E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Open-angle glaucoma and ocular hypertension |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 6.1 |
E.1.2 | Level | HLGT |
E.1.2 | Classification code | 10018307 |
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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 primary objective of this study is to compare the IOP-lowering efficacy and safety of dosing of Travoprost 0.004 /Timolol 0.5 Ophthalmic Solution once-daily morning dosing vs. Dorzolamide 2 /Timolol 0.5 Ophthalmic Solution, dosed twice-daily, in patients with open-angle glaucoma or ocular hypertension. |
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E.2.2 | Secondary objectives of the trial |
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E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal inclusion criteria |
Male or female patients 18 years of age or older diagnosed with open-angle glaucoma or ocular hypertension who are currently on one or more IOP-lowering medications and, in the opinion of the investigator, would benefit from one of the combination therapies. Patients must meet the following IOP entry criteria in at least one treated eye 1 For the qualifying treated eye s , the mean IOP must be greater or equal to 24 mmHG at 9 AM and 21 mmHG at 4 PM on the Eligibility Visits 1 and 2, 2 The mean IOP in either eye must not be greater than 36 mmHg at any time point, 3 The same eye s must qualify at both time points at the Eligibility Visits 1 and 2. Patients must be able to discontinue use of all IOP-lowering medication s for a minimum period of 5 days 1 day, to 28 days 1 day prior to the Eligibility Visit 1. Only patients who satisfy all informed consent requirements may be included in the study. |
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E.4 | Principal exclusion criteria |
Females of childbearing potential those who are not surgically sterilized at least 3 months prior to study start or who are at least two years post-menopausal if they are pregnant or breast-feeding or not using highly effective birth control measures. Patients with any form of glaucoma other than open-angle glaucoma or ocular hypertension. Patients who are currently on therapy or were on therapy with another investigational agent within 30 days prior to the Eligibility 1 Visit. History of chronic recurrent, or current severe inflammatory eye disease i.e., scleritis, uveitis, herpes keratitis in either eye. History of, or current other severe ocular pathology including severe dry eye in either eye or serious hypersensitivity to prostaglandin drugs or their analoques, that would preclude the administration of a topical prostaglandin analogue, carbonic anhydrase inhibitor, or beta-blocker. Patients who cannot safely discontinue their glucocorticoid medications administered by any route. History of spontaneous or current hypoglycaemia or uncontrolled diabetes. Any abnormality preventing reliable applanation tonometry of either eye. History of, or current clinically relevant or progressive retinal disease. History of intraocular trauma or surgery within the past six months. Patients with less than 30 days stable dosing regimen before the Screening Visit of any non-glaucoma medications. History of, or current bronchial asthma, severe chronic obstructive pulmonary disease, or severe unstable or uncontrolled cardiovascular, hepatic or renal disease. Patients with best-corrected visual acuity worse than 0.6 logMAR score in either eye. Patients with angle grade less than Grade 2 measured by gonioscopy. Patients with a cup/disc ratio greater than 0.80 in either eye. Additionally, the Medical Monitor may declare any patient ineligible for a valid medical reason. |
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E.5 End points |
E.5.1 | Primary end point(s) |
The primary statistical objective of this study is to demonstrate that the IOP-lowering efficacy of dosing Travoprost 0.004 /Timolol 0.5 Ophthalmic Solution once-daily morning dosing is superior to Dorzolamide 2 /Timolol 0.5 Ophthalmic Solution, dosed twice-daily. |
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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 | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | Information not present in EudraCT |
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 | Information not present in EudraCT |
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 | Yes |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
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.8.5 | 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 | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
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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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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 | 8 |
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 | 8 |