E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Open-angle glaucoma or ocular hypertension |
|
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | SOC |
E.1.2 | Classification code | 10015919 |
E.1.2 | Term | Eye disorders |
|
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 |
|
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 | 10030043 |
E.1.2 | Term | Ocular hypertension |
|
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 evaluate the effect on mean nocturnal IOP of the fixed combination Travoprost/Brinzolamide dosed once-daily in the evening versus TRAVATAN dosed once-daily in the evening, in patients with open-angle glaucoma or ocular hypertension. |
|
E.2.2 | Secondary objectives of the trial |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
18 yrs of age or older. Either Sex. Open-angle glaucoma or ocular hypertension. Patients inadequately controlled on a urrent stable (i.e., at least 4 weeks) IOP lowering medication. Mean IOP (at Eligibility Visit 9AM) >= 24 mmHg. Mean IOP (Screening, Eligibility, 24-hour baseline visit) <= 32 mmHg at any time-points. Able to discontinue use of all IOP-lowering medication(s) for a minimum period of 4 days to a maximum of 35 days prior to the 24-hour Baseline Visit. |
|
E.4 | Principal exclusion criteria |
Female of childbearing potential unless strict conditions are respected. Severe central visual field loss. Angle grade < 2. Cup/disc ratio > 0.8 in either eye. Current ocular infection or inflammation, or history of ocular infection or inflammation within the past 3 months. Intraocular surgery or history of ocular trauma within the past 6 months. Ocular laser surgery in either eye within the past 3 months. Best-corrected VA worse than 55 letters read. Any abnormality preventing reliable tonometry. Current chronic, recurrent or severe inflammatory eye disease (e.g., scleritis, uveitis, herpes keratitis), or current other severe ocular pathology (including severe dry eye) in either eye that would affect the conduct of the study. History of or current clinically relevant or progressive retinal disease such as retinal degeneration, diabetic retinopathy or retinal detachment in either eye. Unable to discontinue glucorticoid 4 weeks prior to the study and not use during the study. Allergy/hypersensitivity to study medication. Less than 30 days stable dosing regimen of medications used on a chronic basis than may affect IOP. Patients likely to be put on any additional ocular or systemic ocular hypotensive medication during the course of the study. Oral CAI. Recent use (< 4 weeks prior to the study) of Aspirin (> 1 gram). Significant disturbances of wake-sleep rhythms and/or who consume hypnotic drugs on a regular basis. |
|
E.5 End points |
E.5.1 | Primary end point(s) |
Mean nocturnal IOP (midnight, 3:00 and 6:00) |
|
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 | No |
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 | Yes |
E.6.13.1 | Other scope of the trial description |
abbassamento circadiano della PIO |
|
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) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
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 | 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) | Information not present in EudraCT |
E.8.2.2 | Placebo | Information not present in EudraCT |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
- same IMP used at different dosage |
|
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 | No |
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
| |
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 | |
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 |