NCT00596791

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Jan 2008

Shorter than P25 for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2008

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

January 8, 2008

Completed
9 days until next milestone

First Posted

Study publicly available on registry

January 17, 2008

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2008

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2008

Completed
Last Updated

January 12, 2009

Status Verified

January 1, 2009

Enrollment Period

6 months

First QC Date

January 8, 2008

Last Update Submit

January 9, 2009

Conditions

Ocular HypertensionOpen-Angle Glaucoma

Outcome Measures

Primary Outcomes (1)

  • Change from screening in ocular symptoms and signs

    at week 6 and 12

Secondary Outcomes (1)

  • Safety and Quality of life parameters.

    From Screening (visit 1) to visits at week 2, 6 and 12.

Study Arms (1)

1 arm

OTHER

Open-lable study with one arm.

Drug: tafluprost

Interventions

tafluprostDRUG

prostaglandine analoque

1 arm

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Finn-Medi Research Oy

Tampere, 33520, Finland

Location

MeSH Terms

Conditions

Ocular HypertensionGlaucoma, Open-Angle

Interventions

tafluprost

Condition Hierarchy (Ancestors)

Eye DiseasesGlaucoma

Study Officials

  • Hannu Uusitalo, Professor

    Finn-Medi Research, Finland

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

January 8, 2008

First Posted

January 17, 2008

Study Start

January 1, 2008

Primary Completion

July 1, 2008

Study Completion

August 1, 2008

Last Updated

January 12, 2009

Record last verified: 2009-01

Locations

FI(1)