E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Open Angle Glaucoma or Ocular Hypertension |
|
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 13.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10030348 |
E.1.2 | Term | Open angle glaucoma |
E.1.2 | System Organ Class | 10015919 - Eye disorders |
|
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 |
To assess the equivalence of the topically administered Travoprost 0.004 % eye drops, solution (test formulation) compared to Travatan® 40 µg/ml Augentropfen (reference formulation) in lowering intraocular pressure (IOP) in patients with open angle glaucoma or ocular hypertension. |
|
E.2.2 | Secondary objectives of the trial |
To assess the safety and tolerability of repeated topical administration of Travoprost 0.004 % eye drops, solution in subjects with open angle glaucoma or ocular hypertension. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Main inclusion criteria: - Informed consent signed by the subject - Male and female patients, aged 18 years or older - A clinical diagnosis of open angle glaucoma, pseudoexfoliation or pigment dispersion glaucoma, or ocular hypertension in one or both eyes - IOP controllable on one drug treatment in the study eye in a way that assures clinical stability of vision and the optic nerve throughout the study - Baseline IOP > 20 mmHg in the untreated study eye (in eyes not included in the study IOP must be controlled by either no pharmacological treatment, or by the study medicine or by initial therapy) at visit 2 - Best corrected visual acuity of 20/200 or better in the study eye |
|
E.4 | Principal exclusion criteria |
Main exclusion criteria: - Evidence in the subject's medical history or in the medical examination of any clinically significant hepatic, renal, gastrointestinal, cardiovascular, pulmonary, haematological or other significant acute or chronic abnormalities which might influence either the safety of the subject or the absorption, distribution, metabolism or excretion of the active agent under investigation - History of hypersensitivity to the investigational medicinal product or to any drug with similar chemical structure or to any excipients present in the pharmaceutical form of the investigational medicinal product - Acute infection or current ocular infection, i.e. conjunctivitis or keratitis - Chronic or recurrent inflammatory eye disease - Relevant ocular trauma within the past six months - Any abnormality preventing reliable applanation tonometry - Intraocular surgery or laser treatment within the past three months - Inability to discontinue contact lens wear during the study - Use of any systemic medication that would affect IOP with less than a 1-month stable dosing regimen before the screening visit as stated by the subject at screening |
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E.5 End points |
E.5.1 | Primary end point(s) |
The primary efficacy parameter will be the difference in IOP of the study eye from visit 1 (baseline) to day 42 ± 5 in each period: δIOP =IOP baseline – IOP travoprost |
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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 | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | Yes |
E.6.8 | Bioequivalence | Yes |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
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 | No |
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 |
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E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Yes |
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.8.4.1 | Number of sites anticipated in Member State concerned | 4 |
E.8.5 | The trial involves multiple Member States | No |
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 | No |
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
|
end of study at Visit 4 (an optional safety follow-up visit is planned at Visit 5) |
|
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 | 10 |
E.8.9.1 | In the Member State concerned days | 0 |
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 | 0 |
E.8.9.2 | In all countries concerned by the trial days | 0 |