%

Timolol maleate 0.5% adjunctive to Xalatan® (latanoprost 0.005%)

Group Type ACTIVE_COMPARATOR

timolol maleate 0.5%

Intervention Type DRUG

1 drop of timolol maleate 0.5% taken approximately 12 hours apart, up to 2 times a day.

latanoprost 0.005%

Intervention Type DRUG

1 drop of latanoprost 0.005% once nightly.

Interventions

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Fixed combination of brimonidine tartrate 0.2% timolol maleate 0.5%

1 drop of fixed combination of brimonidine tartrate 0.2% timolol maleate 0.5% taken approximately 12 hours apart, up to 2 times a day.

Intervention Type DRUG

timolol maleate 0.5%

1 drop of timolol maleate 0.5% taken approximately 12 hours apart, up to 2 times a day.

Intervention Type DRUG

latanoprost 0.005%

1 drop of latanoprost 0.005% once nightly.

Intervention Type DRUG

Other Intervention Names

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Combigan® Timpoptic® Timoptol® Xalatan®

Eligibility Criteria

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Inclusion Criteria

* Be at least 18 years of age
* Give written informed consent
* Be in good general health as determined by your doctor
* Have a diagnosis of unilateral or bilateral glaucoma or ocular hypertension
* If you are a female of child bearing potential, you must be willing to practice effective contraception for the duration of the study (i.e., abstinence, spermicide, condoms, or birth control pills)
* Understand the study instructions, and be able to follow the study instructions; and
* Be likely to complete the entire study period (12 weeks), including all regularly scheduled study visits

Exclusion Criteria

* Have any active ocular disease other than glaucoma or ocular hypertension that would interfere with study interpretation
* History of severe renal or hepatic impairment
* Subjects with severe cardiovascular disease should not be enrolled unless their disease is controlled and clearance has been obtained from the subject's primary care physician and/or cardiologist
* Contraindications to beta-adrenoceptor antagonist therapy such as chronic obstructive pulmonary disease, bronchial asthma, sinus bradycardia, second and third degree atrioventricular block, overt cardiac failure and cardiogenic shock or uncontrolled congestive heart failure
* Any systemic disease or clinical evidence of any condition which would make the subject, in the opinion of the investigator, unsuitable for the study or could potentially confound the study results; and
* Concurrent participation or prior participation in any investigational drug or device study within the last 30 days prior to the screening visit

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No