E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
patients with a diagnosis of open-angle glaucoma or ocular hyperthension |
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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 | LLT |
E.1.2 | Classification code | 10030348 |
E.1.2 | Term | Open angle glaucoma |
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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 safety and efficacy IOP- lowering efficacy of Brinzolamide 1.0 /Timolol 0.5 ophtalmic suspension to COSOPT in patients witha a diagnosis of 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 |
-written informed consent, availability to satisfy the requirements of the informed consent - Patients, 18 years of age or older, diagnosed with open-angle glaucoma with or without pseudoexfoliation or pigment dispersion component or ocular hypertension who are currently on an IOP-lowering medication and, in the opinion of the investigator, would benefit from a combination therapy. -Patients must meet the following IOP entry criteria in at least one eye For each qualifying eye, the mean IOP must be 24 to 36 mmHg at 8 00 AM at both Eligibility Visits 1 and 2. For each qualifying eye, the mean IOP must be 21 to 36 mmHg at 10 00 AM at both Eligibility Visits 1 and 2. The mean IOP in either eye at any time point during Eligibility Visits 1 and 2 must not be greater than 36 mmHg. The same eye s must qualify at both Eligibility Visits 1 and 2. -Patients who wear contact lenses will be allowed to participate in the study provided that the contact lenses are removed before instillation of study medication, and that the patient waits a minimum of 15 minutes following drug instillation before re-inserting the lenses. Patients who wear contact lenses will be instructed to wear or bring their glasses with them on study visit days. - Patients using nonprescription and/or prescription topical ophthalmic and/or systemic non-IOP lowering medications except for those in the Exclusion Criteria may be included in the study. |
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E.4 | Principal exclusion criteria |
- Females of childbearing potential are excluded if they meet any one of the following conditions They are currently pregnant or, They have a positive result on the urine pregnancy test at the Screening Visit or,they intend to become pregnant during the study period or,they are breast-feeding or,they are not using highly effective birth control measures. Patient who are chilbearing potential must consent to a urine pregnancy test at screening visit, at month 6 visit and at exit visit. - Patients with any form of glaucoma other than open-angle glaucoma with or without a pigment dispersion or pseudoexfoliation component or ocular hypertension. - Patients who are currently on therapy or were on therapy with another investigational agent within 30 days prior to the Screening Visit. - History of chronic, recurrent or current severe inflammatory eye disease in either eye. - History of ocular trauma within the past six 6 months in either eye. - History of or current ocular infection or ocular inflammation within the past three 3 months in either eye. History of or current clinically significant or progressive retinal disease such as retinal degeneration, diabetic retinopathy, or retinal detachment in either eye. - History of or current other ocular pathology including severe dry eye , in either eye, that would preclude the safe administration of a sulfonamide analogue. - History of severe or serious hypersensitivity to timolol maleate, topical or oral carbonic anhydrase inhibitors, sulfonamide derivatives, or to any components of the study medications - Intraocular surgery within the past 6 months as determined by patient history and/or examination in either eye. - Ocular laser surgery within the past 3 months as determined by patient history and/or examination in either eye. -Any abnormality preventing reliable applanation tonometry of either eye. -Patients with best-corrected visual acuity worse than 0.60 logMAR score in either eye. - Patients with angle grade less than Grade 2 in either eye, as measured by gonioscopy extreme narrow angle with complete or partial closure The cup/disc ratio is measured on both the vertical and horizontal axis. Patients are excluded if the cup/disc ratio is greater than 0.80 in either eye on the horizontal or vertical measurement. - Patients with severe central visual field loss in either eye. Severe central visual field loss is defined as a sensitivity of less than or equal to 10 dB in at least 2 of the 4 visual field test points closest to the point of fixation. - Patients who cannot safely discontinue use of all ocular IOP-lowering medication s for a minimum period of 5 days 1 day to twenty-eight 28 days 1 day prior to Eligibility 1 Visit. - Use of any additional topical or systemic ocular hypotensive medication during the study. - Recent within 4 weeks of the Eligibility 1 Visit use of high-dose 1 gram daily salicylate therapy. - History of spontaneous or current hypoglycemia or uncontrolled diabetes. -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. - Patients who cannot safely discontinue all glucocorticoid medications administered by any route. - Patients must have washed out of chronic glucocorticoid medications for at least 4 weeks, or intermittent glucocorticoid therapy for at least two weeks prior to the Eligibility 1 Visit, and must be able to remain off these medications for the duration of the study.- Patients with less than 30 day stable dosing regimen before the Screening Visit of any medications or substance administered by any route and used on a chronic basis that may affect IOP measurement. |
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E.5 End points |
E.5.1 | Primary end point(s) |
To compare the safety and efficacy IOP- lowering efficacy of Brinzolamide 1.0 /Timolol 0.5 ophtalmic suspension to COSOPT in patients witha a diagnosis of open-angle glaucoma or ocular hypertension. |
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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 | 1 |
E.8.9.1 | In the Member State concerned months | 4 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 1 |
E.8.9.2 | In all countries concerned by the trial months | 4 |