E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Open-angle glaucoma (with or without pseudoexfoliation or pigment dispersion component) 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 | HLGT |
E.1.2 | Classification code | 10018307 |
E.1.2 | Term | Glaucoma and ocular hypertension |
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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 efficacy and safety of DuoTrav APS to DuoTrav, both dosed once-daily in the morning, in patients with open angle glaucoma or ocular hypertension. |
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E.2.2 | Secondary objectives of the trial | |
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
- Patients of either sex and any race ,of 18 years of age or older. - Patients diagnosed with open-angle glaucoma (with or without pseudoexfoliation or pigment dispersion component) or confirmed ocular hypertension who would benefit from a fixed combination medication, in the opinion of the Investigator. - Patients currently on a stable treatment (i.e., at least 30 days) with an IOP-lowering medication. - Patients must meet the following IOP entry criteria in at least one eye at Eligibility Visits 1 & 2: • Mean IOP ≥ 24 mmHg at the 09:00 time point, and • Mean IOP ≥ 21 mmHg at the 11:00 and 16:00 time points. • The mean IOP in either eye at Screening or Eligibility must not be greater than 36 mmHg at any time point. The mean IOP is the average of IOP measurements in the same eye, as described in Section 9.4.7. The same eye(s) must qualify at all qualifying time points. - Only patients who satisfy all Informed Consent requirements may be included in the study. |
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E.4 | Principal exclusion criteria |
- Pregnancy or females of childbearing potential not taking adeqaute birth control measures - Any form of glaucoma other than open-angle glaucoma (with or without pigment dispersion or pseudoexfoliation component) or confirmed ocular hypertension - Iridocorneal angle Shaffer grade < 2 (extreme narrow angle with complete or partial closure) in either eye, as measured by gonioscoy - Cup/Disc ratio greater than 0.80 (horizontal or vertical) in either eye - Severe central visual field loss in either eye - 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 (equivalent to approximately 20/80 Snellen, 0.60 logMAR or 0.25 decimal) - Current ocular infection or inflammation, or history of ocular infection or inflammation within the past 3 months as determined by patient history and/or eye examination. - History of, or current clinically relevant (in the opinion of the Investigator) or progressive retinal disease such as retinal degeneration, diabetic retinopathy, or retinal detachment. - Any abnormality preventing reliable applanation tonometry. - 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 or current bronchial asthma, or severe chronic obstructive pulmonary disease that would preclude the safe administration of a topical beta-adrenergic blocking agent. - History of or current severe, unstable or uncontrolled cardiovascular, hepatic, or renal disease (e.g., sinus bradycardia, overt cardiac failure, greater than first degree atrioventricular block, cardiogenic shock, clinically relevant angina or uncontrolled hypertension) that would preclude the safe administration of a topical beta-adrenergic blocking agent. - History of spontaneous or current hypoglycemia or uncontrolled diabetes. - History of or current severe allergic rhinitis and bronchial hyper reactivity. - History of or current corneal dystrophies. - History of severe or serious hypersensitivity to prostaglandin drugs or their analogues, beta-adrenergic blocking agents, or to any components of the study medications. - Patients who are unable, in the opinion of the Investigator, to safely discontinue use of all IOP-lowering medication(s) during the washout period. - Less than 30 days stable dosing regimen before the Screening Visit of any medications or substances administered by any route and used on a chronic basis that may affect IOP, including, but not limited to, beta-adrenergic blocking agents. Note: Patients must be on a stable dosing regimen of these medications for at least 30 days prior to the Screening Visit and must not change the dosing regimen during the eligibility period with the exception of a substitution of the patient’s current ocular hypotensive medication for one requiring a shorter washout period. Note: Patients using non-prescription and/or prescription topical ophthalmic medications that do not affect IOP may be included in the study. - Use of any additional topical or systemic ocular hypotensive medication during the study. - 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 of intermittent glucocorticoid medications for at least 2 weeks before the Eligibility 1 Visit, and must be able to remain off these medications for the duration of the study. - Patients who are currently on therapy or were on therapy with another investigational agent within 30 days prior to the Screening Visit. - Patients not willing to complete all required study visits. - Patients who are unwilling to remove their contact lenses prior to instillation of the study medication and to leave them out for a minimum of 15 minutes following instillation before reinserting the lenses. - 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) |
Mean IOP at 9.00, 11.00 and 16.00 time points at Month 3 |
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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 | 2 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 5 |
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 | |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 1 |