Topical Cyclosporine-A for Management of Epiphora (CSA-epiphora)

Farwaniya Hospital

Status and phase: Completed; Phase 3; Phase 2

Conditions: Epiphora

Treatments: Drug: topical 0.05% CsA (Restasis®, Allergan Inc, Irvine, California)twice daily dose,

Study type: Interventional

Funder types: Other

Identifiers

NCT04637633

Farwanyia Hospital

Details and patient eligibility

About

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

Full 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

Enrollment: 12 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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12 participants in 1 patient group

Cyclosporine A

Experimental group

Description:

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.

Treatment:

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