Status:
COMPLETED
Cyclosporine 0.1% Eye Drops as Prophylactic Treatment In Cataract Surgery
Lead Sponsor:
Campus Bio-Medico University
Conditions:
Ocular Surface Disease
Ocular Inflammation
Eligibility:
All Genders
18+ years
Phase:
EARLY_PHASE1
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 c...
Eligibility Criteria
Inclusion
- \>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
- 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
Key Trial Info
Start Date :
February 17 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 23 2022
Estimated Enrollment :
101 Patients enrolled
Trial Details
Trial ID
NCT04812951
Start Date
February 17 2021
End Date
February 23 2022
Last Update
February 14 2023
Active Locations (1)
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1
University Campus Bio Medico
Rome, Italy, 00128