E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Primary Open Angle Glaucoma 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 | PT |
E.1.2 | Classification code | 10022806 |
E.1.2 | Term | Intraocular pressure increased |
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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 |
1. To determine the extent to which GANfort®can reduce IOP in patients presenting with significantly elevated IOP at the 10 am IOP measurement.. 2. To determine the diurnal IOP control achieved with GANfort®
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E.2.2 | Secondary objectives of the trial |
1. Local and systemic side effect profile of medications 2. To determine the effectiveness of a uniocular drug trial in prediction of IOP lowering in the second treated eye with GANfort® when both the eyes require treatment(9, 10).
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. Newly diagnosed open angle glaucoma (OAG) or ocular hypertension(OHT) patients with IOPs ³ 25mmHg at presentation and on baseline assessment. 2. OAG and OHT patients presently treated for their raised IOP and willing to undergo a washout period of no medication prior to starting GANfort® 3. No contraindications to any of components of GANfort®
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E.4 | Principal exclusion criteria |
1.1. Unwilling to sign informed consent 2. Patients in whom Beta blockers are contraindicated 3. Patient with a history of severe cardiac disease or overt cardiac failure 4. Sinus Bradycardia, second or third degree Atrioventricular blockPatient with severe asthma, bronchospasm or COAD 5. Paediatric age group 6. Known hypersensitivity to any of the drug ingredients 7. Ocular condition that are of safety concern and that can interfere with the study results 8. Patients with macular oedema 9. Patients with neovascular glaucoma or angle closure glaucoma 10. Closed or narrow anterior chamber angles or history of acute angle closure. 11. Ocular surgery or argon laser trabeculoplasty within the last three months. 12. Ocular inflammation/infection occurring within three months prior to pre-trial visit. 13. Concominant topical ocular medication that can interfere with study medication 14. Other abnormal condition or symptom preventing the patient from entering the trial, according to the Investigator's judgement. 15. Refractive surgery patients at any time 16. Women who are pregnant, are of childbearing potential and are not using adequate contraception or are nursing. 17. Inability to adhere to treatment/visit plan. 18. Have participated in any other clinical trial (i.e., requiring informed consent) within one to three month prior to pre-trial visit (depending on ethics committee decisions).
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E.5 End points |
E.5.1 | Primary end point(s) |
The primary endpoint is IOP lowering 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 | 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) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
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) | No |
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
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.4.1 | Number of sites anticipated in Member State concerned | 1 |
E.8.5 | The trial involves multiple Member States | No |
E.8.5.1 | Number of sites anticipated in the EEA | 1 |
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 | 1 |
E.8.9.1 | In the Member State concerned months | 6 |
E.8.9.1 | In the Member State concerned days | 0 |
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 | 6 |
E.8.9.2 | In all countries concerned by the trial days | 0 |