E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Ocular Hypertension (IOP>22 mmHg), Primary Open Angle Glaucoma (mean defect between 0 and -12 db in a visual field) |
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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 |
E.1.2 | Term | Ocular hypertension |
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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 | 10036719 |
E.1.2 | Term | Primary 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 determine that the effectiveness and tolerability of Latanoprost RDR 0.005% Eye Drops Test Formulation is not inferior to Xalatan 0.005% Eye Drops. |
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E.2.2 | Secondary objectives of the trial | |
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
• written informed consent • male and female patients with unilateral or bilateral OH (defined by an IOP > 22 mmHg at several measurements) or POAG at an early stage (defined by a mean defect between 0 and -12 db in a visual field performed with an automated perimeter within the 3 months before the study) • age ≥ 18 years • with at least in one eye, IOP above or equal 22 mmHg at 8 am and below or equal 30 mmHg at 8 am, 12 noon and 4 pm under one of the following conditions: - patients with untreated OHT or - patients completing the 4-week washout period of an initial monotherapy with a prostaglandin or beta-blocker • patients whose initial therapy requires a washout may, upon decision of the investigator, be treated within this period by dorzolamide or a miotic, which will be stopped 1 week or 3 days, respectively, before study treatment initiation • best corrected visual acuity ≥ 20/100 (Snellen) or 2/10 (Monoyer) • female subjects must be using a medically accepted form of birth control and must have a negative urine pregnancy test at screening • able to provide informed consent after risks and benefits of the study have been explained • ability to communicate effectively with study personnel.
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E.4 | Principal exclusion criteria |
• in both eyes, IOP< 22 mmHg at 8 a.m. without any treatment or after a washout period • in the eye(s) to be treated, IOP > 30 mmHg at 8 a.m. or 12 noon or 4 p.m. • known sensitivity to latanoprost or any component of the drug products • use of contact lenses; • previous or active corneal disease; • monophthalmia; • history of macular oedema; • any intraocular infection or inflammation within the previous 3 months; • ocular surgery or severe trauma within the previous 3 months; • intraocular laser therapy within the last 3 months; • angle closure, congenital and secondary glaucoma (including pigmentary glaucoma); • ocular corticosteroids; • need of any other topical or systemic treatment of OH or POAG; • pregnancy or breastfeeding; • severe dysfunction of the liver or the kidneys; • active wasting disease including cancer; • angina pectoris not controlled by medical or surgical treatment; • severe asthma bronchiale (FEV1 < 70% of predicted value); • haematological diseases such as aplastic anaemia, pancytopenia, or haemolytic icterus; • current or anamnestic drug addiction or extensive alcohol use; • participation in another clinical study within 4 weeks prior to enrolment; • history of non-compliance; • any condition that compromises the ability to understand or comply with study requirements; • committed to an institution by virtue of an order issued either by the judicial or the administrative authorities.
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E.5 End points |
E.5.1 | Primary end point(s) |
The primary end point for the evaluation of the efficacy shall be the mean change of 8 a.m. IOP measured on the study eye from the baseline value to the end of the trial. |
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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) | 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 | 1 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 20 |
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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The last visit of the last trial subject. |
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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 | |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 1 |