NCT00822055

Brief Summary

This study compares the efficacy and tolerability/comfort of brimonidine/timolol and dorzolamide/timolol in patients with open-angle glaucoma or ocular hypertension. In an investigator masked randomisation process, each subject is allocated to received either brimonidine/timolol or dorzolamide/timolol as fixed-combination monotherapy or as an adjunctive to a prostaglandin analogue for a period of 12 weeks. After screening, patient returns at baseline, Month 1 and Month 3 for ophthalmic evaluations.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
140

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started May 2005

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

May 1, 2005

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2006

Completed
2.2 years until next milestone

First Submitted

Initial submission to the registry

January 13, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 14, 2009

Completed
Last Updated

January 14, 2009

Status Verified

January 1, 2009

Enrollment Period

1.5 years

First QC Date

January 13, 2009

Last Update Submit

January 13, 2009

Conditions

Open-Angle GlaucomaOcular Hypertension

Outcome Measures

Primary Outcomes (1)

  • Change from baseline in mean IOP

    12 weeks

Secondary Outcomes (1)

  • Patient tolerability/comfort measured by Likert scale

    Month 1

Study Arms (4)

1

ACTIVE COMPARATOR

brimonidine/timolol Fixed-combination monotherapy

Drug: brimonidine tartrate 0.2%/timolol maleate 0.5% fixed combination

2

ACTIVE COMPARATOR

dorzolamide/timolol fixed-combination monotherapy

Drug: dorzolamide hcl 2%/timolol maleate 0.5% fixed combination

3

ACTIVE COMPARATOR

prostaglandin analogue + brimonidine/timolol fixed combination

Drug: brimonidine tartrate 0.2%/timolol maleate 0.5% fixed combination as adjunctive to current prostaglandin therapy

4

ACTIVE COMPARATOR

prostaglandin analogue + dorzolamide/timolol fixed combination

Drug: dorzolamide hcl 2%/timolol maleate 0.5% fixed combination as adjunctive to current prostaglandin therapy

Interventions

brimonidine tartrate 0.2%/timolol maleate 0.5% fixed combinationDRUG

1 drop BID in each eye

Also known as: Combigan®
1
dorzolamide hcl 2%/timolol maleate 0.5% fixed combinationDRUG

1 drop BID in each eye

Also known as: Cosopt®
2
brimonidine tartrate 0.2%/timolol maleate 0.5% fixed combination as adjunctive to current prostaglandin therapyDRUG

1 drop BID in each eye

Also known as: Combigan®
3
dorzolamide hcl 2%/timolol maleate 0.5% fixed combination as adjunctive to current prostaglandin therapyDRUG

1 drop BID in each eye

Also known as: Cosopt®
4

Eligibility Criteria

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

You may qualify if:

  • Male or female over 18 years
  • Female subjects of childbearing potential must have negative pregnancy test and practice contraception
  • Subjects must have confirmed diagnosis of primary open-angle glaucoma or ocular hypertension in both eyes
  • Subjects who are or have been insufficiently responsive to IOP reducing monotherapy and use of either study medication is deemed appropriate
  • Subjects able to complete questionnaires and provide informed consent

You may not qualify if:

  • Female subjects who are pregnant, planning to become pregnant during study period, breast feeding or not practicing a reliable method of birth control
  • Subjects wherein the study drugs are contraindicated
  • Subjects who have had intraocular surgery with 6 months (3 months for laser)
  • Subjects with known side effects/allergy or sensitivity to any component of study treatments
  • Subjects with any uncontrolled systemic disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

Barrie, Ontario, Canada

Location

Related Publications (1)

  • Nixon DR, Yan DB, Chartrand JP, Piemontesi RL, Simonyi S, Hollander DA. Three-month, randomized, parallel-group comparison of brimonidine-timolol versus dorzolamide-timolol fixed-combination therapy. Curr Med Res Opin. 2009 Jul;25(7):1645-53. doi: 10.1185/03007990902994041.

    PMID: 19476406DERIVED

MeSH Terms

Conditions

Glaucoma, Open-AngleOcular Hypertension

Interventions

Brimonidine TartrateTimololBrimonidine Tartrate, Timolol Maleate Drug Combinationdorzolamidedorzolamide-timolol combination

Condition Hierarchy (Ancestors)

GlaucomaEye Diseases

Intervention Hierarchy (Ancestors)

QuinoxalinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsPropanolaminesAmino AlcoholsAlcoholsOrganic ChemicalsPropanolsAminesThiadiazolesThiazolesSulfur CompoundsAzolesHeterocyclic Compounds, 1-RingMorpholinesOxazinesDrug CombinationsPharmaceutical Preparations

Study Officials

  • Medical Director

    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

January 13, 2009

First Posted

January 14, 2009

Study Start

May 1, 2005

Primary Completion

November 1, 2006

Study Completion

November 1, 2006

Last Updated

January 14, 2009

Record last verified: 2009-01

Locations

CA(1)