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

Primary Purpose

Glaucoma, Ocular Hypertension

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
latanoprost 0.005% eye drops and brimonidine 0.1% eye drops
latanoprost 0.005% eye drops and brinzolamide 1.0% eye drops
Sponsored by
Allergan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Glaucoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

1

2

Arm Description

Outcomes

Primary Outcome Measures

IOP

Secondary Outcome Measures

Tolerability

Full Information

First Posted
February 22, 2007
Last Updated
December 26, 2007
Sponsor
Allergan
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1. Study Identification

Unique Protocol Identification Number
NCT00440141
Brief Title
Brimonidine 0.1% Versus Brinzolamide 1% as Adjunctive Therapy to Latanoprost 0.005%
Study Type
Interventional

2. Study Status

Record Verification Date
December 2007
Overall Recruitment Status
Completed
Study Start Date
July 2006 (undefined)
Primary Completion Date
March 2007 (Actual)
Study Completion Date
March 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Allergan

4. Oversight

5. Study Description

Brief Summary
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%

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Glaucoma, Ocular Hypertension

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Title
2
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
latanoprost 0.005% eye drops and brimonidine 0.1% eye drops
Other Intervention Name(s)
Xalatan®, Alphagan® P
Intervention Description
latanoprost 0.005%, 1 drop nightly for 3 months and brimonidine 0.1% three-times daily for 3 months
Intervention Type
Drug
Intervention Name(s)
latanoprost 0.005% eye drops and brinzolamide 1.0% eye drops
Other Intervention Name(s)
Xalatan®, Azopt®
Intervention Description
latanoprost 0.005% 1 drop nightly for 3 months AND brinzolamide 1.0% 1% three-times daily for 3 months
Primary Outcome Measure Information:
Title
IOP
Time Frame
Month 3
Secondary Outcome Measure Information:
Title
Tolerability
Time Frame
Month 3

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Affairs
Organizational Affiliation
Allergan
Official's Role
Study Director
Facility Information:
City
Atlanta
State/Province
Georgia
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
18402717
Citation
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.
Results Reference
derived

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

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