NCT00972257

Brief Summary

The proposed study will compare for the first time the quality of 24-hour IOP control with Brimonidine/Timolol fixed combination (BTFC) versus Dorzolamide/Timolol fixed combination (DTFC) after a run-in period of 2 months with timolol. This crossover comparison may determine the real efficacy of the two fixed combinations and the design of the proposed study may explain for the first time why the 24-hour IOP reduction provided by BTFC is less than might be anticipated.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
64

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Jan 2009

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2009

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2009

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

September 3, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 4, 2009

Completed
Last Updated

May 12, 2014

Status Verified

May 1, 2014

Enrollment Period

8 months

First QC Date

September 3, 2009

Last Update Submit

May 9, 2014

Conditions

Glaucoma

Keywords

24-hour IOP controlprimary open-angle glaucomabrimonidine/timololdorzolamide/timolol

Outcome Measures

Primary Outcomes (1)

  • To compare the quality of 24-hour IOP control after 2 months of chronic therapy with the Dorzolamide/Timolol fixed combination versus the Brimonidine/Timolol fixed combination in primary open-angle glaucoma.

    3 months

Secondary Outcomes (1)

  • Assess fluctuation of 24-hour pressure

    3 months

Study Arms (2)

Drug: Dorzolamide/Timolol

ACTIVE COMPARATOR
Drug: treatment with dorzolamide/timolol

Treatment with Brimonidine/Timolol

ACTIVE COMPARATOR
Drug: treatment with brimonidine/timolol

Interventions

treatment with dorzolamide/timololDRUG

24-hour IOP control with the two fixed combinations

Drug: Dorzolamide/Timolol
treatment with brimonidine/timololDRUG

24-hour pressure control with brimonidine/timolol

Treatment with Brimonidine/Timolol

Eligibility Criteria

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

You may qualify if:

  • Consecutive, newly diagnosed or previously untreated POAG patients
  • Patients with typical glaucomatous disc, or visual field damage
  • Patient must have IOP (at 10:00 ± 1 hour)greater than 25 mm Hg

You may not qualify if:

  • Uncontrolled glaucoma
  • Distance best corrected Snellen visual acuity worse than 1/10
  • Contraindications to brimonidine or dorzolamide and β-blockers
  • History of lack of response (\<10% morning IOP reduction) to any medication
  • Patient can not understand the instructions and adhere to medications
  • Patient is a female of childbearing potential or lactating mother
  • Prior surgery, past use of steroids (within 2 months)
  • Severe dry eyes and use of contact lenses
  • History of non-adherence
  • Patients with closed angles

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Glaucoma Unit, 1st University Dept of Ophthalmology

Thessaloniki, 546 36, Greece

Location

Related Publications (1)

  • Konstas AG, Quaranta L, Yan DB, Mikropoulos DG, Riva I, Gill NK, Barton K, Haidich AB. Twenty-four hour efficacy with the dorzolamide/timolol-fixed combination compared with the brimonidine/timolol-fixed combination in primary open-angle glaucoma. Eye (Lond). 2012 Jan;26(1):80-7. doi: 10.1038/eye.2011.239. Epub 2011 Sep 30.

    PMID: 21960068DERIVED

MeSH Terms

Conditions

GlaucomaGlaucoma, Open-Angle

Interventions

TherapeuticsdorzolamideTimololBrimonidine Tartrate

Condition Hierarchy (Ancestors)

Ocular HypertensionEye Diseases

Intervention Hierarchy (Ancestors)

PropanolaminesAmino AlcoholsAlcoholsOrganic ChemicalsPropanolsAminesThiadiazolesThiazolesSulfur CompoundsAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsMorpholinesOxazinesQuinoxalinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Officials

  • Anastasios Konstas, MD, phD

    Head of Glaucoma Unit

    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 3, 2009

First Posted

September 4, 2009

Study Start

January 1, 2009

Primary Completion

September 1, 2009

Study Completion

September 1, 2009

Last Updated

May 12, 2014

Record last verified: 2014-05

Locations

GR(1)