Cyclosporine 0.1% Eye Drops as Prophylactic Treatment In Cataract Surgery

Early Phase 1

Completed

• Conditions: Ocular Surface Disease; Ocular Inflammation
• Interventions: Drug: CycloSPORINE Ophthalmic 0.1% Ophthalmic Emulsion; Device: cationorm eye drops

• Registration Number: NCT04812951
• Lead Sponsor: Campus Bio-Medico University

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.

Study Timeline

• Study Start: 2021-02-17
• Study First Submitted: 2021-03-15
• Study First Submitted QC: 2021-03-19
• Study First Posted: 2021-03-24
• Primary Completion: 2021-06-18
• Study Completion: 2022-02-23
• Status Verified: 2023-02
• Last Update Submitted: 2023-02-13
• Last Update Posted: 2023-02-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 101

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Study group	CycloSPORINE Ophthalmic 0.1% Ophthalmic Emulsion	25 patients \> 75 years old with prophylactic anti-inflammatory preoperative treatment
Vehicle group	cationorm eye drops	25 patients \> 75 years old with vehicle preoperative treatment

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Biomarkers' expression in conjunctival epithelial cells	4 months	ICAM-1 (molecular expression)

Trial Locations

Locations (1)

University Campus Bio Medico; 🇮🇹 Rome, Italy