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.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | SOC |
E.1.2 | Classification code | 10015919 |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10030043 |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10030348 |
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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 |
To compare the IOP-lowering efficacy and the safety over 12 months of morning or evening instillations of Travoprost/Brinzolamide versus COSOPT dosed in the morning and evening, 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 | No |
E.3 | Principal inclusion criteria |
Patients of either sex and any race, 18 years of age or older, diagnosed with open-angle glaucoma (with or without pseudoexfoliation or pigment dispersion component) or ocular hypertension. Patients inadequately controlled (i.e., with a mean IOP >= 18 mmHg in at least one eye at Screening) on a current stable, i.e., at least 4 weeks, IOP lowering medication. Patients must meet the following IOP entry criteria in at least one eye: for each qualifying eye, the mean IOP must be >= 24 and <= 36 mmHg at the 9 time point, and >= 21 and <= 36 mmHg at the 11 and 16 time points. The same eye(s) must qualify at all qualifying time points at both Eligibility Visits 1 and 2. The mean IOP is the average of IOP measurements in the same eye. Patients must be able to discontinue use of all IOP-lowering medication(s) for a minimum period of 5 days to 28 days prior to Eligibility Visit 1. |
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E.4 | Principal exclusion criteria |
Females of childbearing potential (those who are not surgically sterilized or at least two years post-menopausal) are excluded from participation in the study if they meet the conditions described in the protocol. Patients with any form of glaucoma other than open-angle glaucoma (with or without pigment dispersion or pseudo-exfoliation component) or confirmed ocular hypertension. Patients with iridocorneal angle Shaffer grade < 2 in either eye, as measured by gonioscopy. Patients with a cup/disc ratio greater than 0.80 (horizontal or vertical measurement)in either eye. Patients with severe central visual field loss in either eye. Severe central field loss is defined as a sensitivity of <= 10 dB in at least 2 of the 4 visual field test points closest to the point of fixation. History of, or current chronic, recurrent, or severe inflammatory eye disease (e.g., scleritis, uveitis, herpes keratitis), or current other severe ocular pathology (including severe dry eye) that would affect the conduct of the study. History of ocular trauma within the past 6 months. Intraocular surgery within the past 6 months. Ocular laser surgery within the past 3 months. Best-corrected visual acuity score worse than 55 ETDRS letters read (equivalent to approximately 20/80 Snellen or 0.25 decimal or 0.6 logMAR). Current ocular infection or inflammation, or history of ocular infection or inflammation within the past 3 months, as determined by patients history and/or examination. History of, or current clinically relevant, or progressive retinal disease such as retinal degeneration, diabetic retinopathy, or retinal detachment. Any corneal abnormality preventing reliable applanation tonometry. History of, or current severe, unstable or uncontrolled cardiovascular, hepatic or renal disease that would preclude the safe administration of a topical beta-blocker. History of, or current bronchial asthma, or severe chronic obstructive pulmonary disease that would preclude the safe administration of a topical beta-blocker. History of, or current evidence of severe illness or any other conditions which would make the patient, in the opinion of the Investigator, unsuitable for the study. History of severe or serious hypersensitivity to prostaglandin analogues, to CAIs, to beta-blockers or to any components of the study medications. Patients likely to use additional topical or systemic ocular hypotensive medication during the study. Patients who cannot safely discontinue all glucocorticoid medications administered by any route. Recent (within 4 weeks of Eligibility 1 Visit) use of high dose (> 1 gram daily) salicylate therapy. History of uncontrolled diabetes or hypoglycemic episodes. |
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E.5 End points |
E.5.1 | Primary end point(s) |
The primary efficacy parameter (end point) is mean IOP at the 9, 11 and 16 time points at Month 12. |
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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 | No |
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 | 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.8.4.1 | Number of sites anticipated in Member State concerned | 6 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 43 |
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 | 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
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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 | 1 |
E.8.9.1 | In the Member State concerned months | 6 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 2 |
E.8.9.2 | In all countries concerned by the trial months | 11 |