Cyclosporine 0.1% Eye Drops as Prophylactic Treatment In Cataract Surgery

• Status: Recruiting
• Trial end date: 2021-10-15
• Target enrollment: 0
• Participant gender: All

Summary

Use of Cyclosporine 0.1% Eye Drops as Prophylactic Treatment in cataract Surgery

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Campus Bio-Medico University
• Treatments: Cyclosporine; Cyclosporins; Ophthalmic Solutions

Criteria

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