NCT00273481

Brief Summary

To compare the intraocular pressure efficacy and safety of the DTFC given twice daily versus the LTFC given once every morning following a run-in period with timolol maleate given twice daily.

Trial Health

90
On Track

Trial Health Score

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

Enrollment
33

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Sep 2005

Geographic Reach
2 countries

2 active sites

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

September 1, 2005

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

January 6, 2006

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 9, 2006

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2007

Completed
Last Updated

November 19, 2008

Status Verified

November 1, 2008

First QC Date

January 6, 2006

Last Update Submit

November 18, 2008

Conditions

Open-Angle GlaucomaOcular Hypertension

Interventions

dorzolamide 2%/timolol maleate 0.5% fixed combinationDRUG
latanoprost 0.005%/timolol maleate 0.5% fixed combinationDRUG
timolol maleate 0.5%DRUG
placeboDRUG

Eligibility Criteria

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

You may qualify if:

  • adults with primary open-angle or pigment-dispersion glaucoma, or ocular hypertension
  • at baseline the intraocular pressure should be 20 to 32 mm Hg inclusive at 08:00 measurement (Visit 2) after dosing with timolol the evening before
  • the intraocular pressure should be 32 mm Hg or less at all the time points in both eyes at Visit 2
  • visual acuity should be 6/60 or better in the study eye(s)

You may not qualify if:

  • any anticipated change in systemic hypotensive therapy during the trial
  • use of any corticosteroids by any route for more than two weeks during the study
  • contraindications to study medicines

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Lawson Health Research Insitute

London, Ontario, N6A 4G5, Canada

Location

University Eye Clinic

Ljubljana, A525, Slovenia

Location

MeSH Terms

Conditions

Glaucoma, Open-AngleOcular Hypertension

Interventions

dorzolamideTimololLatanoprost

Condition Hierarchy (Ancestors)

GlaucomaEye Diseases

Intervention Hierarchy (Ancestors)

PropanolaminesAmino AlcoholsAlcoholsOrganic ChemicalsPropanolsAminesThiadiazolesThiazolesSulfur CompoundsAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsMorpholinesOxazinesProstaglandins F, SyntheticProstaglandins, SyntheticProstaglandinsEicosanoidsFatty Acids, UnsaturatedFatty AcidsLipidsAutacoidsInflammation MediatorsBiological Factors

Study Officials

  • William C. Stewart, MD

    Pharmaceutical Research Network, LLC

    STUDY DIRECTOR

  • Cindy M. Hutnik, BSc, PhD, MD

    London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

    PRINCIPAL INVESTIGATOR

  • Barbara Cvenkel, MD

    University Eye Clinic Ljubljana

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 6, 2006

First Posted

January 9, 2006

Study Start

September 1, 2005

Study Completion

April 1, 2007

Last Updated

November 19, 2008

Record last verified: 2008-11

Locations

CA(1)SL(1)