Pharmacodynamics of Tafluprost 0.0015% Eye Drops: a Comparison Between the Preserved and Unpreserved Formulation

Phase 3

Completed

• Conditions: Open-Angle Glaucoma; Ocular Hypertension
• Interventions: Drug: Tafluprost 0.0015%

• Registration Number: NCT00918346
• Lead Sponsor: Santen Oy

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2005-09
• Primary Completion: 2006-03
• Study Completion: 2006-04
• Study First Submitted: 2009-06-09
• Study First Submitted QC: 2009-06-10
• Study First Posted: 2009-06-11
• Results First Submitted: 2009-08-04
• Results First Submitted QC: 2009-08-04
• Results First Posted: 2009-09-15
• Status Verified: 2010-12
• Last Update Submitted: 2010-12-10
• Last Update Posted: 2010-12-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 43

Inclusion Criteria

• Age 18 years or more
• A diagnosis of open angle glaucoma or ocular hypertension
• Prior use of prostaglandin(s)
• Intra ocular pressure of 22-34 mmHg in at least one eye

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Exclusion Criteria

• Females who are pregnant, nursing or planning a pregnancy, or females of childbearing potential who are not using a reliable method of contraception
• Previous participation in any clinical trial in which tafluprost was an investigational drug or use of contact lenses at screening or during the study
• Presence of any abnormality or significant illness that could be expected to interfere with the study

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Tafluprost 0.0015% preserved formulation	Tafluprost 0.0015%	-
Tafluprost 0.0015% unpreserved formulation	Tafluprost 0.0015%	-

Primary Outcome Measures

Name	Time	Method
Intraocular Pressures (IOPs) at Baseline	Baseline	IOPs at baseline: mean IOP values at four timepoints (worse eye)
Intraocular Pressures (IOPs) at Week 1	Week 1	IOPs at week 1: mean IOP values at four timepoints (worse eye)
Intraocular Pressures (IOPs) at Week 4	Week 4	IOPs at week 4: mean IOP values at four timepoints (worse eye)
Primary Pharmacodynamic Variable Intention to Treat Efficacy Dataset: Change From Baseline in the Overall Diurnal Intraocular Pressure (IOP) at Week 4 (Worse Eye)	Baseline - Week 4	Overall treatment difference at 4 weeks (unpreserved-preserved) evaluated using a repeated measurements analysis of covariance (RM ANCOVA) model.
Primary Pharmacodynamic Variable Per Protocol Efficacy Dataset: Change From Baseline in the Overall Diurnal Intraocular Pressure (IOP) at Week 4 (Worse Eye)	Baseline - Week 4	Overall treatment difference at 4 weeks (unpreserved-preserved) evaluated using a repeated measurments analysis of covariance (RM ANCOVA) model.

Secondary Outcome Measures

Name	Time	Method
Overall and Time-wise Comparisons of IOP at Week 1	Baseline - Week 1	The overall and time-wise, i.e. at 8:00, 12:00, 16:00 and 20:00, comparisons of IOP at week 1 (diurnal IOP and IOP value at given timepoint at 1 week minus corresponding value at baseline: unpreserved-preserved) were done using the RM ANCOVA model.
Change From Baseline in Time-wise IOPs at Week 4	Baseline - Week 4	The time-wise, i.e. at 8:00, 12:00, 16:00 and 20:00, comparisons of IOP at week 4 (IOP value at given timepoint at 4 weeks minus corresponding value at baseline: unpreserved-preserved) were done using the RM ANCOVA model.

Trial Locations

Locations (3)

Ulrich Richter's surgery; 🇩🇪 Regensburg, Germany

Oulu University Hospital; 🇫🇮 Oulu, Finland

Praxis Dr. Hamacher; 🇩🇪 Starnberg, Germany