E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
ocular hypertensive or glaucomatous patients |
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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 | 10030043 |
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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 |
Change in IOP at 9.00 am (� 1 hour) between the baseline Day 0 and Day 84 in the worse eye (or in the right eye in case of no IOP difference between both eyes). |
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E.2.2 | Secondary objectives of the trial |
Secondary clinical efficacy criteria - Change in IOP between Day 0 and 84 in the controlateral eye (if applicable). - Change in IOP between Day 0 and 15: in the worse eye, in the controlateral eye (if applicable). - Change in IOP between Day 0 and 42: in the worse eye, in the controlateral eye (if applicable). - Global efficacy assessed by the investigator on Day 15, 42 and 84. Ocular and systemic safety criteria - Objective ocular signs at the Slit Lamp Examination at Day 15, 42 and 84. - Ocular symptoms upon instillation at Day 15, 42 and 84. - Other ocular symptoms at Day 15, 42 and 84. - Best far corrected visual acuity at Day 84. - Visual Field test, if performed at Day 84. - Fundunscopy, if performed at Day 84. - Global tolerance assessed by the investigator at Day 15, 42 and 84. - Global tolerance assessed by the patient at Day 15, 42 and 84. - Adverse events recorded from Day 0 and throughout the study. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Patients will be eligible for inclusion if all these criteria are respected: At Selection Visit: - Signed and dated informed consent, - Male or female aged from ≥ 18 to ≤ 90 years old, - Association of the following criteria for the eligible eye(s): - Chronic primary open angle glaucoma or chronic ocular hypertension - Already treated and controlled (since at least one year) by a monotherapy of Xalatan defined by: Stable IOP (≤ 18 mmHg), And Stable visual field defined by two available visual field: the penultimate visual field performed within the last 18 months the last visual field performed within the last 6 months and with an interval of at least 6 months between both visual fields. - Corneal thickness ≥ 510 Mm and ≤ 560 Mm. At Inclusion Visit: - IOP: IOP < 34 mmHg in BOTH eyes And IOP ≥ 22 mmHg in the eligible eye(s). |
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E.4 | Principal exclusion criteria |
Ophthalmic non-inclusion criteria (in either eye) - Any secondary ocular hypertension. - Any severe glaucoma defined by study . - BCVA minor or equal to 1/10. - Aphakia. - Known history of ocular allergy and/or blepharitis and/or uveitis, traumatism, infection, ocular inflammation within the 3 months before the selection Visit, refractive surgery. - Severe dry eye. - Any abnormality preventing accurate assessment. Systemic/non ophthalmic non-inclusion criteria - General history: Non controlled asthma, Any medical or surgical history, disorder or disease and/or any complicating factor or structural abnormality, judged by the investigator to be incompatible with the study. - Known allergic hypersensitivity history to one of the components of the study medications or to test products. Specific non-inclusion criteria for women - Pregnancy, lactation, women without an effective method of contraception or women not hysterectomised, menopaused or surgically sterilized. Non-inclusion criteria related to general conditions - Inability of patient and/or relatives to understand the study procedures and thus inability to give informed consent. - Non compliant patient and/or relatives. - Participation in another clinical study within the last 3 months. - Already included once in this study. - Ward of court. - Patient not covered by the Social Security scheme when existing in the concerned country (NA in Italy). |
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E.5 End points |
E.5.1 | Primary end point(s) |
Efficacy - IOP recorded in each eye at 9.00 am (+/- 1h), on D-42, D0, D15, D42, and D84. At each timepoint 2 recordings are performed. If these differ by more than 2 mm Hg then a third recording is performed. The average of the 2 or 3 recordings is calculated. The analysis is performed on the basis of the average IOP. - Global efficacy assessed by the investigator on a 4 point ordinal scale on D15, D42 and D84. |
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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 | Yes |
E.6.13.1 | Other scope of the trial description |
studio di non inferiorita` |
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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 | 5 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 65 |
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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La sperimentazione si conclude con la Last Patient Last Visit (ultima visita dell`ultimo soggetto inserito). |
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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 | 12 |
E.8.9.1 | In the Member State concerned days | |
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 | 12 |