Ocular Signs and Symptoms in Glaucoma Patients Switched F... | NCT00596791

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

NCT00596791

Sponsor

Santen Oy

Status

Completed

Last Update Posted

Jan 12, 2009Estimated

Enrollment

150Estimated

Phase

Phase 3

Conditions

Ocular Hypertension
Open-Angle Glaucoma

Interventions

tafluprost

Countries

Finland

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
EudraCT number 2007-004872-37

Status Module

Record Verification Date

Jan 2009

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2008

Primary Completion Date

Jul 2008Actual

Completion Date

Aug 2008Actual

First Submitted Date

Jan 8, 2008

First Submission Date that Met QC Criteria

Jan 16, 2008

First Posted Date

Jan 17, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 9, 2009

Last Update Posted Date

Jan 12, 2009Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

150Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1 arm	Other	Open-lable study with one arm.	Drug: tafluprost

Interventions

Name	Type	Description	Arm Group Labels	Other Names
tafluprost	Drug	prostaglandine analoque	1 arm

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change from screening in ocular symptoms and signs		at week 6 and 12

Secondary Outcomes

Measure	Description	Time Frame
Safety and Quality of life parameters.		From Screening (visit 1) to visits at week 2, 6 and 12.

Other Outcomes

Not provided

Eligibility Module

Eligibility 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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Hannu Uusitalo, Professor	Finn-Medi Research, Finland	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Finn-Medi Research Oy		Tampere		33520	Finland

Condition Browse Module

MeSH Terms

ID	Term
D009798	Ocular Hypertension
D005902	Glaucoma, Open-Angle

Ancestor Terms

ID	Term
D005128	Eye Diseases
D005901	Glaucoma

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C485333	tafluprost

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided