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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00596791
Other study ID # Santen-77552
Secondary ID EudraCT number 2
Status Completed
Phase Phase 3
First received January 8, 2008
Last updated January 9, 2009
Start date January 2008
Est. completion date August 2008

Study information

Verified date January 2009
Source Santen Oy
Contact n/a
Is FDA regulated No
Health authority Finland: Finnish Medicines Agency
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 150
Est. completion date August 2008
Est. primary completion date July 2008
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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.

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Intervention

Drug:
tafluprost
prostaglandine analoque

Locations

Country Name City State
Finland Finn-Medi Research Oy Tampere

Sponsors (1)

Lead Sponsor Collaborator
Santen Oy

Country where clinical trial is conducted

Finland, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change from screening in ocular symptoms and signs at week 6 and 12 No
Secondary Safety and Quality of life parameters. From Screening (visit 1) to visits at week 2, 6 and 12. No
See also
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