E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Treatment-Naïve Patients with Open Angle Glaucoma at High Risk of Glaucomatous Progression. |
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MedDRA Classification |
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 |
Evaluate the efficacy and safety of bimatoprost/timolol fixed combination vs. latanoprost in patients with elevated intraocular pressure (IOP) and risk factors for glaucoma progression after 3 months of treatment. |
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E.2.2 | Secondary objectives of the trial |
? Mean change from Baseline IOP (Day 0) at 8.00, 12.00 and 16.00 hr at 3 months. ? Percentage of patients that reach a predefined target pressure threshold at 3 months. ? Mean of the absolute difference between patient?s highest IOP reading at Baseline (Day 0) and the corresponding IOP reading at 3 months. ? Mean of the absolute difference between patient?s lowest IOP reading at Baseline (Day 0) and the corresponding IOP reading at 3 months. ? Safety assessments. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. Male or Female Patients aged >18 years and < 85 years. 2. Patients suffering from treatment-naïve, primary open-angle glaucoma with a baseline IOP ?27 mmHg and ? 34 mmHg in one or both eyes at any of the assessment timepoints (the eye with the higher IOP will be the study eye or if both eyes are the same pressure, the right eye will be the study eye). 3. Patients with at least one of the following risk factors: pseudoexfoliation (PEX), family history of glaucoma, pigment dispersion, optic disc haemorrhages, visual field mean deviation > -6dB, both eyes with an IOP >27mmHg. 4. Best corrected visual acuity (BCVA) (Snellen equivalent: 20/60 in each eye). 5. Patients who are treatment-naïve to ocular hypotensive medications. 6. Patients willing to participate in the study for the whole duration of the study through to follow-up, who are legally able and who have given informed consent to participate in the study. 7. Patient is able to follow study instructions and likely to complete all required visits. 8. Two reliable visual field tests: one performed within 6 months prior to the Baseline (Day 0) visit and a confirmatory test on Baseline (Day 0) prior to randomisation. |
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E.4 | Principal exclusion criteria |
1. History of refractive surgery. 2. History of intraocular surgery performed less than 3 months from Baseline (Day 0). 3. A visual field defect that in the opinion of the physician, medical intervention for the patient is necessary. 4. Contraindication to ?-adrenoceptor antagonist therapy including but not limited to: chronic obstructive pulmonary disease (COPD), bronchial asthma or a history of bronchial asthma, sinus bradycardia, second or third degree atrioventricular block, history of severe myocardial infarction or clinically relevant low or high heart (pulse) rate or blood pressure. 5. Known allergy or sensitivity to the study medication(s) or its components. 6. Current ocular inflammation or infection, or history of ocular inflammation or infection in the past three months. Patients with history of uveitis are to be excluded. (Mild blepharitis is acceptable). 7. Corneal abnormalities, in either eye, that would preclude accurate IOP readings with an applanation tonometer. 8. Any history of ocular trauma, in either eye, in the last six months. 9. Contact lens wearers can be included but contact lenses should be removed prior to administration of study product and with at least a 15-minute wait before reinsertion. 10. Required chronic use of other ocular medications, in either eye, during the study other than the study medications. Occasional use of artificial tear products and topical antihistamines is allowed. 11. Intermittent use of oral, injectable or topical ophthalmic steroids within 21 days prior to the Baseline visit (day 0) or anticipated use during the study. 12. Female patients who are pregnant, nursing, or planning a pregnancy, or females of childbearing potential not using a reliable means of contraception. A female is considered of childbearing potential unless she is post-menopausal or without a uterus and/or both ovaries. (NB: A pregnancy test will be performed at Visit 1 for all females of childbearing potential to confirm the patient is not pregnant prior to randomisation). 13. Current enrolment in any investigational drug or device study, or participation within 30 days of Baseline (Day 0). 14. Patient has a condition or is in a situation which, in the Investigator?s opinion, may put the patient at significant risk, may confound the study results, or may interfere significantly with the patient?s participation in the study. |
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E.5 End points |
E.5.1 | Primary end point(s) |
? Mean change from baseline (Day 0) average IOP (08.00, 12.00 and 16.00 hrs) at 3 months |
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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 | 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 | Information not present in EudraCT |
E.7.1.2 | Bioequivalence study | Information not present in EudraCT |
E.7.1.3 | Other | Information not present in EudraCT |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
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 | Yes |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
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 | 3 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 12 |
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
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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 | 9 |
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 | 9 |
E.8.9.2 | In all countries concerned by the trial days | 0 |