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Pharmacodynamics of Tafluprost 0.0015% Eye Drops: a Comparison Between the Preserved and Unpreserved Formulation

This study has been completed.
Sponsor:
Information provided by:
Santen Oy
ClinicalTrials.gov Identifier:
NCT00918346
First received: June 9, 2009
Last updated: December 10, 2010
Last verified: December 2010
History of Changes
  Purpose

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.


Condition Intervention Phase
Open-Angle Glaucoma
Ocular Hypertension
 Drug: Tafluprost 0.0015%
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Crossover Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
Official Title: Pharmacodynamics of Tafluprost 0.0015% Eye Drops: a Comparison Between the Preserved and Unpreserved Formulation in Patients With Open-angle Glaucoma or Ocular Hypertension

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Santen Oy:

Primary Outcome Measures:
  • Intraocular Pressures (IOPs) at Baseline [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    IOPs at baseline: mean IOP values at four timepoints (worse eye)

  • Intraocular Pressures (IOPs) at Week 1 [ Time Frame: Week 1 ] [ Designated as safety issue: No ]
    IOPs at week 1: mean IOP values at four timepoints (worse eye)

  • Intraocular Pressures (IOPs) at Week 4 [ Time Frame: Week 4 ] [ Designated as safety issue: No ]
    IOPs at week 4: mean IOP values at four timepoints (worse eye)

  • Primary Pharmacodynamic Variable Intention to Treat Efficacy Dataset: Change From Baseline in the Overall Diurnal Intraocular Pressure (IOP) at Week 4 (Worse Eye) [ Time Frame: Baseline - Week 4 ] [ Designated as safety issue: No ]
    Overall treatment difference at 4 weeks (unpreserved-preserved) evaluated using a repeated measurements analysis of covariance (RM ANCOVA) model.

  • Primary Pharmacodynamic Variable Per Protocol Efficacy Dataset: Change From Baseline in the Overall Diurnal Intraocular Pressure (IOP) at Week 4 (Worse Eye) [ Time Frame: Baseline - Week 4 ] [ Designated as safety issue: No ]
    Overall treatment difference at 4 weeks (unpreserved-preserved) evaluated using a repeated measurments analysis of covariance (RM ANCOVA) model.


Secondary Outcome Measures:
  • Overall and Time-wise Comparisons of IOP at Week 1 [ Time Frame: Baseline - Week 1 ] [ Designated as safety issue: No ]
    The overall and time-wise, i.e. at 8:00, 12:00, 16:00 and 20:00, comparisons of IOP at week 1 (diurnal IOP and IOP value at given timepoint at 1 week minus corresponding value at baseline: unpreserved-preserved) were done using the RM ANCOVA model.

  • Change From Baseline in Time-wise IOPs at Week 4 [ Time Frame: Baseline - Week 4 ] [ Designated as safety issue: No ]
    The time-wise, i.e. at 8:00, 12:00, 16:00 and 20:00, comparisons of IOP at week 4 (IOP value at given timepoint at 4 weeks minus corresponding value at baseline: unpreserved-preserved) were done using the RM ANCOVA model.


Enrollment: 43
Study Start Date: September 2005
Study Completion Date: April 2006
Primary Completion Date: March 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Tafluprost 0.0015% preserved formulation Drug: Tafluprost 0.0015%
Eye drops, 0.015 mg/ml, once daily to affected eye(s)
Experimental: Tafluprost 0.0015% unpreserved formulation Drug: Tafluprost 0.0015%
Eye drops, 0.015 mg/ml, once daily to affected eye(s)

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00918346

Locations
Finland
Oulu University Hospital
Oulu, Finland, 90029
Germany
Ulrich Richter's surgery
Regensburg, Germany, 93059
Praxis Dr. Hamacher
Starnberg, Germany, 82319
Sponsors and Collaborators
Santen Oy
Investigators
Principal Investigator: Juhani Airaksinen, Prof. University Hospital of Oulu
  More Information

No publications provided

Responsible Party: Auli Ropo, MD, PhD, Santen Oy
ClinicalTrials.gov Identifier: NCT00918346     History of Changes
Other Study ID Numbers: 77550
Study First Received: June 9, 2009
Results First Received: August 4, 2009
Last Updated: December 10, 2010
Health Authority: Finland: Finnish Medicines Agency
Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Santen Oy:
Ocular hypertension

Additional relevant MeSH terms:
Glaucoma
Glaucoma, Open-Angle
Hypertension
Ocular Hypertension
Eye Diseases
Vascular Diseases
Cardiovascular Diseases
Tetrahydrozoline
Nasal Decongestants
 Vasoconstrictor Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Respiratory System Agents
Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 16, 2013