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

Pharmacodynamics of Tafluprost 0.0015% Eye Drops: a Comparison Between the Preserved and Unpreserved Formulation in Patients With Open-angle Glaucoma or Ocular Hypertension

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.

Study Overview

• Status: Completed
• Conditions: Ocular Hypertension; Open-Angle Glaucoma
• Intervention / Treatment: Drug: Tafluprost 0.0015%

• Study Type: Interventional
• Enrollment (Actual): 43
• Phase: Phase 3

Contacts and Locations

Study Locations

• Finland
  • Oulu, Finland, 90029
    • Oulu University Hospital
• Germany
  • Regensburg, Germany, 93059
    • Ulrich Richter's surgery
  • Starnberg, Germany, 82319
    • Praxis Dr. Hamacher

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Tafluprost 0.0015% preserved formulation	Drug: Tafluprost 0.0015%; Eye drops, 0.015 mg/ml, once daily to affected eye(s)
Experimental: Tafluprost 0.0015% unpreserved formulation	Drug: Tafluprost 0.0015%; Eye drops, 0.015 mg/ml, once daily to affected eye(s)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Baseline - Week 4

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: Santen Oy
• Investigators: Principal Investigator: Juhani Airaksinen, Prof., University Hospital of Oulu

Study record dates

Study Major Dates

• Study Start: September 1, 2005
• Primary Completion (Actual): March 1, 2006
• Study Completion (Actual): April 1, 2006

Study Registration Dates

• First Submitted: June 9, 2009
• First Submitted That Met QC Criteria: June 10, 2009
• First Posted (Estimate): June 11, 2009

Study Record Updates

• Last Update Posted (Estimate): December 28, 2010
• Last Update Submitted That Met QC Criteria: December 10, 2010
• Last Verified: December 1, 2010

More Information

Terms related to this study

• Keywords: Ocular hypertension
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Eye Diseases; Glaucoma; Glaucoma, Open-Angle; Ocular Hypertension; Hypertension
• Other Study ID Numbers: 77550