E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
High-risk patients, i.e. elder patients, who show dry eye syndrome after insult. |
Pazienti ad alto rischio, ovvero gli anziani, che hanno maggiori possibilità di sviluppare la sindrome dell'occhio secco in seguito a insulto esterno |
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E.1.1.1 | Medical condition in easily understood language |
Elderly patients who more likely would develop dry eye syndrome after insult. |
Pazienti anziani che hanno maggiori possibilità di sviluppare la sindrome dell'occhio secco dopo stimolo esterno. |
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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 | 21.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10013777 |
E.1.2 | Term | Dry eye syndrome |
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 |
Compare the symptoms of ocular discomfort (SANDE validated questionnaire) and the biomarkers of inflammation after a specific insult such as cataract surgery among patients over 75 years of age, i.e. at high risk of decompensation of the ocular surface, treated with cyclosporine (CsA) 0.1% topical (group C), untreated (group B), vehicle-treated (group D) and patients under the age of 65, i.e. not high risk, untreated (group A). |
Confrontare i sintomi di discomfort oculare (questionario validato SANDE) ed i biomarkers di infiammazione dopo un insulto specifico come la chirurgia della cataratta tra pazienti con età superiore ai 75 anni, ovvero ad alto rischio di scompenso della superficie oculare, trattati con ciclosporina (CsA) 0.1% topica (gruppo C), non trattati (gruppo B), trattati con veicolo (gruppo D) e pazienti con età inferiore a 65 anni, ovvero non ad alto rischio, non trattati (gruppo A). |
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E.2.2 | Secondary objectives of the trial |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Inclusion criterion • Signature of informed consent and willingness to participate in the study for its entire duration • Cataract of degrees N2-3; C1-2 according to (Lens Opacity Classification System) LOCS • Post-menopausal women and men over the age of 18 for whom cataract surgery has been scheduled • Patient without previous inflammatory and / or autoimmune ocular and / or systemic pathologies • Patient without previous ocular surgery • Patient without previous or concomitant ocular pathologies |
Criteri di inclusione • Firma del consenso informato e disponibilità a partecipare allo studio per tutta la sua durata • Cataratta di gradi N2-3; C1-2 secondo (Lens Opacities classification System) LOCS • Donne in età post-menopausale e uomini con età maggiore di 18 anni per i quali è stato programmato un intervento di cataratta • Paziente privo di qualsiasi precedente patologia infiammatoria e/o autoimmune oculare e/o sistemica • Paziente senza precedenti interventi chirurgici oculari • Paziente senza nessuna patologia oculare precedente o concomitante |
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E.4 | Principal exclusion criteria |
Exclusion criteria • Patients under topical or systemic therapy with anti-inflammatory drugs • Presence of ocular or peri-ocular malignant or premalignant neoplasms • Active or suspected ocular or periocular infections • Complicated cataract • History of drug allergy under study |
Criteri di esclusione • Pazienti sotto terapia topica o sistemica con farmaci antifiammatori • Presenza di neoplasie maligne o premaligne oculari o peri-oculari • Infezioni oculari o perioculari attive o sospette • Cataratta complicata • Storia di allergia ai farmaci in studio |
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E.5 End points |
E.5.1 | Primary end point(s) |
To evaluate signs and symptoms of ocular discomfort and inflammatory biomarkers after prophylactic treatment with topical 0.1% cyclosporine in elderly patients at high risk of decompensation of the ocular surface following harmful insults such as cataract surgery. |
Valutare i segni e i sintomi di discomfort oculare e i biomarker infiammatori dopo trattamento profilattico con ciclosporina 0.1% topica in pazienti anziani ad alto rischio di scompenso della superficie oculare in seguito ad insulti dannosi come la chirurgia della cataratta. |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
At screening phase, and T0, T1, T2, T3, T4. |
In fase di Screening, al tempo T0, T1, T2, T3, T4. |
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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 | No |
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) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
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 | 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) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
IMP di controllo |
control imp |
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E.8.2.4 | Number of treatment arms in the trial | 4 |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.4.1 | Number of sites anticipated in Member State concerned | 1 |
E.8.5 | The trial involves multiple Member States | No |
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 | 2 |
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 | 2 |