E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Open angle glaucoma or ocular hypertension |
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MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
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.
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).
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E.2.2 | Secondary objectives of the trial |
Analysis of safety variables (adverse events, visual acuity, ophthalmoscopy, biomicroscopy and visual field tests) 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. |
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E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal inclusion criteria |
- 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
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E.4 | Principal 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 - 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
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E.5 End points |
E.5.1 | Primary end point(s) |
Primary Variable of pharmacodynamics : Change from baseline in the overall diurnal IOP at 4 weeks
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | No |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | Yes |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | Information not present in EudraCT |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | Yes |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | Yes |
E.8.1.7 | Other | Yes |
E.8.1.7.1 | Other trial design description |
Investigator masked (single blind) |
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E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | Information not present in EudraCT |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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Post study visit, study schedule in the protocol |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 0 |
E.8.9.1 | In the Member State concerned months | 7 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 0 |
E.8.9.2 | In all countries concerned by the trial months | 7 |