NCT00440141

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%

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Jul 2006

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2006

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

February 22, 2007

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 26, 2007

Completed
3 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2007

Completed
Last Updated

January 2, 2008

Status Verified

December 1, 2007

Enrollment Period

8 months

First QC Date

February 22, 2007

Last Update Submit

December 26, 2007

Conditions

GlaucomaOcular Hypertension

Outcome Measures

Primary Outcomes (1)

  • IOP

    Month 3

Secondary Outcomes (1)

  • Tolerability

    Month 3

Study Arms (2)

1

EXPERIMENTAL
Drug: latanoprost 0.005% eye drops and brimonidine 0.1% eye drops

2

ACTIVE COMPARATOR
Drug: latanoprost 0.005% eye drops and brinzolamide 1.0% eye drops

Interventions

latanoprost 0.005% eye drops and brimonidine 0.1% eye dropsDRUG

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

Also known as: Xalatan®, Alphagan® P
1
latanoprost 0.005% eye drops and brinzolamide 1.0% eye dropsDRUG

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

Also known as: Xalatan®, Azopt®
2

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

Atlanta, Georgia, United States

Location

Related Publications (1)

  • 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.

    PMID: 18402717DERIVED

MeSH Terms

Conditions

GlaucomaOcular Hypertension

Interventions

LatanoprostOphthalmic SolutionsBrimonidine Tartratebrinzolamide

Condition Hierarchy (Ancestors)

Eye Diseases

Intervention Hierarchy (Ancestors)

Prostaglandins F, SyntheticProstaglandins, SyntheticProstaglandinsEicosanoidsFatty Acids, UnsaturatedFatty AcidsLipidsAutacoidsInflammation MediatorsBiological FactorsPharmaceutical SolutionsSolutionsPharmaceutical PreparationsTherapeutic UsesPharmacologic ActionsChemical Actions and UsesSpecialty Uses of ChemicalsQuinoxalinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • Medical Affairs

    Allergan

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

February 22, 2007

First Posted

February 26, 2007

Study Start

July 1, 2006

Primary Completion

March 1, 2007

Study Completion

March 1, 2007

Last Updated

January 2, 2008

Record last verified: 2007-12

Locations

US(1)