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

Santen Oy43 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Open-Angle Glaucoma Ocular Hypertension

Interventions

Tafluprost 0.0015%DRUG

Eye drops, 0.015 mg/ml, once daily to affected eye(s)

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (3)

Oulu University Hospital

Oulu, Finland

Ulrich Richter's surgery

Regensburg, Germany

Praxis Dr. Hamacher

Starnberg, Germany

Outcomes

Primary Outcomes

Intraocular Pressures (IOPs) at Baseline

IOPs at baseline: mean IOP values at four timepoints (worse eye)

Time frame: Baseline

Intraocular Pressures (IOPs) at Week 1

IOPs at week 1: mean IOP values at four timepoints (worse eye)

Time frame: Week 1

Intraocular Pressures (IOPs) at Week 4

IOPs at week 4: mean IOP values at four timepoints (worse eye)

Time frame: 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.

Time frame: 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.

Time frame: Baseline - Week 4

Secondary Outcomes

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.

Time frame: Baseline - Week 1

Change From Baseline in Time-wise IOPs at Week 4

Data from ClinicalTrials.gov

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