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

This study has been completed.

Sponsor:

Information provided by:

Santen Oy

ClinicalTrials.gov Identifier:

NCT00596791

First received: January 8, 2008

Last updated: January 9, 2009

Last verified: January 2009

History of Changes

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 3


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

Resource links provided by NLM:

Genetics Home Reference related topics: early-onset glaucoma

MedlinePlus related topics: Glaucoma

Drug Information available for: Latanoprost Tafluprost

Genetic and Rare Diseases Information Center resources: Pigment-dispersion Syndrome

U.S. FDA Resources

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 (Adult, Senior)
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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:	Auli Ropo, Study Director, Santen Oy
ClinicalTrials.gov Identifier:	NCT00596791 History of Changes
Other Study ID Numbers:	Santen-77552 EudraCT number 2007-004872-37
Study First Received:	January 8, 2008
Last Updated:	January 9, 2009
Health Authority:	Finland: Finnish Medicines Agency

Additional relevant MeSH terms:


Glaucoma Glaucoma, Open-Angle Ocular Hypertension Signs and Symptoms Eye Diseases	Ophthalmic Solutions Latanoprost Pharmaceutical Solutions Antihypertensive Agents

ClinicalTrials.gov processed this record on September 27, 2016

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