Ocular Signs and Symptoms in Glaucoma Patients Switched From Latanoprost 0.005% to Preservative Free Tafluprost Eye Drops - Full Text View

Sponsored by:	Santen Oy
Information provided by:	Santen Oy
ClinicalTrials.gov Identifier:	NCT00596791

Purpose

The purpose of this study is to investigate if changes in ocular signs and symptoms occur in patients with ocular hypertension or glaucoma when they switch from latanoprost 0.005% (Xalatan) to preservative free Tafluprost eye drops.

Condition	Intervention	Phase
Ocular Hypertension Open-Angle Glaucoma	Drug: tafluprost	Phase III

Genetics Home Reference related topics: early-onset glaucoma

MedlinePlus related topics: Glaucoma High Blood Pressure

Drug Information available for: Latanoprost Tetrahydrozoline Tetrahydrozoline hydrochloride Tafluprost

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Open Label, Single Group Assignment
Official Title:	Ocular Signs and Symptoms in Glaucoma Patients Switched From Latanoprost 0.005% to Preservative Free Tafluprost Eye Drops

Further study details as provided by Santen Oy:

Primary Outcome Measures:

Change from screening in ocular symptoms and signs [ Time Frame: at week 6 and 12 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Safety and Quality of life parameters. [ Time Frame: From Screening (visit 1) to visits at week 2, 6 and 12. ] [ Designated as safety issue: No ]

Estimated Enrollment:	150
Study Start Date:	January 2008
Study Completion Date:	August 2008
Primary Completion Date:	July 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1 arm Open-lable study with one arm.	Drug: tafluprost prostaglandine analoque

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Patients with a diagnosis of ocular hypertension or open angle glaucoma for which the patient has been using latanoprost 0.005% as his/her prior medication. - Evaluable patients must have ocular surface related symptoms and/or signs with their prior medication.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00596791

Locations

Finland
Finn-Medi Research Oy
Tampere, Finland, 33520

Sponsors and Collaborators

Santen Oy

Investigators

Principal Investigator:

Hannu Uusitalo, Professor

Finn-Medi Research, Finland

More Information

Responsible Party:	Santen Oy ( Auli Ropo, Study Director )
Study ID Numbers:	Santen-77552, EudraCT number 2007-004872-37
Study First Received:	January 8, 2008
Last Updated:	January 9, 2009
ClinicalTrials.gov Identifier:	NCT00596791
Health Authority:	Finland: National Agency for Medicines

Study placed in the following topic categories:

Signs and Symptoms
Glaucoma
Eye Diseases
Glaucoma, Open-Angle
Vascular Diseases

Tetrahydrozoline
Latanoprost
Hypertension
Ocular Hypertension

Additional relevant MeSH terms:

Therapeutic Uses
Cardiovascular Diseases
Cardiovascular Agents
Antihypertensive Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009