NCT00981786

Brief Summary

The proposed crossover study will compare for the first time the quality of 24-hour intraocular pressure control with the combination of travoprost and brinzolamide/timolol compared with travoprost and brimonidine/timolol in glaucoma patients insufficiently controlled with travoprost. This comparison may determine the real efficacy of the two fixed combinations when added to the prostaglandin. The design of the proposed study should facilitate a better understanding of the role of these medications in glaucoma management.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
51

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Aug 2009

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2009

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

September 16, 2009

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 22, 2009

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2010

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2010

Completed
Last Updated

December 17, 2020

Status Verified

December 1, 2020

Enrollment Period

1.1 years

First QC Date

September 16, 2009

Last Update Submit

December 16, 2020

Conditions

Glaucoma

Keywords

24-hour IOP controlbrinzolamide/timololbrimonidine/timololtravoprost

Outcome Measures

Primary Outcomes (1)

  • Mean 24-hour intraocular pressure

    3 months

Secondary Outcomes (1)

  • Fluctuation of 24-hour intraocular pressure

    3 months

Study Arms (2)

Brinzolamide/Timolol therapy

ACTIVE COMPARATOR

Chronic therapy for 3 months with brinzolamide/timolol drops given twice daily added to travoprost drops

Drug: Brimonidine/timolol fixed combination drops added to travoprostDrug: Brinzolamide/timolol fixed combination drops added to travoprost

Brimonidine/Timolol therapy

ACTIVE COMPARATOR

Chronic therapy for 3 months with brimonidine/timolol drops given twice daily added to travoprost drops

Drug: Brimonidine/timolol fixed combination drops added to travoprostDrug: Brinzolamide/timolol fixed combination drops added to travoprost

Interventions

Brimonidine/timolol fixed combination drops added to travoprostDRUG

twice daily administration

Also known as: Combigan
Brimonidine/Timolol therapyBrinzolamide/Timolol therapy
Brinzolamide/timolol fixed combination drops added to travoprostDRUG

twice daily dosing

Also known as: Azarga
Brimonidine/Timolol therapyBrinzolamide/Timolol therapy

Eligibility Criteria

Age29 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patient has open-angle glaucoma and is older than 29 years
  • Patients should exhibit typical disc, or field changes and an untreated morning IOP greater than 25 mm Hg
  • Patients are treated for at least 3 months with travoprost and should have demonstrated at least a 20% morning IOP reduction
  • Patient deemed by PI to require adjunctive therapy to obtain desired target IOP
  • Patient should exhibit IOP greater than 18 mm Hg on travoprost monotherapy (2 separate IOP readings at 10:00)
  • Patient has mild to moderate glaucoma (field loss more than 16 dB; cupping 0.8 or less)
  • Distance best corrected Snellen visual acuity at least 0.1
  • No contraindications to travoprost, brimonidine, brinzolamide and β-blockers
  • No history of lack of response (\<10% morning IOP reduction) to any medication
  • Patient can understand the instructions and adhere to medications

You may not qualify if:

  • Female patient of childbearing potential or lactating mother
  • History of trauma, inflammation, surgery
  • History of past use of steroids (within 2 months), severe dry eyes and use of contact lenses
  • Signs of ocular infection, except blepharitis
  • Evidence of corneal abnormality that may affect IOP measurements etc
  • Closed angle
  • History of non-compliance

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Glaucoma

Interventions

Brimonidine TartrateBrimonidine Tartrate, Timolol Maleate Drug CombinationbrinzolamideAzarga

Condition Hierarchy (Ancestors)

Ocular HypertensionEye Diseases

Intervention Hierarchy (Ancestors)

QuinoxalinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsTimololPropanolaminesAmino AlcoholsAlcoholsOrganic ChemicalsPropanolsAminesThiadiazolesThiazolesSulfur CompoundsAzolesHeterocyclic Compounds, 1-RingDrug CombinationsPharmaceutical Preparations

Study Officials

  • Anastasios G Konstas, MD, PhD

    Glaucoma Unit, 1st University Department of Ophthalmology

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor in Ophthalmology

Study Record Dates

First Submitted

September 16, 2009

First Posted

September 22, 2009

Study Start

August 1, 2009

Primary Completion

September 1, 2010

Study Completion

December 1, 2010

Last Updated

December 17, 2020

Record last verified: 2020-12

Data Sharing

IPD Sharing
Will not share