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

Study Overview
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Brief Summary
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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.

Official Title
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Pharmacodynamics of Tafluprost 0.0015% Eye Drops: a Comparison Between the Preserved and Unpreserved Formulation in Patients With Open-angle Glaucoma or Ocular Hypertension

Conditions
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Open-Angle Glaucoma, Ocular Hypertension

Intervention / Treatment
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* Drug: Tafluprost 0.0015%


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Tafluprost 0.0015% preserved formulation<br> | Drug: Tafluprost 0.0015%<br>* Eye drops, 0.015 mg/ml, once daily to affected eye(s)<br>|
| Experimental: Tafluprost 0.0015% unpreserved formulation<br> | Drug: Tafluprost 0.0015%<br>* Eye drops, 0.015 mg/ml, once daily to affected eye(s)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall and Time-wise Comparisons of IOP at 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. | Baseline - Week 1 | 
| Change From Baseline in Time-wise IOPs at 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. | Baseline - Week 4 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Ocular hypertension