NCT00918346

Brief Summary

The objective of this study is to investigate the pharmacodynamics (as expressed in intraocular pressure \[IOP\]) of two formulations of tafluprost 0.0015% eyedrops (preserved and unpreserved) in patients with open-angle glaucoma or ocular hypertension. The primary aim of this study is to show that IOP reduction between the two formulations is equivalent at the end of the 4 week treatment period.

Trial Health

90
On Track

Trial Health Score

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

Enrollment
43

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Sep 2005

Shorter than P25 for phase_3

Geographic Reach
2 countries

3 active sites

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

September 1, 2005

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2006

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2006

Completed
3.2 years until next milestone

First Submitted

Initial submission to the registry

June 9, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 11, 2009

Completed
3 months until next milestone

Results Posted

Study results publicly available

September 15, 2009

Completed
Last Updated

December 28, 2010

Status Verified

December 1, 2010

Enrollment Period

6 months

First QC Date

June 9, 2009

Results QC Date

August 4, 2009

Last Update Submit

December 10, 2010

Conditions

Open-Angle GlaucomaOcular Hypertension

Keywords

Ocular hypertension

Outcome Measures

Primary Outcomes (5)

  • Intraocular Pressures (IOPs) at Baseline

    IOPs at baseline: mean IOP values at four timepoints (worse eye)

    Baseline

  • Intraocular Pressures (IOPs) at Week 1

    IOPs at week 1: mean IOP values at four timepoints (worse eye)

    Week 1

  • Intraocular Pressures (IOPs) at Week 4

    IOPs at week 4: mean IOP values at four timepoints (worse eye)

    Week 4

  • Primary Pharmacodynamic Variable Intention to Treat Efficacy Dataset: Change From Baseline in the Overall Diurnal Intraocular Pressure (IOP) at Week 4 (Worse Eye)

    Overall treatment difference at 4 weeks (unpreserved-preserved) evaluated using a repeated measurements analysis of covariance (RM ANCOVA) model.

    Baseline - Week 4

  • Primary Pharmacodynamic Variable Per Protocol Efficacy Dataset: Change From Baseline in the Overall Diurnal Intraocular Pressure (IOP) at Week 4 (Worse Eye)

    Overall treatment difference at 4 weeks (unpreserved-preserved) evaluated using a repeated measurments analysis of covariance (RM ANCOVA) model.

    Baseline - Week 4

Secondary Outcomes (2)

  • Overall and Time-wise Comparisons of IOP at Week 1

    Baseline - Week 1

  • Change From Baseline in Time-wise IOPs at Week 4

    Baseline - Week 4

Study Arms (2)

Tafluprost 0.0015% preserved formulation

EXPERIMENTAL
Drug: Tafluprost 0.0015%

Tafluprost 0.0015% unpreserved formulation

EXPERIMENTAL
Drug: Tafluprost 0.0015%

Interventions

Tafluprost 0.0015%DRUG

Eye drops, 0.015 mg/ml, once daily to affected eye(s)

Tafluprost 0.0015% preserved formulationTafluprost 0.0015% unpreserved formulation

Eligibility Criteria

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

You may qualify if:

  • Age 18 years or more
  • A diagnosis of open angle glaucoma or ocular hypertension
  • Prior use of prostaglandin(s)
  • Intra ocular pressure of 22-34 mmHg in at least one eye

You may not qualify if:

  • Females who are pregnant, nursing or planning a pregnancy, or females of childbearing potential who are not using a reliable method of contraception
  • Previous participation in any clinical trial in which tafluprost was an investigational drug or use of contact lenses at screening or during the study
  • Presence of any abnormality or significant illness that could be expected to interfere with the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Oulu University Hospital

Oulu, 90029, Finland

Location

Ulrich Richter's surgery

Regensburg, 93059, Germany

Location

Praxis Dr. Hamacher

Starnberg, 82319, Germany

Location

MeSH Terms

Conditions

Glaucoma, Open-AngleOcular Hypertension

Condition Hierarchy (Ancestors)

GlaucomaEye Diseases

Results Point of Contact

Title
Auli Ropo
Organization
Santen Oy
auli.ropo@santen.fi
+358405012416

Study Officials

  • Juhani Airaksinen, Prof.

    University Hospital of Oulu

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

June 9, 2009

First Posted

June 11, 2009

Study Start

September 1, 2005

Primary Completion

March 1, 2006

Study Completion

April 1, 2006

Last Updated

December 28, 2010

Results First Posted

September 15, 2009

Record last verified: 2010-12

Locations

DE(2)FI(1)