E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Patients with Open-Angle Glaucoma or ocular hypertension |
Pazienti con Glaucoma ad angolo aperto o ipertensione oculare |
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E.1.1.1 | Medical condition in easily understood language |
Patients with Open-Angle Glaucoma or ocular hypertension |
Pazienti con Glaucoma ad angolo aperto o ipertensione oculare |
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E.1.1.2 | Therapeutic area | Diseases [C] - Eye Diseases [C11] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 23.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10084293 |
E.1.2 | Term | Unilateral glaucoma |
E.1.2 | System Organ Class | 100000004853 |
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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 |
Evaluate of the non-inferiority of preservative-free Latanoprost (Genetic Spa) as compared with Xalatan (Pfizer) in decreasing mean IOP (evaluated with Goldmann applanation tonometry) in subjects with POAG or OH after treatment for 6 months. |
Valutare la non inferiorità del Latanoprost senza conservanti (Genetic Spa) rispetto a Xalatan (Pfizer) nella diminuzione della IOP media (valutato con tonometro Goldmann) in soggetti con POAG o OH dopo un trattamento di 6 mesi. |
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E.2.2 | Secondary objectives of the trial |
The secondary objectives are the following: • to compare efficacy (mean IOP reduction) at months 1, and 3 months vs baseline. • to compare tolerability (assessed by V-14OSDI and OSDI) at month 1, 3 and 6 • to evaluate safety in patients treated with the study drug and comparator throughout the study follow-up period, with clinical assessments at 1, 3 and 6 months. |
Obiettivo Secondario: • Comparare l’efficacia (riduzione della IOP) ai mesi 3,6 vs baseline • Comparare la tollerabilità (valutata da OSDI) ai mesi 1,3 e 6. • Valutare la sicurezza in pazienti trattati con il farmaco in studio e il comparatore attraverso il periodo di follow-up, con una valutazione clinica ai mesi 1,3 e 6. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
A patient must meet all the following criteria to be eligible to participate in the study: 1 Adult patients (age =18 years). 2 Patients with unilateral or bilateral POAG or OH with IOP> 21 mm Hg.
• Group A) Patients who are naïve (never received any IOP-lowering medications) or • Group B) * Patients have: an inadequate response to, loss of response to, or are intolerant or responder in accordance to medical judgement to other IOP lowering agents (including Alpha adrenergic, Beta-blockers, Atropine, Inhibitor of Carbonic Anhydrase or combined medications). • Group C) *Patients who are taking Prostaglandin and or Prostaglandin Analogues 3 Patients have given written informed consent approved by the Ethical Review Board (ERB).
*Patients in Group B and C who are taking other medications will be randomized to begin the study treatment after a washout phase, as follows: A) Anticholinesterase agent (indirect acting): O a1-adrenergic antagonists: washout 4 weeks O ß-Adrenergic antagonists (ß-blockers plain and fixed combination,): washout 4 weeks B) Hyperosmotic Agent: O Parasympathomimetic agent washout 4 days O Prostaglandin Analogs (plain and fixed combination) washout 4 weeks C) Carbonic Anhydrase inhibitor: O Carbonic Anhydrase inhibitor: washout 7 days During the washout phase, all patients will receive a Carbonic Anhydrase inhibitor, which will be stopped one week before randomization. |
1) Pazienti adulti (età =18 anni) 2) Pazienti con POAG unilaterale o bilaterale o OH con IOP> 21 mmHg • Gruppo A Pazienti naïve (non hanno mai ricevuto alcun farmaco che diminuisce la IOP) o • Gruppo B)* Pazienti che hanno: una risposta inadeguata a, perdita di risposta a, o sono intolleranti o rispondenti secondo il giudizio medico ad altri agenti che abbassano la IOP (compresi Alfa adrenergici, Beta-bloccanti, Atropina, Inibitore dell'Anidrasi Carbonica o farmaci combinati) o Gruppo C) *Pazienti che stanno assumendo analoghi delle prostaglandine 3) Pazienti che hanno fornito il consenso informato scritto approvato dal Comitato di revisione etica *Patienti in Gruppi B and C che prendono altri farmaci che saranno randomizzati per iniziare il trattamento di studio dopo una fase di washout come segue: A. Agenti anticolinesterasici (azione indiretta): o Antagonisti ¿1-adrenergici: washout 4 settimane o Antagonisti ¿-Adrenergici (ß-blockers semplice e in combinazione fissa): washout 4 settimane B. Agenti iperosmotici: o Agenti Parasimpatomimetici washout 4 giorni o Analoghi delle Prostaglandine (semplice e in combinazione fissa) washout 4 settimane C. Inibitori dell’anidrasi Carbonica: o Inibitori dell’anidrasi Carbonica: washout 7 giorni Durante la fase di washout, tutti i pazienti riceveranno un inibitore dell’anidrasi carbonica, che verrà interrotto una settimana prima della randomizzazione |
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E.4 | Principal exclusion criteria |
A patient who meets any of the following criteria will be excluded from participating in the study: Ocular Conditions 1. Visual acuity of 20/200 or worse in one or two eyes. 2. Clinically significant or progressive retinal disease (e.g., degenerations, diabetic retinopathy, retinal detachment). 3. Severe OAG (MD higher than -12 dB in the worst eye) 4. Any laser or ocular surgery within 3 months prior screening 5. Hypersensitivity to prostagland.in analogues or ingredients of the study products (latanoprost, benzalkonium chloride) 6. Use of contact lenses 7. Closed anterior chamber angle or angle-closure glaucoma 8. Any ocular filtering procedure General Exclusions 9. Female patients: Pregnant, lactating or planning pregnancy within next 12 months. (Female of child-bearing potential will undergo pregnancy test; they will be required use two reliable contraceptive methods during the study - hormonal methods such as pill and condom) 10. Subject is currently participating in another investigational drug or device clinical trial that may interfere with the results of either trial. 11. Subjects legally or mentally incapacitated unable to give their informed consent for their participation in this study. 12. Vulnerable patients 13. Subjects who are unable or unwilling to comply with the appointments or with all the requirements of the Protocol. Medical Conditions 14. History of any chronic-neurodegenerative disease. 15. Inflammatory or infectious disease, active at the time of study entry. 16. Injuries or traumatisms not resolved at the time of admission to the study. 17. Positive substance abuse (illegal drugs). 18. Any condition that in the opinion of the investigator makes the patients unsuitable for the trial |
Condizioni oculari 1. Acuità visive (BCVA) di 20/200 o peggiore in uno dei due occhi 2. Malattie retiniche clinicamente significative o progressive (es. Degenerazioni, retinopatie diabetiche, distaccamenti della retina) 3. Glaucoma ad angolo aperto severo (MD maggiore di -12dB nell’occhio peggiore) 4. Chirurgia oculare o laser entro tre mesi precedenti allo screening 5. Ipersensibilità agli analoghi della prostaglandina o ingredienti dei prodotti in studio (Latanoprost, benzalconio cloridrato) 6. Uso di lenti a contatto 7. Glaucoma ad angolo chiuso 8. Procedure oculari filtranti Esclusioni generali 9. Donne: incinte, in allattamento o che programmano una gravidanza entro 12 mesi. (Donne in età fertile si sottoporranno a un test di gravidanza; verrà richiesto l’uso di due metodi contraccettivi durante lo studio- metodi ormonali come pillola contraccettiva e condom) 10. Soggetti che stanno partecipando in un altro studio clinico con farmaco o dispositivo investigazionale che può interferire con i risultati di altri studi clinici 11. Soggetti legalmente o mentalmente incapaci che forniscono il loro consenso alla partecipazione in questo studio 12. Pazienti vulnerabili 13. Soggetti che sono inabili o riluttanti ad assicurare appuntamenti o tutti gli altri requisiti del protocollo Condizioni mediche 14. Storia di malattie corniche neurodegenerative 15. Malattie infiammatorie o infettive, attive nel momento dell’entrata nello studio. 16. Lesioni o traumi non risolti al momento dell’arruolamento nello studio 17. Abuso di sostanze positive (droghe illegali). 18. Condizioni che, a giudizio del medico, possono rendere i pazienti inadatti allo studio |
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E.5 End points |
E.5.1 | Primary end point(s) |
Evaluate of the non-inferiority of preservative-free Latanoprost (Genetic Spa) as compared with Xalatan (Pfizer) in decreasing mean IOP (evaluated with Goldmann applanation tonometry) in subjects with POAG or OH after treatment for 6 months. |
Valutare la non inferiorità del Latanoprost senza conservanti (Genetic Spa) rispetto a Xalatan (Pfizer) nella diminuzione della IOP media (valutato con tonometro Goldmann) in soggetti con POAG o OH dopo un trattamento di 6 mesi. |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
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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 | Yes |
E.8.1.3 | Single blind | No |
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.8.2.4 | Number of treatment arms in the trial | 2 |
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 | 4 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 5 |
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 | 0 |
E.8.9.1 | In the Member State concerned months | 9 |
E.8.9.1 | In the Member State concerned days | 0 |
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 | 9 |
E.8.9.2 | In all countries concerned by the trial days | 0 |