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
- Open angle glaucoma or ocular hypertension
- Registration Number
- EUCTR2005-002574-29-DE
- Lead Sponsor
- Santen Oy
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 40
- Aged 18 years or more
- A diagnosis of open-angle glaucoma (primary open-angle glaucoma, capsular glaucoma or pigmentary glaucoma) or ocular hypertension
- Prior use of prostaglandin(s) and a known positive treatment response to PGs (a 15% reduction in IOP confirmed in anamnesis)
- An untreated (after washout) IOP of 22-34 mmHg in at least one eye at the 8:00 measurement at baseline (Visit 2)
- A best corrected ETDRS visual acuity score of +0.6 logMAR or better in each eye
- Willing to follow instructions and a written informed consent
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
- 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
- Any uncontrolled systemic disease (e.g., hypertension, diabetes)
- Filtration surgery or any other ocular (including ocular laser procedures) surgery within 6 months prior to Visit 1 (screening) in either eye
- Change of an existing chronic therapy that could substantially effect the IOP or the study outcomes within 30 days prior to Visit 1 (screening), or anticipated change in such therapy during the study
- IOP greater than 34 mmHg at any time point in any eye at Visit 2 (baseline)
- Known allergy or hypersensitivity to the study medications or their components, including benzalkonium chloride (BAK)
- Use of contact lenses at Visit 1 (screening) or during the study
- Any active external ocular disease, inflammation, or infection of the eye and/or eyelids within 3 months from the Screening visit
- Any ocular, systemic or psychiatric disease/condition that in the opinion of the investigator may put the patient at a significant risk or may confound the study results or may interefere significantly with the patient’s participation in the study
- Any corneal abnormality or other condition preventing reliable applanation tonometry
- Anterior chamber angle less than grade 2 according to Schaffer classification as measured by gonioscopy
- Advanced visual field defect or a visual field defect that is anticipated to progress during the study period
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: The objective of this study is to investigate the pharmacodynamics (as expressed in IOP) of two formulations of tafluprost 0.0015% eyedrops (multidose = preserved and single dose = unpreserved) in patients with open-angle glaucoma or ocular hypertension. <br><br>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 (change from baseline in the overall diurnal IOP at 4 weeks). <br> <br>;Secondary Objective: Analysis of safety variables (adverse events, visual acuity, ophthalmoscopy, biomicroscopy and visual field tests)<br>Secondary pharmacodynamic variables: change from baseline in time-wise IOPs (8:00, 12:00, 16:00 and 20:00) at 4 weeks and change from baseline in the overall diurnal IOPs and timewise IOPs (8:00, 12:00, 16:00 and 20:00) at 1 week.;Primary end point(s): Primary Variable of pharmacodynamics :Change from baseline in the overall diurnal IOP at 4 weeks<br>
- Secondary Outcome Measures
Name Time Method