Topical Cyclosporine-A for Management of Epiphora

Phase 2

Completed

• Conditions: Epiphora
• Interventions: Drug: topical 0.05% CsA (Restasis®, Allergan Inc, Irvine, California)twice daily dose,

• Registration Number: NCT04637633
• Lead Sponsor: Farwaniya Hospital

Brief Summary

to investigate the clinical outcomes and tolerances of Cyclosporine A (CsA) in treating epiphora in eyes with acquired punctum stenosis

Detailed Description

a prospective study included patients who were referred to our outpatient clinics in Farwanyia hospital, Kuwait during the period between July 2019 and January 2020, having symptomatic epiphora associated with severe acquired lower punctal stenosis. Patients were treated with topical 0.05% CsA on twice daily dose with topical preservative free artificial tears Q.I. D. Patients were followed up monthly for at least 3 months by epiphora grading, Fluorescein dye disappearance test (FDT) and evaluating the patient satisfaction

Study Timeline

• Study First Submitted: 2020-07-29
• Study Start: 2020-08-15
• Primary Completion: 2020-10-30
• Status Verified: 2020-11
• Study Completion: 2020-11-01
• Study First Submitted QC: 2020-11-15
• Last Update Submitted: 2020-11-19
• Study First Posted: 2020-11-20
• Last Update Posted: 2020-11-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

Inclusion Criteria

• Adult patients of either sex
• had a diagnosis of epiphora that persisted more than three months both indoors and outdoors
• grade 0 punctal stenosis
• did not adequately respond to artificial tears, topical corticosteroids and topical antibiotics or in whom corticosteroids were discontinued due to their side effects.

Exclusion Criteria

• congenital punctal obstruction
• edematous puncti
• allergic conjunctivitis
• history of dacryocystitis,
• inflammatory systemic diseases
• any previous chemotherapy treatment, and local irradiation.
• other causes of epiphora, lid laxity, entropion, and ectropion
• lid malposition, canalicular or nasolacrimal sac or duct obstruction
• previous eyelid or lacrimal drainage surgery
• untreated conjunctivitis or blepharitis

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Cyclosporine A	topical 0.05% CsA (Restasis®, Allergan Inc, Irvine, California)twice daily dose,	All patients were treated with topical 0.05% CsA (Restasis®, Allergan Inc, Irvine, California) on twice daily dose, in addition to the topical preservative free artificial tears Q.I. D.

Primary Outcome Measures

Name	Time	Method
Epiphora grading	3 months	Munk grading system score from 0 to 5 the higher the worse

Secondary Outcome Measures

Name	Time	Method
Fluorescein dye disappearance test (FDT)	3 months	via installing a drop of 2% fluorescein and asses the height of the tear film in millimeters

Trial Locations

Locations (1)

Farwanyia Hospital; 🇰🇼 Kuwait, Farwanyia, Kuwait