Topical Cyclosporine-A for Management of Epiphora

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

Detailed Description
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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

Official Title
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Topical Cyclosporine-A for Management of Epiphora in Eyes With Acquired Punctal Stenosis

Conditions
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Epiphora

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


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cyclosporine A<br>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. | Drug: topical 0.05% CsA (Restasis®, Allergan Inc, Irvine, California)twice daily dose,<br>* topical preservative free artificial tears Q.I. D.<br>* Other names: preservative free artificial tears;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Epiphora grading | Munk grading system score from 0 to 5 the higher the worse | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fluorescein dye disappearance test (FDT) | via installing a drop of 2% fluorescein and asses the height of the tear film in millimeters | 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cyclosporine A, Epiphora, punctal stenosis