Brimonidine 0.1% Versus Brinzolamide 1% as Adjunctive Therapy to Latanoprost 0.005%

NCT ID: NCT00440141

Last Updated: 2008-01-02

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

PHASE4

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-07-31

Study Completion Date

2007-03-31

Brief Summary

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Patients with glaucoma or ocular hypertension currently being treated with latanoprost 0.005%, and in need of additional IOP lowering will be randomized to receive either brimonidine 0.1% or brinzolamide 1% three-times daily as adjunctive therapy to latanoprost 0.005%

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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1

Group Type EXPERIMENTAL

latanoprost 0.005% eye drops and brimonidine 0.1% eye drops

Intervention Type DRUG

latanoprost 0.005%, 1 drop nightly for 3 months and brimonidine 0.1% three-times daily for 3 months

2

Group Type ACTIVE_COMPARATOR

latanoprost 0.005% eye drops and brinzolamide 1.0% eye drops

Intervention Type DRUG

latanoprost 0.005% 1 drop nightly for 3 months AND brinzolamide 1.0% 1% three-times daily for 3 months

Interventions

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latanoprost 0.005% eye drops and brimonidine 0.1% eye drops

latanoprost 0.005%, 1 drop nightly for 3 months and brimonidine 0.1% three-times daily for 3 months

Intervention Type DRUG

latanoprost 0.005% eye drops and brinzolamide 1.0% eye drops

latanoprost 0.005% 1 drop nightly for 3 months AND brinzolamide 1.0% 1% three-times daily for 3 months

Intervention Type DRUG

Other Intervention Names

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Xalatan® Alphagan® P Xalatan® Azopt®

Eligibility Criteria

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Inclusion Criteria

* Glaucoma or ocular hypertension in both eyes
* Currently being treated with latanoprost 0.005% QD
* IOP greater than or equal to 18mm Hg on latanoprost 0.005%
* Best-corrected VA of 20/200 or better in each eye
* Visual field within 6 months of study entry

Exclusion Criteria

* Secondary glaucoma
* Active intraocular inflammation or macular edema
* Intraocular surgery or laser surgery within the past 3 months
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 Affairs

Role: STUDY_DIRECTOR

Allergan

Locations

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Atlanta, Georgia, United States

Site Status

Countries

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United States

References

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Day DG, Hollander DA. Brimonidine purite 0.1% versus brinzolamide 1% as adjunctive therapy to latanoprost in patients with glaucoma or ocular hypertension. Curr Med Res Opin. 2008 May;24(5):1435-42. doi: 10.1185/030079908x301848. Epub 2008 Apr 9.

Reference Type DERIVED
PMID: 18402717 (View on PubMed)

Other Identifiers

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MA-AP01

Identifier Type: -

Identifier Source: org_study_id

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