High-risk patients, i.e. elder patients, who show dry eye syndrome after insult. MedDRA version: 21.1 Level: LLT Classification code 10013777 Term: Dry eye syndrome System Organ Class: 100000004853
Conditions
Interventions
Trade Name: Cationorm
Product Name: Cationorm
Product Code: [A939989087 MINSAL]
Pharmaceutical Form: Eye drops, suspension
Current Sponsor code: 120915
Concentration unit: ml millilitre(s)
Concentrati
Sponsors
UNIVERSITÀ CAMPUS BIO-MEDICO DI ROMA
Eligibility
Sex/Gender
All
Inclusion criteria
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 Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 25 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 75
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 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).;Secondary Objective: n.a.;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.;Timepoint(s) of evaluation of this end point: At screening phase, and T0, T1, T2, T3, T4. | — |
Countries
Italy
Contacts
Public ContactClinical Innovation Office (CIO)
Università Campus Bio-Medico di Roma
Outcome results
None listed