Cyclosporine 0.1% Eye Drops as Prophylactic Treatment In Cataract Surgery

Study Overview
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Brief Summary
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Use of Cyclosporine 0.1% Eye Drops as Prophylactic Treatment in cataract Surgery

Detailed Description
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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.

Official Title
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Cyclosporine 0.1% Eye Drops as Prophylactic Treatment in Post Surgical Ocular Surface System Failure Within The Age

Conditions
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Ocular Surface Disease, Ocular Inflammation

Intervention / Treatment
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* Drug: CycloSPORINE Ophthalmic 0.1% Ophthalmic Emulsion
* Device: cationorm eye drops


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: young control<br>25 patients < 65 years old without any prophylactic anti-inflammatory preoperative treatment | |
| No Intervention: control<br>25 patients > 75 years old without any prophylactic anti-inflammatory preoperative treatment | |
| Experimental: Study group<br>25 patients > 75 years old with prophylactic anti-inflammatory preoperative treatment | Drug: CycloSPORINE Ophthalmic 0.1% Ophthalmic Emulsion<br>* one cyclosporine 0.1% eye drop twice a day for 30 preoperative days<br>* Other names: Ikervis eye drops;|
| Active Comparator: Vehicle group<br>25 patients > 75 years old with vehicle preoperative treatment | Device: cationorm eye drops<br>* one cationorm eye drop twice a day for 30 preoperative days<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Symptoms Assessment Questionnaire iN Dry Eye | SANDE (frequency and severity scores; 0-100) | 4 months | 
| National Eye Institute grading scale | NEI corneal staining ( n/15 score; 0-15) | 4 months | 
| Rate of tears' production | Schirmer test (mm/5min) | 4 months | 
| Tears Break Up Time | T-BUT (Seconds) | 4 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Biomarkers' expression in conjunctival epithelial cells | HLA DR (molecular expression) | 4 months | 
| Biomarkers' expression in conjunctival epithelial cells | ICAM-1 (molecular expression) | 4 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ocular surface disease