E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
The study population will be suffering from open angle glaucoma or hypertension. |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 12.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10030348 |
E.1.2 | Term | Open angle glaucoma |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 12.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10030043 |
E.1.2 | Term | Ocular hypertension |
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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 assess the efficacy on IOP of T2345 (latanoprost 0.005% unpreserved eye drops) versus Xalatan (latanoprost 0.005% preserved eye drops) |
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E.2.2 | Secondary objectives of the trial |
Change in IOP between D0 and D84 in the controlateral eye (if applicable). Change in IOP between D0 and D15 in the worse eye and in the controlateral eye (if applicable). Change in IOP between D0 and D42 in the worse eye and in the controlateral eye (if applicable). Global efficacy assessed by the investigator on D15, D42 and D84. Objective ocular signs at the Slit Lamp Examination at D15, D42 and D84. Ocular symptoms upon instillation at D15, D42 and D84. Other ocular symptoms at D15, D42 and D84. Best far corrected visual acuity at D84. Visual Field test, if performed at D84. Fundunscopy, if performed at D84. Global tolerance assessed by the investigator at D15, D42 and D84. Global tolerance assessed by the patient at D15, D42 and D84. Adverse events recorded from D0 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 (for 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 with an interval of at least 6 months between both visual fields. Corneal thickness ? 510 µm and ? 560 µm.
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 |
Patients fulfilling at the selection visit ONE OR MORE of the following non inclusion criteria will not be included in the study: Ophthalmic non-inclusion criteria (in either eye): Any secondary ocular hypertension (such as congenital glaucoma, closed-angle glaucoma, secondary glaucoma, glaucoma after cataract surgery,?). Any severe glaucoma defined by: an advanced cupping AND/OR for the visual field: A severe field loss AND/OR A risk of visual field worsening as a consequence of participation in the trial according to the investigator?s best judgement AND/OR An absolute defect in the ten degree central point. Best far corrected visual acuity ? 1/10. Aphakia. Known history of ocular allergy and/or blepharitis and/or uveitis. History of traumatism, infection, ocular inflammation within the 3 months before the selection visit. History of refractive surgery. Severe dry eye (for example, clinically relevant superficial punctuate keratitis, epithelial erosions of the cornea and/or use of dry eye medication with a frequency exceeding 8 instillations/day). Any abnormality preventing accurate assessment e.g. reliable applanation tonometry, visual field examination.
Systemic/non ophthalmic non-inclusion criteria General history: Non controlled asthma. Any medical or surgical history, disorder or disease such as acute or chronic severe organic disease: hepatic, endocrine, neoplasic, haematological; immunosuppressive, infectious diseases, severe psychiatric illness, relevant cardiovascular abnormalities, etc 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 (oral contraceptive, intra-uterine device, subcutaneous contraceptive implant) or women not hysterectomised, menopaused or surgically sterilized. |
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E.5 End points |
E.5.1 | Primary end point(s) |
Change in IOP at 9.00 am (± 1 hour) between Day 0 (D0, baseline) and D84 (or the last attended visit after baseline) in the worse eye (or in the right eye in case of no IOP difference between both eyes). |
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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 | 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) | 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 | 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 | 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 | 7 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 60 |
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 |