E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Xalatan is indicated for the reduction of elevated intraocular pressure (IOP) in subjects with open-angle glaucoma or ocular hypertension. |
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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 | 10018304 |
E.1.2 | Term | 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 evaluate the steady-state systemic plasma concentrations of latanoprost acid following administration of latanoprost 0.005% (1.5 μg) in pediatric and adult subjects with glaucoma or ocular hypertension. |
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E.2.2 | Secondary objectives of the trial |
To assess the safety and tolerability of latanoprost 0.005% in pediatric subjects. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
male or female subjects of any age with glaucoma or ocular hypertension, receiving treatment with latanoprost 0.005% in one or both eyes for a minimum of 2 weeks. evidence of signed and dated an informed consent document indicating that the subject or the subjects parent (or legal guardian) has been informed of all pertinent aspects of the study. A signed and dated assent will be required where applicable according to local laws and regulations. willing and able to comply with scheduled visits, treatment plan, and other study procedures (subject and for minors, parent/legal guardian). females of childbearing potential (post-menarchal females) must have a negative urine pregnancy test at screening or on the study day (prior to dosing). |
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E.4 | Principal exclusion criteria |
ocular inflammation/infection or a history of ocular inflammation/infection within 3 months prior to the screening visit. history of ocular trauma or surgery in either eye within 3 months of the screen visit. history of hypersensitivity to latanoprost, benzalkonium chloride, or any other ingredients contained in Xalatan. use of continuous wear contact lenses. pregnant or nursing females; sexually active females of childbearing potential who are unwilling or unable to use an acceptable method of contraception as outlined in this protocol from at least 14 days prior to the dose of study medication until 28 days after dosing. evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing). history of febrile illness within 5 days prior to the start of the study. other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the subject inappropriate for entry into this study. treatment with an investigational drug within 30 days or 5 half-lives preceding the first day of study. history of regular alcohol consumption exceeding 14 drinks/week for females or 21 drinks/week for men (1 drink = 5 ounces (150 mL) of wine or 12 ounces (360 mL) of beer or 1.5 ounces (45 mL) of hard liquor) within 6 months of screening. use of tobacco- or nicotine-containing products in excess of the equivalent of 5 cigarettes per day. blood donation of approximately 1 pint (500 mL) within 56 days prior to dosing. |
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E.5 End points |
E.5.1 | Primary end point(s) |
Plasma latanoprost acid concentrations at steady-state. Adverse events related to systemic exposure of latanoprost. |
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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 | Yes |
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 |
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E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | Yes |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | Yes |
E.7.1.3.1 | Other trial type description |
Autorizzazione impiego in pazienti pediatrici |
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E.7.2 | Therapeutic exploratory (Phase II) | No |
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 | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
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) | Information not present in EudraCT |
E.8.2.2 | Placebo | Information not present in EudraCT |
E.8.2.3 | Other | Information not present in EudraCT |
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 | 8 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
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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 | 0 |
E.8.9.1 | In the Member State concerned months | 8 |
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 | 8 |