Back to resultsPharmacodynamics of Tafluprost 0.0015% Eye Drops: a Comparison Between the Preserved and Unpreserved Formulation
Primary Purpose
Open-Angle Glaucoma, Ocular Hypertension
Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Tafluprost 0.0015%
Sponsored by
About this trial
This is an interventional treatment trial for Open-Angle Glaucoma focused on measuring Ocular hypertension
Eligibility Criteria
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
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
Sites / Locations
- Oulu University Hospital
- Ulrich Richter's surgery
- Praxis Dr. Hamacher
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Tafluprost 0.0015% preserved formulation
Tafluprost 0.0015% unpreserved formulation
Arm Description
Outcomes
Primary Outcome Measures
Intraocular Pressures (IOPs) at Baseline
IOPs at baseline: mean IOP values at four timepoints (worse eye)
Intraocular Pressures (IOPs) at Week 1
IOPs at week 1: mean IOP values at four timepoints (worse eye)
Intraocular Pressures (IOPs) at 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)
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)
Overall treatment difference at 4 weeks (unpreserved-preserved) evaluated using a repeated measurments analysis of covariance (RM ANCOVA) model.
Secondary Outcome Measures
Overall and Time-wise Comparisons of IOP at 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
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00918346
Brief Title
Pharmacodynamics of Tafluprost 0.0015% Eye Drops: a Comparison Between the Preserved and Unpreserved Formulation
Official Title
Pharmacodynamics of Tafluprost 0.0015% Eye Drops: a Comparison Between the Preserved and Unpreserved Formulation in Patients With Open-angle Glaucoma or Ocular Hypertension
Study Type
Interventional
2. Study Status
Record Verification Date
December 2010
Overall Recruitment Status
Completed
Study Start Date
September 2005 (undefined)
Primary Completion Date
March 2006 (Actual)
Study Completion Date
April 2006 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Santen Oy
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Open-Angle Glaucoma, Ocular Hypertension
Keywords
Ocular hypertension
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Crossover Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
43 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Tafluprost 0.0015% preserved formulation
Arm Type
Experimental
Arm Title
Tafluprost 0.0015% unpreserved formulation
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Tafluprost 0.0015%
Intervention Description
Eye drops, 0.015 mg/ml, once daily to affected eye(s)
Primary Outcome Measure Information:
Title
Intraocular Pressures (IOPs) at Baseline
Description
IOPs at baseline: mean IOP values at four timepoints (worse eye)
Time Frame
Baseline
Title
Intraocular Pressures (IOPs) at Week 1
Description
IOPs at week 1: mean IOP values at four timepoints (worse eye)
Time Frame
Week 1
Title
Intraocular Pressures (IOPs) at Week 4
Description
IOPs at week 4: mean IOP values at four timepoints (worse eye)
Time Frame
Week 4
Title
Primary Pharmacodynamic Variable Intention to Treat Efficacy Dataset: Change From Baseline in the Overall Diurnal Intraocular Pressure (IOP) at Week 4 (Worse Eye)
Description
Overall treatment difference at 4 weeks (unpreserved-preserved) evaluated using a repeated measurements analysis of covariance (RM ANCOVA) model.
Time Frame
Baseline - Week 4
Title
Primary Pharmacodynamic Variable Per Protocol Efficacy Dataset: Change From Baseline in the Overall Diurnal Intraocular Pressure (IOP) at Week 4 (Worse Eye)
Description
Overall treatment difference at 4 weeks (unpreserved-preserved) evaluated using a repeated measurments analysis of covariance (RM ANCOVA) model.
Time Frame
Baseline - Week 4
Secondary Outcome Measure Information:
Title
Overall and Time-wise Comparisons of IOP at Week 1
Description
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.
Time Frame
Baseline - Week 1
Title
Change From Baseline in Time-wise IOPs at Week 4
Description
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.
Time Frame
Baseline - Week 4
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Juhani Airaksinen, Prof.
Organizational Affiliation
University Hospital of Oulu
Official's Role
Principal Investigator
Facility Information:
Facility Name
Oulu University Hospital
City
Oulu
ZIP/Postal Code
90029
Country
Finland
Facility Name
Ulrich Richter's surgery
City
Regensburg
ZIP/Postal Code
93059
Country
Germany
Facility Name
Praxis Dr. Hamacher
City
Starnberg
ZIP/Postal Code
82319
Country
Germany
12. IPD Sharing Statement
Learn more about this trial
Pharmacodynamics of Tafluprost 0.0015% Eye Drops: a Comparison Between the Preserved and Unpreserved Formulation
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