Phase 3
Completed N=43
Pharmacodynamics of Tafluprost 0.0015% Eye Drops: a Comparison Between the Preserved and Unpreserved Formulation
Source: ClinicalTrials.gov NCT00918346 ↗Enrolled (actual)
43
Serious AEs
0.0%
Results posted
Sep 2009
Primary outcomePrimary: Intraocular Pressures (IOPs) at Baseline — 22.57; 22.98; 20.86; 21.78 mmHg
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Intraocular Pressures (IOPs) at Baseline |
22.57; 22.98; 20.86; 21.78; 21.73; 21.51 | — |
| PRIMARY Intraocular Pressures (IOPs) at Week 1 |
16.43; 16.21; 15.77; 15.72; 16.23; 15.83 | — |
| PRIMARY Intraocular Pressures (IOPs) at Week 4 |
16.39; 16.80; 16.30; 16.67; 16.64; 16.71 | — |
| PRIMARY Primary Pharmacodynamic Variable Intention to Treat Efficacy Dataset: Change From Baseline in the Overall Diurnal Intraocular Pressure (IOP) at Week 4 (Worse Eye) |
0.01 | 0.96 |
| PRIMARY Primary Pharmacodynamic Variable Per Protocol Efficacy Dataset: Change From Baseline in the Overall Diurnal Intraocular Pressure (IOP) at Week 4 (Worse Eye) |
-0.05 | 0.83 |
| SECONDARY Overall and Time-wise Comparisons of IOP at Week 1 |
-0.27; -0.32; -0.25; -0.39; -0.13 | — |
| SECONDARY Change From Baseline in Time-wise IOPs at Week 4 |
0.24; 0.11; 0.00; -0.30 | — |
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT00918346). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.