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

Ocular Hypertension Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00918346
• Other study ID #: 77550
• Status: Completed
• Phase: Phase 3
• First received: June 9, 2009
• Last updated: December 10, 2010
• Start date: September 2005
• Est. completion date: April 2006

Study information

• Verified date: December 2010
• Source: Santen Oy
• Contact: n/a
• Is FDA regulated: No
• Health authority: Finland: Finnish Medicines AgencyGermany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 43
• Est. completion date: April 2006
• Est. primary completion date: March 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Glaucoma
• Glaucoma, Open-Angle
• Hypertension
• Ocular Hypertension
• Open-Angle Glaucoma

Intervention

Drug:
• Tafluprost 0.0015%
Eye drops, 0.015 mg/ml, once daily to affected eye(s)

Locations

Country	Name	City	State
Finland	Oulu University Hospital	Oulu
Germany	Ulrich Richter's surgery	Regensburg
Germany	Praxis Dr. Hamacher	Starnberg

Sponsors (1)

Lead Sponsor	Collaborator
Santen Oy

Countries where clinical trial is conducted

Finland,  Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Intraocular Pressures (IOPs) at Baseline	IOPs at baseline: mean IOP values at four timepoints (worse eye)	Baseline	No
Primary	Intraocular Pressures (IOPs) at Week 1	IOPs at week 1: mean IOP values at four timepoints (worse eye)	Week 1	No
Primary	Intraocular Pressures (IOPs) at Week 4	IOPs at week 4: mean IOP values at four timepoints (worse eye)	Week 4	No
Primary	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	No
Primary	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.	Baseline - Week 4	No
Secondary	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.	Baseline - Week 1	No
Secondary	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.	Baseline - Week 4	No