Topical Cyclosporine-A for Management of Epiphora

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

Status

Completed

Phases

Phase 2Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04637633

Acronym

CSA-epiphora

Enrollment

Registered

2020-11-20

Start date

2020-08-15

Completion date

2020-11-01

Last updated

2020-11-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Epiphora

Keywords

cyclosporine A, Epiphora, punctal stenosis

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

Interventions

DRUGtopical 0.05% CsA (Restasis®, Allergan Inc, Irvine, California)twice daily dose,

topical preservative free artificial tears Q.I. D.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame	Description
Epiphora grading	3 months	Munk grading system score from 0 to 5 the higher the worse

Secondary

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

Countries

Kuwait

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026