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

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ClinicalTrials.gov Identifier: NCT00918346
Recruitment Status : Completed
First Posted : June 11, 2009
Results First Posted : September 15, 2009
Last Update Posted : December 28, 2010
Sponsor:
Information provided by:
Santen Oy

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.


Condition or disease Intervention/treatment Phase
Open-Angle Glaucoma Ocular Hypertension Drug: Tafluprost 0.0015% Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 43 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (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
Study Start Date : September 2005
Actual Primary Completion Date : March 2006
Actual Study Completion Date : April 2006


Arm Intervention/treatment
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)



Primary Outcome Measures :
  1. Intraocular Pressures (IOPs) at Baseline [ Time Frame: Baseline ]
    IOPs at baseline: mean IOP values at four timepoints (worse eye)

  2. Intraocular Pressures (IOPs) at Week 1 [ Time Frame: Week 1 ]
    IOPs at week 1: mean IOP values at four timepoints (worse eye)

  3. Intraocular Pressures (IOPs) at Week 4 [ Time Frame: Week 4 ]
    IOPs at week 4: mean IOP values at four timepoints (worse eye)

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

  5. 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 ]
    Overall treatment difference at 4 weeks (unpreserved-preserved) evaluated using a repeated measurments analysis of covariance (RM ANCOVA) model.


Secondary Outcome Measures :
  1. Overall and Time-wise Comparisons of IOP at Week 1 [ Time Frame: Baseline - Week 1 ]
    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.

  2. Change From Baseline in Time-wise IOPs at Week 4 [ Time Frame: Baseline - Week 4 ]
    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.



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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Auli Ropo, MD, PhD, Santen Oy
ClinicalTrials.gov Identifier: NCT00918346     History of Changes
Other Study ID Numbers: 77550
First Posted: June 11, 2009    Key Record Dates
Results First Posted: September 15, 2009
Last Update Posted: December 28, 2010
Last Verified: December 2010

Keywords provided by Santen Oy:
Ocular hypertension

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