Cyclosporine Eye Drops as prophylactic treatment of dry eye
- Conditions
- High-risk patients, i.e. elder patients, who show dry eye syndrome after insult.MedDRA version: 21.1Level: LLTClassification code 10013777Term: Dry eye syndromeSystem Organ Class: 100000004853Therapeutic area: Diseases [C] - Eye Diseases [C11]
- Registration Number
- EUCTR2020-001720-33-IT
- Lead Sponsor
- IVERSITÀ CAMPUS BIO-MEDICO DI ROMA
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 100
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
• 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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method