Cyclosporine 0.1% Eye Drops as Prophylactic Treatment In Cataract Surgery (CSA2020)

Campus Bio-Medico University of Rome

Status and phase: Completed; Early Phase 1

Conditions: Ocular Inflammation; Ocular Surface Disease

Treatments: Device: cationorm eye drops; Drug: CycloSPORINE Ophthalmic 0.1% Ophthalmic Emulsion

Study type: Interventional

Funder types: Other

Identifiers

NCT04812951

CSA2020

Details and patient eligibility

About

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

Full 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.

Enrollment: 101 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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101 participants in 4 patient groups

young control

No Intervention group

Description:

25 patients \< 65 years old without any prophylactic anti-inflammatory preoperative treatment

control

No Intervention group

Description:

25 patients \> 75 years old without any prophylactic anti-inflammatory preoperative treatment

Study group

Experimental group

Description:

25 patients \> 75 years old with prophylactic anti-inflammatory preoperative treatment

Treatment:

Drug: CycloSPORINE Ophthalmic 0.1% Ophthalmic Emulsion

Vehicle group

Active Comparator group

Description:

25 patients \> 75 years old with vehicle preoperative treatment

Treatment:

Device: cationorm eye drops