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NCT Number: NCT00918346

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

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.

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Key information

Conditions

Open-angle Glaucoma Eye Diseases Glaucoma Glaucoma, Open-Angle Ocular Hypertension

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Oulu University Hospital, Oulu, Finland

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Tafluprost 0.0015%

Drug

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

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Santen Oy

Industry

Registry information

Official study 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

Important dates

Study start
2005
Primary completion
2006
Study completion
2006
First posted
Jun 11, 2009
Registry last updated
Dec 28, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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