E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated | |
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 | 10010486 |
E.1.2 | Term | Congenital 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 |
The primary objective is to assess the relative effectiveness of latanoprost 0.005% ophthalmic solution dosed once daily and timolol 0.5% dosed twice daily in paediatric subjects ≤18 years of age who are diagnosed with glaucoma. Specifically, to demonstrate that latanoprost is not inferior to timolol within a non inferiority margin of 3 mm Hg, with an option of switching to superiority, in the event that the lower limit of the 95% confidence interval for the treatment difference not only lies above the non inferiority margin but also above zero. |
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E.2.2 | Secondary objectives of the trial |
To evaluate the safety of latanoprost 0.005% ophthalmic solution dosed once daily and timolol 0.5% dosed twice daily in paediatric subjects ≤18 years of age who are diagnosed with glaucoma. To compare latanoprost 0.005% ophthalmic solution dosed once daily and timolol 0.5% dosed twice daily in paediatric subjects ≤18 years of age who are diagnosed with glaucoma, with respect to the proportion of patients with at least a 15% lowering of baseline IOP (responder analysis).
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. Are male or female ≤18 years of age (neonates are required to be at least 36 weeks gestational age); 2. Have a diagnosis of paediatric glaucoma; 3. Require pharmacological intervention with IOP reducing therapy in at least 1 eye; 4. Have a morning (before mid day) baseline visit IOP >22 mmHg in at least 1 eye; 5. Are on topical therapy or are naïve to pharmacologic treatment; 6. Have signed and dated an informed consent document indicating that subject’s parent (or legal guardian) had been informed of all pertinent aspects of the study. A signed and dated assent will be required where applicable according to local laws. 7. Are willing and able to comply with scheduled visits (parent or legal guardian). |
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E.4 | Principal exclusion criteria |
1. Require surgery for acute angle closure or closed or a narrowly open anterior chamber angle; 2. Have failed previous long term therapeutic intervention with either timolol or a prostaglandin to control elevated IOP; 3. Have had prior cyclodestructive procedures; 4. Cannot expect reasonable improvement by pharmacologic treatment, which is given in addition to filtering surgeries (eg, trabeculectomy) or drainage implants (history of surgery or implant is not the condition of exclusion); 5. Have or have had other medical condition(s) in which treatment with beta blocking agents are contraindicated such as heart failure, sinus bradycardia, second and third degree atrio ventricular block, bronchial asthma or history thereof, and obstructive pulmonary disease; 6. Have ocular inflammation/infection or a history of ocular inflammation/infection within 3 months prior to the baseline visit; 7. Have a history of ocular trauma or surgery in either eye within 1 month of the baseline visit; 8. Have a history of allergy to any of the ingredients contained in the study medications (eg, hypersensitivity to benzalkonium chloride, or to any other component in Xalatan and or timolol); 9. Have any corneal condition that would prevent tonometric measurements; 10. Have, or have had a history of chronic allergic conjunctivitis, chronic keratitis or lacrimal deficiency; 11. Have taken systemic and/or ocular steroids within 1 month of the baseline visit (eg, prednisolone drops); 12. Anticipate the need to initiate or modify medication (systemic or topical) that is known to affect IOP during the study period; 13. Have, or have had a history of any other severe acute or chronic medical or psychiatric condition that could increase the risk associated with study participation or could interfere with the interpretation of study results and, in the judgment of the investigator, could make the subject inappropriate for entry into this study; 14. Have used an investigational drug or device within 30 days of the baseline visit; 15. Is pregnant or nursing females; [menarchal females of child bearing potential (females age 10 or greater, or who are menarchal) must have a negative pregnancy test, and those who are unwilling or unable to follow the instruction to avoid pregnancy, from at least 14 days prior to the first dose of trial mediation until completion of follow up procedure, will not participate to the trial.] (proper methods to avoid pregnancy should be instructed at the entrance of the study). |
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E.5 End points |
E.5.1 | Primary end point(s) |
Mean change from baseline IOP in the study eye at Week 12 (last observation on masked treatment carried forward for switchers) |
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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 | 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
| Information not present in EudraCT |
E.8.4 | The trial involves multiple sites in the Member State concerned | Information not present in EudraCT |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 52 |
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 | |
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 |
E.8.9.2 | In all countries concerned by the trial months | 3 |
E.8.9.2 | In all countries concerned by the trial days | 4 |