NCT00918346|CompletedPhase 3Results
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Sponsor study identifier
interventional
43
2 countries
3
Study Start
September 2005
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
March 2006
Actual (reported)Study Completion
April 2006
Actual (reported)The objective of this study is to investigate the pharmacodynamics (as expressed in intraocular pressure \[IOP\]) of two formulations of tafluprost 0.0015% eyedrops (preserved and unpreserved) in patients with open-angle glaucoma or ocular hypertension. The primary aim of this study is to show that IOP reduction between the two formulations is equivalent at the end of the 4 week treatment period.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
April 2006
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
September 2005
Date type not reportedThis date has not been verified as actual or estimated.
March 2006
Actual (reported)April 2006
Actual (reported)June 9, 2009
Actual (reported)June 11, 2009
Actual (reported)September 15, 2009
Actual (reported)Intraocular Pressures (IOPs) at Baseline
IOPs at baseline: mean IOP values at four timepoints (worse eye)
Baseline
Intraocular Pressures (IOPs) at Week 1
IOPs at week 1: mean IOP values at four timepoints (worse eye)
Week 1
Intraocular Pressures (IOPs) at Week 4
IOPs at week 4: mean IOP values at four timepoints (worse eye)
Week 4
Primary Pharmacodynamic Variable Intention to Treat Efficacy Dataset: Change From Baseline in the Overall Diurnal Intraocular Pressure (IOP) at Week 4 (Worse Eye)
Overall treatment difference at 4 weeks (unpreserved-preserved) evaluated using a repeated measurements analysis of covariance (RM ANCOVA) model.
Baseline - Week 4
Primary Pharmacodynamic Variable Per Protocol Efficacy Dataset: Change From Baseline in the Overall Diurnal Intraocular Pressure (IOP) at Week 4 (Worse Eye)
Overall treatment difference at 4 weeks (unpreserved-preserved) evaluated using a repeated measurments analysis of covariance (RM ANCOVA) model.
Overall and Time-wise Comparisons of IOP at Week 1
Baseline - Week 1
Change From Baseline in Time-wise IOPs at Week 4
Baseline - Week 4
Eye drops, 0.015 mg/ml, once daily to affected eye(s)
Oulu University Hospital
Oulu, 90029, Finland
Ulrich Richter's surgery
Regensburg, 93059, Germany
Praxis Dr. Hamacher
Starnberg, 82319, Germany
Juhani Airaksinen, Prof.
University Hospital of Oulu
43 participants (actual enrollment reported by the registry).
First Submitted
June 9, 2009
First Posted
June 11, 2009
Study Start
September 2005
Date type not reportedThis date has not been verified as actual or estimated.
Baseline - Week 4
Contact the study team to confirm eligibility.
Primary Completion
March 2006
Actual (reported)Study Completion
April 2006
Actual (reported)Last Updated
December 28, 2010
Results First Posted
September 15, 2009
Record last verified: 2010-12
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Source: ClinicalTrials.gov.
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