E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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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 | 10037118 |
E.1.2 | Term | Pseudoexfoliation glaucoma |
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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 |
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 area under the diurnal IOP curve (measured at 8am, 11am, 2pm 5pm and 8pm) after Ganfort and Duotrav treatment (three months after start of respectively treatment). |
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E.2.2 | Secondary objectives of the trial |
To compare the following endpoints between the Ganfort and the Duotrav treatment: − Diurnal IOP change from baseline until three months after start of each treatment (for each time point separately) − IOP change from baseline at one month after start of each treatment − Diurnal IOP change from baseline after switch to the other therapy − Diurnal IOP response in POAG vs PEX patients respectively (subgroup analysis) − Target mean IOP (i.e. a patient is denoted a responder if the target mean IOP, as pre defined by the investigator prior to study start, is reached) − Safety (in terms of reported ocular side effects and adverse events on each treatment)
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1) The patient is suffering from POAG or PEX (If the patient has glaucoma and high IOP in both eyes, both eyes will be treated but the worst eye chose for the statistical analysis). Glaucoma definition is based on the European Glaucoma Society Guidelines. 2) The patient is on either a non-fixed combination of Xalatan and Timolol for at least 3 months or on Xalacom for at least 6 month 3) The patient has an IOP<21 mm Hg at the 8am time point.. 4) The patient has not reached the target IOP as set by the treating physician
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E.4 | Principal exclusion criteria |
1) Unwilling to sign informed consent 2) Not at least 18 years old 3) Beta blockers are contraindicated 4) Ocular condition that are of safety concern and that can interfere with the study results 5) Closed/barely open anterior chamber angles or history of acute angle closure. 6) Ocular surgery or argon laser trabeculoplasty within the last three months. 7) Ocular inflammation/infection occurring within three months prior to pre-trial visit. 8) Neurovascular Patients (including diabetic patients with neovascular glaucoma) 9) Concominant topical ocular medication that can interfere with study medication 10) Hypersensitivity to benzalkonium chloride or to any other component of the trial drug solutions. 11) Other abnormal condition or symptom preventing the patient from entering the trial, according to the Investigator's judgement. 12) Refractive surgery patients 13) Women who are pregnant, are of childbearing potential and are not using adequate contraception or are nursing. 14) Inability to adhere to treatment/visit plan. 15) 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 the area under the diurnal IOP curve (AUC) (measured at 11am, 2pm 5pm, 8pm and 8am) after Ganfort or Duotrav treatment (three months after start of respective treatment) |
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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 | 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 | No |
E.8.1.6 | Cross over | Yes |
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 | 1 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 7 |
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 | 0 |
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 | 0 |
E.8.9.2 | In all countries concerned by the trial days | 0 |