Ocular Inflammation, Ocular Surface Disease
Conditions
Keywords
ocular surface disease
Brief summary
Use of Cyclosporine 0.1% Eye Drops as Prophylactic Treatment in cataract Surgery
Detailed description
To asses ocular discomfort symptoms and signs and inflammatory biomarkers after preoperative topical cyclosporine 0.1% eye drops therapy in high risk elder population after a specific insult such as cataract surgery.
Interventions
DRUGCycloSPORINE Ophthalmic 0.1% Ophthalmic Emulsion
one cyclosporine 0.1% eye drop twice a day for 30 preoperative days
DEVICEcationorm eye drops
one cationorm eye drop twice a day for 30 preoperative days
Sponsors
Campus Bio-Medico University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* \>18 years old * Postmenopausal women for whom cataract surgery has been scheduled * Stage N2-3; C1-2 according (Lens Opacities classification System) LOCS * Willing to sign informed consent and fully participate to all length of the study * Patients without any previous medical history of ocular and/or systemic inflammatory, autoimmune or auto inflammatory disease * Patient with no history of ocular surgery * Patients without any previous or concomitant ocular diseases
Exclusion criteria
* Patients under topical or systemic anti- inflammatory drugs Patients with a concomitant diagnosis of glaucoma, or on therapy with antiglaucoma drugs * Patients on systemic or local therapy with drugs that alter the secretion of the tear film (beta blockers, antidepressants and psychotropics) * Patients with a history of allergic, congenital, autoimmune systemic diseases * Patients who have undergone previous eye surgery * Ocular or peri-ocular malignancies or premalignant conditions * Active or suspected ocular or peri-ocular infection. * Complicated Cataract Surgery * Patients with a positive pregnancy testAllergy or reaction history to study drug * Patients who participated in a clinical trial in which an investigational drug was administered within 30 days or 5 half-lives of the study drug
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Symptoms Assessment Questionnaire iN Dry Eye | 4 months | SANDE (frequency and severity scores; 0-100) |
| National Eye Institute grading scale | 4 months | NEI corneal staining ( n/15 score; 0-15) |
| Rate of tears' production | 4 months | Schirmer test (mm/5min) |
| Tears Break Up Time | 4 months | T-BUT (Seconds) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Biomarkers' expression in conjunctival epithelial cells | 4 months | HLA DR (molecular expression) |
Countries
Italy
Outcome results
None listed