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

NCT ID: NCT00918346

Last Updated: 2010-12-28

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

43 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-09-30

Study Completion Date

2006-04-30

Brief Summary

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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

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Conditions

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Open-Angle Glaucoma Ocular Hypertension

Keywords

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Ocular hypertension

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

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Tafluprost 0.0015% preserved formulation

Group Type EXPERIMENTAL

Tafluprost 0.0015%

Intervention Type DRUG

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

Tafluprost 0.0015% unpreserved formulation

Group Type EXPERIMENTAL

Tafluprost 0.0015%

Intervention Type DRUG

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

Interventions

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Tafluprost 0.0015%

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

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Santen Oy

INDUSTRY

Sponsor Role lead

Responsible Party

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Santen Oy

Principal Investigators

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Juhani Airaksinen, Prof.

Role: PRINCIPAL_INVESTIGATOR

University Hospital of Oulu

Locations

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Oulu University Hospital

Oulu, , Finland

Site Status

Ulrich Richter's surgery

Regensburg, , Germany

Site Status

Praxis Dr. Hamacher

Starnberg, , Germany

Site Status

Countries

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Finland Germany

Other Identifiers

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77550

Identifier Type: -

Identifier Source: org_study_id